1 1724 140 PERCEPTIONS OF MYELOPROLIFERATIVE NEOPLASM PATIENTS PARTICIPATING IN AN ONLINE YOGA INTERVENTION: A QUALITATIVE STUDY. MYELOPROLIFERATIVE NEOPLASMS (MPNS) ARE RARE HEMATOLOGICAL MALIGNANCIES WITH A SIGNIFICANT SYMPTOM BURDEN OFTEN LEFT UNRESOLVED DESPITE RECENT ADVANCES IN PHARMACOLOGICAL THERAPY. YOGA IS A NONPHARMACOLOGICAL STRATEGY THAT HAS BEEN SHOWN TO IMPROVE SYMPTOMS IN OTHER CANCERS AND MAY BE EFFECTIVE FOR IMPROVING SYMPTOMS IN MPN PATIENTS. ONLINE YOGA HELPS ADDRESS MANY OF THE COMMONLY REPORTED BARRIERS OF CANCER PATIENTS TO IN-PERSON INTERVENTIONS AND MAY MAKE YOGA MORE ACCESSIBLE TO MPNS. AN EXPLORATION OF MPN PATIENT PERCEPTIONS OF PARTICIPATION IN ONLINE YOGA IS NEEDED TO TAILOR INTERVENTIONS TO PATIENT NEEDS AND INFORM FUTURE STUDIES. THE PURPOSE OF THIS STUDY WAS TO EXPLORE THE PERCEPTIONS OF MPN PATIENTS PARTICIPATING IN A 12-WEEK ONLINE YOGA INTERVENTION. THIS ARTICLE REPRESENTS THE COMBINED QUALITATIVE INTERVIEW DATA FROM TWO STUDIES. PARTICIPANTS WERE ASKED TO COMPLETE 60 MIN/WK OF ONLINE, HOME-BASED YOGA AND WERE ASKED TO PARTICIPATE IN A 15- TO 20-MINUTE PHONE INTERVIEW POSTINTERVENTION. THE QUALITATIVE DATA WAS CODED IN NVIVO 11 FOR CONTENT ANALYSIS. THE TOTAL SAMPLE INCLUDED 39 MPN PATIENTS. ONLINE YOGA WAS WELL ACCEPTED AND LIKED AMONG THESE PATIENTS. THEY REPORTED PHYSICAL (EG, IMPROVED SLEEP, REDUCED FATIGUE) AND MENTAL (EG, REDUCED STRESS) HEALTH BENEFITS AND LIKED THE CONVENIENCE OF BEING ABLE TO DO YOGA AT HOME. ONLINE YOGA PROVIDES A FEASIBLE AND ATTRACTIVE FORMAT THROUGH WHICH TO DELIVER A NONPHARMACOLOGICAL INTERVENTION AMONG MPN PATIENTS. RANDOMIZED CONTROLLED TRIALS ARE NEEDED TO CONFIRM THE EFFECTS OF ONLINE YOGA ON MPN PATIENT SYMPTOMS. THE QUALITATIVE FINDINGS PRESENTED HERE HELP INFORM THE DEVELOPMENT OF THESE FUTURE TRIALS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
2  199  25 A RESEARCH PROTOCOL FOR A PILOT, RANDOMIZED CONTROLLED TRIAL DESIGNED TO EXAMINE THE FEASIBILITY OF A DYADIC VERSUS INDIVIDUAL YOGA PROGRAM FOR FAMILY CAREGIVERS OF GLIOMA PATIENTS UNDERGOING RADIOTHERAPY. BACKGROUND: ALTHOUGH THE DIAGNOSIS AND TREATMENT OF A PRIMARY BRAIN TUMOR PRESENT UNIQUE CHALLENGES TO PATIENTS AND THEIR FAMILY CAREGIVERS, EVIDENCE-BASED SUPPORTIVE CARE INTERVENTIONS ARE GENERALLY LACKING. THE PRIMARY AIM OF THIS RESEARCH PROTOCOL IS TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A DYADIC YOGA (DY) VERSUS A CAREGIVER YOGA (CY) INTERVENTION OR A WAIT-LIST CONTROL (WLC) GROUP USING A RANDOMIZED CONTROLLED TRIAL DESIGN. METHODS: SEVENTY-FIVE GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS ARE RANDOMIZED TO THE DY, CY, OR A WLC GROUP. PATIENT-CAREGIVER DYADS IN THE DY GROUP AND CAREGIVERS IN THE CY GROUP RECEIVE 15 SESSIONS (45 MIN EACH) OVER THE COURSE OF PATIENTS' STANDARD RADIOTHERAPY (6 WEEKS). PATIENTS AND CAREGIVERS IN ALL GROUPS COMPLETE BASELINE ASSESSMENTS OF SYMPTOMS, QUALITY OF LIFE (QOL), AND HEALTH UTILIZATION OUTCOMES PRIOR TO RANDOMIZATION. FOLLOW-UP ASSESSMENTS ARE PERFORMED 6 WEEKS AND THEN AGAIN 3 MONTHS LATER. THE PRIMARY OUTCOME IS FEASIBILITY (I.E., >/= 50% OF ELIGIBLE DYADS CONSENT, >/= 70% OF ENROLLED DYADS COMPLETE ALL ASSESSMENTS, AND >/= 50% OF ALL PRACTICE SESSIONS ARE ATTENDED). WE WILL ALSO PERFORM PRIMARILY DESCRIPTIVE ANALYSES OF THE SELF-REPORTED OUTCOMES (E.G., FATIGUE, OVERALL QOL) AND EXPLORE POTENTIAL INTERVENTION MODERATORS (E.G., PERFORMANCE STATUS) TO INFORM A LARGER FUTURE TRIAL. CONCLUSION: THIS TRIAL WILL PROVIDE IMPORTANT INFORMATION REGARDING THE FEASIBILITY OF A DYADIC VERSUS A CAREGIVER YOGA INTERVENTION REGARDING SYMPTOM, QOL, AND HEALTH UTILIZATION OUTCOMES IN GLIOMA PATIENTS AND THEIR CAREGIVERS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02481349.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
3  258  38 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017.	2019	
                                                                                                                                                                                                                                                          
4 1748  35 PILOT RANDOMIZED, CONTROLLED TRIAL OF A DYADIC YOGA PROGRAM FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS. BACKGROUND: WHILE THE USE OF BEHAVIORAL MEDICINE IN MANAGING GLIOMA PATIENTS' SYMPTOMS IS NOT WELL STUDIED, THE HIGH SYMPTOM BURDEN IN PATIENTS AND THEIR FAMILY CAREGIVERS IS WELL ESTABLISHED. WE CONDUCTED A PILOT RANDOMIZED, CONTROLLED TRIAL TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFICACY OF A DYADIC YOGA (DY) INTERVENTION AS A SUPPORTIVE CARE STRATEGY. METHODS: GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS WERE RANDOMIZED TO A 12-SESSION DY OR WAITLIST CONTROL (WLC) GROUP. PRIOR TO RADIOTHERAPY AND RANDOMIZATION, BOTH GROUPS COMPLETED MEASURES OF CANCER-RELATED SYMPTOMS (MD ANDERSON SYMPTOM INVENTORY-BRAIN TUMOR MODULE), DEPRESSIVE SYMPTOMS (CENTER FOR EPIDEMIOLOGICAL STUDIES-DEPRESSION MEASURE), FATIGUE (BRIEF FATIGUE INVENTORY), AND OVERALL QUALITY OF LIFE (QOL; MEDICAL OUTCOMES STUDY 36-ITEM SHORT-FORM SURVEY). DYADS WERE REASSESSED AT THE LAST DAY OF RADIOTHERAPY. RESULTS: TWENTY PATIENTS (MEAN AGE: 46 YEARS, 50% FEMALE, 80% WHO GRADE IV AND CAREGIVERS (MEAN AGE: 50 YEARS, 70% FEMALE, 50% SPOUSES) PARTICIPATED IN THE TRIAL. A PRIORI FEASIBILITY CRITERIA WERE MET REGARDING CONSENT (70%), ADHERENCE (88%), AND RETENTION (95%) RATES. CONTROLLING FOR RELEVANT COVARIATES, CHANGE SCORE ANALYSES REVEALED CLINICALLY SIGNIFICANT IMPROVEMENTS FOR PATIENTS IN THE DY COMPARED WITH THE WLC GROUP FOR OVERALL CANCER SYMPTOM SEVERITY (D = 0.96) AND SYMPTOM INTERFERENCE (D = 0.74), DEPRESSIVE SYMPTOMS (D = 0.71), AND MENTAL QOL (D = 0.69). CAREGIVERS IN THE DY GROUP REPORTED CLINICALLY SIGNIFICANT IMPROVEMENTS IN DEPRESSIVE SYMPTOMS (D = 1.12), FATIGUE (D = 0.89), AND MENTAL QOL (D = 0.49) RELATIVE TO THOSE IN THE WLC GROUP. CONCLUSION: A DY INTERVENTION APPEARS TO BE A FEASIBLE AND BENEFICIAL SYMPTOM AND QOL MANAGEMENT STRATEGY FOR GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR CAREGIVERS. AN EFFICACY TRIAL WITH A MORE STRINGENT CONTROL GROUP IS WARRANTED. CLINICAL TRIAL NUMBER: NCT02481349.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
5  319  52 AN INTERVENTION WITH DANCE AND YOGA FOR GIRLS WITH FUNCTIONAL ABDOMINAL PAIN DISORDERS (JUST IN TIME): PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: FUNCTIONAL ABDOMINAL PAIN DISORDERS (FAPDS) AFFECT MANY CHILDREN WORLDWIDE, PREDOMINANTLY GIRLS, AND CAUSE CONSIDERABLE LONG-TERM NEGATIVE CONSEQUENCES FOR INDIVIDUALS AND SOCIETY. EVIDENCE-BASED AND COST-EFFECTIVE TREATMENTS ARE THEREFORE STRONGLY NEEDED. PHYSICAL ACTIVITY HAS SHOWN PROMISING EFFECTS IN THE PRACTICAL MANAGEMENT OF FAPDS. DANCE AND YOGA ARE BOTH POPULAR ACTIVITIES THAT HAVE BEEN SHOWN TO PROVIDE SIGNIFICANT PSYCHOLOGICAL AND PAIN-RELATED BENEFITS WITH MINIMAL RISK. THE ACTIVITIES COMPLEMENT EACH OTHER, IN THAT DANCE INVOLVES DYNAMIC, RHYTHMIC PHYSICAL ACTIVITY, WHILE YOGA ENHANCES RELAXATION AND FOCUS. OBJECTIVE: THIS STUDY AIMS TO EVALUATE THE EFFECTS OF A DANCE AND YOGA INTERVENTION AMONG GIRLS AGED 9 TO 13 YEARS WITH FAPDS. METHODS: THE STUDY IS A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL AMONG GIRLS AGED 9 TO 13 YEARS WITH FUNCTIONAL ABDOMINAL PAIN, IRRITABLE BOWEL SYNDROME, OR BOTH. THE TARGET SAMPLE SIZE WAS 150 GIRLS RANDOMIZED INTO 2 ARMS: AN INTERVENTION ARM THAT RECEIVES DANCE AND YOGA SESSIONS TWICE WEEKLY FOR 8 MONTHS AND A CONTROL ARM THAT RECEIVES STANDARD CARE. OUTCOMES WILL BE MEASURED AT BASELINE AND AFTER 4, 8, 12, AND 24 MONTHS, AND LONG-TERM FOLLOW-UP WILL BE CONDUCTED 5 YEARS FROM BASELINE. QUESTIONNAIRES, INTERVIEWS, AND BIOMARKER MEASURES, SUCH AS CORTISOL IN SALIVA AND FECAL MICROBIOTA, WILL BE USED. THE PRIMARY OUTCOME IS THE PROPORTION OF GIRLS IN EACH GROUP WITH REDUCED PAIN, AS MEASURED BY THE FACES PAIN SCALE-REVISED IN A PAIN DIARY, IMMEDIATELY AFTER THE INTERVENTION. SECONDARY OUTCOMES ARE GASTROINTESTINAL SYMPTOMS, GENERAL HEALTH, MENTAL HEALTH, STRESS, AND PHYSICAL ACTIVITY. THE STUDY ALSO INCLUDES QUALITATIVE EVALUATIONS AND HEALTH ECONOMIC ANALYSES. THIS STUDY WAS APPROVED BY THE REGIONAL ETHICAL REVIEW BOARD IN UPPSALA (NO. 2016/082 1-2). RESULTS: DATA COLLECTION BEGAN IN OCTOBER 2016. THE INTERVENTION HAS BEEN PERFORMED IN 3 PERIODS FROM 2016 THROUGH 2019. THE FINAL 5-YEAR FOLLOW-UP IS ANTICIPATED TO BE COMPLETED BY FALL 2023. CONCLUSIONS: COST-EFFECTIVE AND EASILY ACCESSIBLE INTERVENTIONS ARE WARRANTED TO REDUCE THE NEGATIVE CONSEQUENCES ARISING FROM FAPDS IN YOUNG GIRLS. PHYSICAL ACTIVITY IS AN EFFECTIVE STRATEGY, BUT INTERVENTION STUDIES ARE NEEDED TO BETTER UNDERSTAND WHAT TYPES OF ACTIVITIES FACILITATE REGULAR PARTICIPATION IN THIS TARGET GROUP. THE JUST IN TIME (TRY, IDENTIFY, MOVE, AND ENJOY) STUDY WILL PROVIDE INSIGHTS REGARDING THE EFFECTIVENESS OF DANCE AND YOGA AND IS ANTICIPATED TO CONTRIBUTE TO THE CHALLENGING WORK OF REDUCING THE BURDEN OF FAPDS FOR YOUNG GIRLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV (NCT02920268); HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT02920268. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19748.	2020	

6  816  30 EFFECT OF YOGA ON CLINICAL OUTCOMES AND QUALITY OF LIFE IN PATIENTS WITH VASOVAGAL SYNCOPE (LIVE-YOGA). OBJECTIVES: THIS STUDY AIMS TO DETERMINE THE IMPACT OF YOGA AS AN ADJUNCT TO STANDARD THERAPY VERSUS STANDARD THERAPY ALONE ON THE SYMPTOMATIC BURDEN IN PATIENTS WITH RECURRENT VASOVAGAL SYNCOPE (VVS). BACKGROUND: THERE IS A SIGNIFICANT REDUCTION IN THE QUALITY OF LIFE (QOL) OF PATIENTS WITH RECURRENT VVS. EXISTING MANAGEMENT THERAPIES HAVE BEEN LARGELY INEFFECTIVE. RECENT TRIALS HAVE DEMONSTRATED THE EFFICACY OF YOGA IN DISEASES WITH AUTONOMIC IMBALANCE, SUGGESTING ITS POSSIBLE UTILITY IN VVS. METHODS: PATIENTS WITH RECURRENT VVS WERE RANDOMIZED TO RECEIVE EITHER A SPECIALIZED YOGA TRAINING PROGRAM IN ADDITION TO CURRENT GUIDELINE-BASED THERAPY (INTERVENTION ARM, GROUP 1) OR CURRENT GUIDELINE-BASED THERAPY ALONE (CONTROL ARM, GROUP 2). THE PRIMARY OUTCOME WAS A COMPOSITE OF THE NUMBER OF EPISODES OF SYNCOPE AND PRESYNCOPE AT 12 MONTHS. SECONDARY OUTCOMES INCLUDED QOL ASSESSMENT BY WORLD HEALTH ORGANIZATION QUALITY OF LIFE BRIEF FIELD QUESTIONNAIRE (WHOQOL-BREF) SCORES AND SYNCOPE FUNCTIONAL STATUS QUESTIONNAIRE SCORES AT 12 MONTHS, HEAD UP TILT TEST, AND HEART RATE VARIABILITY AT 6 WEEKS. RESULTS: A TOTAL OF 55 PATIENTS UNDERWENT RANDOMIZATION. THE MEAN NUMBER OF SYNCOPAL OR PRESYNCOPAL EVENTS AT 12 MONTHS WAS 0.7 +/- 0.7 IN THE INTERVENTION ARM COMPARED TO 2.52 +/- 1.93 IN THE CONTROL ARM (P < 0.01). IN THE INTERVENTION ARM, 13 (43.3%) PATIENTS REMAINED FREE OF EVENTS VERSUS 4 (16.0%) PATIENTS IN THE CONTROL ARM (P = 0.02). QOL AT 12 MONTHS SHOWED SIGNIFICANT IMPROVEMENT OF ALL SYNCOPE FUNCTIONAL STATUS QUESTIONNAIRE SCORES AND 2 DOMAINS OF WHOQOL-BREF SCORES (P < 0.05). CONCLUSIONS: YOGA AS ADJUNCTIVE THERAPY IS SUPERIOR TO STANDARD THERAPY ALONE IN REDUCING THE SYMPTOMATIC BURDEN AND IMPROVING QOL IN PATIENTS WITH RECURRENT VVS.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
7  551  36 CONVENIENT AND LIVE MOVEMENT (CALM) FOR WOMEN UNDERGOING BREAST CANCER TREATMENT: CHALLENGES AND RECOMMENDATIONS FOR INTERNET-BASED YOGA RESEARCH. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF INTERNET-BASED, CANCER-ADAPTED YOGA FOR WOMEN RECEIVING BREAST CANCER TREATMENT. DESIGN: WOMEN UNDERGOING RADIATION OR CHEMOTHERAPY FOR BREAST CANCER WERE RECRUITED FOR 12, 75-MIN, BIWEEKLY, CANCER-ADAPTED YOGA CLASSES DELIVERED VIA INTERNET-BASED, MULTIPOINT VIDEOCONFERENCING. DATA WERE COLLECTED ON FEASIBILITY AND ACCEPTABILITY, INCLUDING QUALITATIVE FEEDBACK FROM PARTICIPANTS AND THE YOGA INSTRUCTOR. RESULTS: AMONG 42 WOMEN APPROACHED, 13 DECLINED ELIGIBILITY SCREENING, AND 23 WERE INELIGIBLE. ALL 6 WOMEN WHO WERE ELIGIBLE PROVIDED CONSENT, BUT 2 WITHDREW PRIOR TO BEGINNING YOGA CLASSES. THE REMAINING 4 PARTICIPANTS ATTENDED 1-11 OF 12 ONLINE YOGA CLASSES. IN POST-INTERVENTION INTERVIEWS, PARTICIPANTS AND THE INSTRUCTOR AGREED THAT INTERNET-BASED YOGA CLASSES HOLD GREAT POTENTIAL FOR INCREASING ACCESS AND IMPROVING PSYCHOLOGICAL OUTCOMES IN ADULTS WITH CANCER. QUALITATIVE FEEDBACK FROM PARTICIPANTS REVEALED SUGGESTIONS FOR FUTURE TRIALS OF INTERNET-BASED, CANCER-ADAPTED YOGA CLASSES, INCLUDING: CONTINUED USE OF GROUP FORMAT; OFFERING MORE VARIED CLASS TIMES TO ACCOMMODATE PATIENTS' DEMANDING SCHEDULES AND FLUCTUATING SYMPTOMS; ENROLLING PATIENTS AFTER THEY HAVE ACCLIMATED TO OR COMPLETED CANCER TREATMENT; STREAMLINING THE TECHNOLOGY INTERFACE; AND CAREFUL ATTENTION TO PARTICIPANT BURDEN WHEN DESIGNING SURVEYS/FORMS. THE INSTRUCTOR RECOMMENDED CLOSED SESSION COURSES, AS OPPOSED TO ROLLING ENROLLMENT; TEACHING THE SAME MODIFIED POSES FOR ALL PARTICIPANTS, RATHER THAN INDIVIDUAL TAILORING; AND USING A LARGE SCREEN TO ALLOW CLOSER MONITORING OF STUDENTS' CLASS EXPERIENCE. CONCLUSIONS: INTERNET DELIVERY MAY INCREASE PATIENTS' ACCESS TO CANCER-ADAPTED YOGA CLASSES, BUT CANCER-RELATED AND TECHNOLOGICAL BARRIERS REMAIN. THIS STUDY INFORMS HOW TO OPTIMALLY DESIGN YOGA CLASSES, TECHNOLOGY, AND RESEARCH PROCEDURES TO MAXIMIZE FEASIBILITY AND ACCEPTABILITY IN FUTURE TRIALS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
8 1495  38 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
9 1093  43 EFFECTS OF YOGA ON WELL-BEING AND HEALTHY AGEING: STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (FITFORAGE). INTRODUCTION: DUE TO AGEING POPULATIONS WORLDWIDE, THE BURDEN OF DISABILITY IS INCREASING. IT IS THEREFORE IMPORTANT TO DEVELOP INTERVENTIONS THAT IMPROVE HEALTHY AGEING, REDUCE DISABILITY ONSET AND ENHANCE LIFE QUALITY. PHYSICAL ACTIVITY CAN PROMOTE HEALTHY AGEING AND HELP MAINTAIN INDEPENDENCE, YET MANY OLDER ADULTS ARE INACTIVE. YOGA IS A FORM OF PHYSICAL ACTIVITY THAT AIMS TO IMPROVE HEALTH AND MAY BE PARTICULARLY SUITABLE FOR OLDER ADULTS. RESEARCH INDICATES POSITIVE EFFECTS OF YOGA ON SEVERAL HEALTH-RELATED OUTCOMES; HOWEVER, EMPIRICAL STUDIES EXAMINING THE BENEFITS OF YOGA ON WELL-BEING AMONG THE ELDERLY REMAIN SCARCE. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 12-WEEK YOGA PROGRAMME AIMED TO IMPROVE HEALTH AND WELL-BEING AMONG PHYSICALLY INACTIVE OLDER ADULTS. METHODS AND ANALYSIS: THREE GROUP PARALLEL, SINGLE-BLIND RANDOMISED CONTROLLED TRIAL. TWO COMPARISON GROUPS ARE INCLUDED: AEROBIC EXERCISE AND A NON-ACTIVE WAIT-LIST CONTROL. IN TOTAL, 180 PARTICIPANTS AGED 65-85 YEARS WILL BE RECRUITED. ASSESSMENTS WILL BE PERFORMED AT BASELINE AND POSTINTERVENTION (12-WEEK FOLLOW-UP). THE PRIMARY OUTCOME IS SUBJECTIVE WELL-BEING. SECONDARY OUTCOMES INCLUDE PHYSICAL ACTIVITY/SEDENTARY BEHAVIOUR, MOBILITY/FALL RISK, COGNITION, DEPRESSION, ANXIETY, MOOD, STRESS, PAIN, SLEEP QUALITY, SOCIAL SUPPORT AND CARDIOMETABOLIC RISK FACTORS. DATA WILL BE ANALYSED USING INTENTION-TO-TREAT ANALYSES, WITH MIXED LINEAR MODELLING. ETHICS AND DISSEMINATION: THIS STUDY IS APPROVED BY THE ETHICAL REVIEW BOARD IN STOCKHOLM (2017/1862-31/2). ALL PARTICIPANTS MUST VOLUNTARILY AGREE TO PARTICIPATE AND ARE FREE TO WITHDRAW FROM THE STUDY AT ANY POINT. WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. A SUMMARY OF KEY RESULTS WILL BE PUBLICLY AVAILABLE THROUGH NEWSPAPER ARTICLES. TRIAL REGISTRATION NUMBER: DRKS00015093, U1111-1217-4248.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
10 2638  32 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
11 1682  56 ONLINE YOGA IN MYELOPROLIFERATIVE NEOPLASM PATIENTS: RESULTS OF A RANDOMIZED PILOT TRIAL TO INFORM FUTURE RESEARCH. BACKGROUND: MYELOPROLIFERATIVE NEOPLASM (MPN) PATIENTS SUFFER FROM SIGNIFICANT SYMPTOMS, INFLAMMATION AND REDUCED QUALITY OF LIFE. YOGA IMPROVES THESE OUTCOMES IN OTHER CANCERS, BUT THIS HASN'T BEEN DEMONSTRATED IN MPNS. THE PURPOSE OF THIS STUDY WAS TO: (1) EXPLORE THE LIMITED EFFICACY (DOES THE PROGRAM SHOW PROMISE OF SUCCESS) OF A 12-WEEK ONLINE YOGA INTERVENTION AMONG MPN PATIENTS ON SYMPTOM BURDEN AND QUALITY OF LIFE AND (2) DETERMINE FEASIBILITY (PRACTICALITY: TO WHAT EXTENT A MEASURE CAN BE CARRIED OUT) OF REMOTELY COLLECTING INFLAMMATORY BIOMARKERS. METHODS: PATIENTS WERE RECRUITED NATIONALLY AND RANDOMIZED TO ONLINE YOGA (60 MIN/WEEK OF YOGA) OR WAIT-LIST CONTROL (ASKED TO MAINTAIN NORMAL ACTIVITY). WEEKLY YOGA MINUTES WERE COLLECTED WITH CLICKY (ONLINE WEB ANALYTICS TOOL) AND SELF-REPORT. THOSE IN ONLINE YOGA COMPLETED A BLOOD DRAW AT BASELINE AND WEEK 12 TO ASSESS INFLAMMATION (INTERLEUKIN-6, TUMOR NECROSIS FACTOR-ALPHA [TNF-ALPHA]). ALL PARTICIPANTS COMPLETED QUESTIONNAIRES ASSESSING DEPRESSION, ANXIETY, FATIGUE, PAIN, SLEEP DISTURBANCE, SEXUAL FUNCTION, TOTAL SYMPTOM BURDEN, GLOBAL HEALTH, AND QUALITY OF LIFE AT BASELINE, WEEK SEVEN, 12, AND 16. CHANGE FROM BASELINE AT EACH TIME POINT WAS COMPUTED BY GROUP AND EFFECT SIZES WERE CALCULATED. PRE-POST INTERVENTION CHANGE IN INFLAMMATION FOR THE YOGA GROUP WAS COMPARED BY T-TEST. RESULTS: SIXTY-TWO MPN PATIENTS ENROLLED AND 48 COMPLETED THE INTERVENTION (ONLINE YOGA = 27; CONTROL GROUP = 21). YOGA PARTICIPATION AVERAGED 40.8 MIN/WEEK VIA CLICKY AND 56.1 MIN/WEEK VIA SELF-REPORT. SMALL/MODERATE EFFECT SIZES WERE GENERATED FROM THE YOGA INTERVENTION FOR SLEEP DISTURBANCE (D = - 0.26 TO - 0.61), PAIN INTENSITY (D = - 0.34 TO - 0.51), ANXIETY (D = - 0.27 TO - 0.37), AND DEPRESSION (D = - 0.53 TO - 0.78). A TOTAL OF 92.6 AND 70.4% OF ONLINE YOGA PARTICIPANTS COMPLETED THE BLOOD DRAW AT BASELINE AND WEEK 12, RESPECTIVELY, AND THERE WAS A DECREASE IN TNF-ALPHA FROM BASELINE TO WEEK 12 (- 1.3 +/- 1.5 PG/ML). CONCLUSIONS: ONLINE YOGA DEMONSTRATED SMALL EFFECTS ON SLEEP, PAIN, AND ANXIETY AS WELL AS A MODERATE EFFECT ON DEPRESSION. REMOTE BLOOD DRAW PROCEDURES ARE FEASIBLE AND THE EFFECT SIZE OF THE INTERVENTION ON TNF-ALPHA WAS LARGE. FUTURE FULLY POWERED RANDOMIZED CONTROLLED TRIALS ARE NEEDED TO TEST FOR EFFICACY. TRIAL REGISTRATION: THIS TRIAL WAS RETROSPECTIVELY REGISTERED WITH CLINICALTRIALS.GOV (ID: NCT03503838 ) ON 4/19/2018.	2019	
                                                                                                                                                                                                                                                                                                                                                                             
12   41  39 A BRIEF YOGA INTERVENTION IMPLEMENTED DURING CHEMOTHERAPY: A RANDOMIZED CONTROLLED PILOT STUDY. OBJECTIVES: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS (E.G., SLEEP DISTURBANCE) ARE CRITICAL TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS UNDERGOING CHEMOTHERAPY. YOGA MAY REDUCE THE BURDEN OF SUCH SYMPTOMS. THIS STUDY INVESTIGATED THE FEASIBILITY OF CONDUCTING A RANDOMIZED CONTROLLED STUDY OF A BRIEF YOGA INTERVENTION DURING CHEMOTHERAPY FOR COLORECTAL CANCER. DESIGN: WE RANDOMIZED ADULTS WITH COLORECTAL CANCER TO A BRIEF YOGA SKILLS TRAINING (YST) OR AN ATTENTION CONTROL (AC; EMPATHIC ATTENTION AND RECORDED EDUCATION). SETTING: THE INTERVENTIONS AND ASSESSMENTS WERE IMPLEMENTED INDIVIDUALLY IN THE CLINIC WHILE PATIENTS WERE IN THE CHAIR RECEIVING CHEMOTHERAPY. INTERVENTIONS: BOTH INTERVENTIONS CONSISTED OF THREE SESSIONS AND RECOMMENDED HOME PRACTICE. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS FEASIBILITY (ACCRUAL, RETENTION, ADHERENCE, DATA COLLECTION). SELF-REPORTED OUTCOMES (I.E., FATIGUE, SLEEP DISTURBANCE, QUALITY OF LIFE) AND INFLAMMATORY BIOMARKERS WERE ALSO DESCRIBED TO INFORM FUTURE STUDIES. RESULTS: OF 52 PATIENTS INITIALLY IDENTIFIED, 28 WERE APPROACHED, AND 15 ENROLLED (AGE MEAN = 57.5 YEARS; 80% WHITE; 60% MALE). REASONS FOR DECLINING PARTICIPATION WERE: NOT INTERESTED (N = 6), DID NOT PERCEIVE A NEED (N = 2), AND OTHER (N = 5). TWO PARTICIPANTS WERE LOST TO FOLLOW-UP IN EACH GROUP DUE TO TREATMENT CHANGES. THUS, 75% OF PARTICIPANTS WERE RETAINED IN THE YST AND 71% IN THE AC ARM. PARTICIPANTS RETAINED IN THE STUDY ADHERED TO 97% OF THE IN-PERSON INTERVENTION SESSIONS AND COMPLETED ALL QUESTIONNAIRES. CONCLUSIONS: THIS STUDY DEMONSTRATED THE FEASIBILITY OF CONDUCTING A LARGER RANDOMIZED CONTROLLED TRIAL TO ASSESS YST AMONG PATIENTS RECEIVING CHEMOTHERAPY FOR COLORECTAL CANCER. DATA COLLECTED AND CHALLENGES ENCOUNTERED WILL INFORM FUTURE RESEARCH.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
13  388  38 BENEFITS OF THE RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE YOGA PROGRAM FOR CHRONIC LOW BACK PAIN IN SERVICE MEMBERS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF AN INDIVIDUALIZED YOGA PROGRAM. DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: MILITARY MEDICAL CENTER. PARTICIPANTS: PATIENTS (N=68) WITH CHRONIC LOW BACK PAIN. INTERVENTIONS: RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE (RESTORE) PROGRAM (9-12 INDIVIDUAL YOGA SESSIONS) OR TREATMENT AS USUAL (CONTROL) FOR AN 8-WEEK PERIOD. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS PAST 24-HOUR PAIN (DEFENSE & VETERANS PAIN RATING SCALE 2.0). SECONDARY OUTCOMES INCLUDED DISABILITY (ROLAND-MORRIS DISABILITY QUESTIONNAIRE) AND PHYSICAL FUNCTIONING AND SYMPTOM BURDEN (PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-29 SUBSCALES). ASSESSMENT OCCURRED AT BASELINE, WEEK 4, WEEK 8, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. EXPLORATORY OUTCOMES INCLUDED THE PROPORTION OF PARTICIPANTS IN EACH GROUP REPORTING CLINICALLY MEANINGFUL CHANGES AT 3- AND 6-MONTH FOLLOW-UPS. RESULTS: GENERALIZED LINEAR MIXED MODELS WITH SEQUENTIAL BONFERRONI-ADJUSTED PAIRWISE SIGNIFICANCE TESTS AND CHI-SQUARE ANALYSES EXAMINED LONGITUDINAL OUTCOMES. SECONDARY OUTCOME SIGNIFICANCE TESTS WERE BONFERRONI ADJUSTED FOR MULTIPLE OUTCOMES. THE RESTORE GROUP REPORTED IMPROVED PAIN COMPARED WITH THE CONTROL GROUP. SECONDARY OUTCOMES DID NOT RETAIN SIGNIFICANCE AFTER BONFERRONI ADJUSTMENTS FOR MULTIPLE OUTCOMES, ALTHOUGH A HIGHER PROPORTION OF RESTORE PARTICIPANTS REPORTED CLINICALLY MEANINGFULLY CHANGES IN ALL OUTCOMES AT 3-MONTH FOLLOW-UP AND IN SYMPTOM BURDEN AT 6-MONTH FOLLOW-UP. CONCLUSIONS: RESTORE MAY BE A VIABLE NONPHARMACOLOGICAL TREATMENT FOR LOW BACK PAIN WITH MINIMAL SIDE EFFECTS, AND RESEARCH EFFORTS ARE NEEDED TO COMPARE THE EFFECTIVENESS OF RESTORE DELIVERY FORMATS (EG, GROUP VS INDIVIDUAL) WITH THAT OF OTHER TREATMENT MODALITIES.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
14 2843  26 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
15 1617  40 MINDFUL YOGA FOR WOMEN WITH METASTATIC BREAST CANCER: DESIGN OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: WOMEN WITH METASTATIC BREAST CANCER (MBC) HAVE AVERAGE LIFE EXPECTANCIES OF ABOUT 2 YEARS, AND REPORT HIGH LEVELS OF DISEASE-RELATED SYMPTOMS INCLUDING PAIN, FATIGUE, SLEEP DISTURBANCE, PSYCHOLOGICAL DISTRESS, AND FUNCTIONAL IMPAIRMENT. THERE IS GROWING RECOGNITION OF THE LIMITATIONS OF MEDICAL APPROACHES TO MANAGING SUCH SYMPTOMS. YOGA IS A MIND-BODY DISCIPLINE THAT HAS DEMONSTRATED A POSITIVE IMPACT ON PSYCHOLOGICAL AND FUNCTIONAL HEALTH IN EARLY STAGE BREAST CANCER PATIENTS AND SURVIVORS, BUT HAS NOT BEEN RIGOROUSLY STUDIED IN ADVANCED CANCER SAMPLES. METHODS: THIS RANDOMIZED CONTROLLED TRIAL EXAMINES THE FEASIBILITY AND INITIAL EFFICACY OF A MINDFUL YOGA PROGRAM, COMPARED WITH A SOCIAL SUPPORT CONDITION THAT CONTROLS FOR ATTENTION, ON MEASURES OF DISEASE-RELATED SYMPTOMS SUCH AS PAIN AND FATIGUE. THE STUDY WILL BE COMPLETED BY DECEMBER 2017. SIXTY-FIVE WOMEN WITH MBC AGE >/= 18 ARE BEING IDENTIFIED AND RANDOMIZED WITH A 2:1 ALLOCATION TO MINDFUL YOGA OR A SUPPORT GROUP CONTROL INTERVENTION. THE 120-MIN INTERVENTION SESSIONS TAKE PLACE WEEKLY FOR 8 WEEKS. THE STUDY IS CONDUCTED AT AN URBAN TERTIARY CARE ACADEMIC MEDICAL CENTER LOCATED IN DURHAM, NORTH CAROLINA. THE PRIMARY FEASIBILITY OUTCOME IS ATTENDANCE AT INTERVENTION SESSIONS. EFFICACY OUTCOMES INCLUDE PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS AND FUNCTIONAL CAPACITY AT POST-INTERVENTION, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. DISCUSSION: IN THIS ARTICLE, WE PRESENT THE CHALLENGES OF DESIGNING A RANDOMIZED CONTROLLED TRIAL WITH LONG-TERM FOLLOW-UP AMONG WOMEN WITH MBC. THESE CHALLENGES INCLUDE ENSURING ADEQUATE RECRUITMENT INCLUDING OF MINORITIES, LIMITING AND CONTROLLING FOR SELECTION BIAS, TAILORING OF THE YOGA INTERVENTION TO ADDRESS SPECIAL NEEDS, AND MAXIMIZING ADHERENCE AND RETENTION. THIS PROJECT WILL PROVIDE IMPORTANT INFORMATION REGARDING YOGA AS AN INTERVENTION FOR WOMEN WITH ADVANCED CANCER, INCLUDING PRELIMINARY DATA ON THE PSYCHOLOGICAL AND FUNCTIONAL EFFECTS OF YOGA FOR MBC PATIENTS. THIS INVESTIGATION WILL ALSO ESTABLISH RIGOROUS METHODS FOR FUTURE RESEARCH INTO YOGA AS AN INTERVENTION FOR THIS POPULATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFER: NCT01927081 , REGISTERED AUGUST 16, 2013.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
16 2360  30 VIDEOCONFERENCED YOGA INTERVENTIONS FOR CANCER PATIENTS AND THEIR CAREGIVERS DURING THE COVID-19 PANDEMIC: A REPORT FROM A CLINICIAN'S PERSPECTIVE. BACKGROUND: THE ACCEPTABILITY OF VIDEOCONFERENCING DELIVERY OF YOGA INTERVENTIONS IN THE ADVANCED CANCER SETTING IS RELATIVELY UNEXPLORED. THE CURRENT REPORT SUMMARIZES THE CHALLENGES AND SOLUTIONS OF THE TRANSITION FROM AN IN-PERSON (IE, FACE-TO-FACE) TO A VIDEOCONFERENCE INTERVENTION DELIVERY APPROACH IN RESPONSE TO THE CORONAVIRUS DISEASE PANDEMIC. METHOD: PARTICIPANTS INCLUDED PATIENT-FAMILY CAREGIVER DYADS WHO WERE ENROLLED IN ONGOING YOGA TRIALS AND 2 CERTIFIED YOGA THERAPISTS WHO DELIVERED THE YOGA SESSIONS. WE SUMMARIZED THEIR EXPERIENCES USING RECORDINGS OF THE YOGA SESSIONS AND INTERVENTIONISTS' PROGRESS NOTES. RESULTS: OUT OF 7 DYADS PARTICIPATING IN THE PARENT TRIAL, 1 DECLINED THE VIDEOCONFERENCED SESSIONS. PARTICIPANTS WERE BETWEEN THE AGES OF 55 AND 76 AND MOSTLY NON-HISPANIC WHITE (83%). PATIENTS WERE MAINLY MALE (83%), ALL HAD STAGE III OR IV CANCER AND WERE UNDERGOING RADIOTHERAPY. CAREGIVERS WERE ALL FEMALE. DESPITE CHALLENGES IN THE AREAS OF TECHNOLOGY, LOCATION, AND SETTING, INSTRUCTION AND PERSONAL CONNECTION, THE OVERALL ACCEPTABILITY WAS HIGH AMONG PATIENTS, CAREGIVERS, AND INSTRUCTORS. THROUGH THIS TRANSITION PROCESS, SOLUTIONS TO THESE CHALLENGES WERE FOUND, WHICH ARE DESCRIBED HERE. CONCLUSION: ALTHOUGH IN-PERSON INTERVENTIONS ARE FAVORED BY BOTH THE STUDY PARTICIPANTS AND THE INTERVENTIONISTS, VIDEOCONFERENCE SESSIONS WERE DEEMED ACCEPTABLE. ALL PARTICIPANTS HAD THE BENEFIT OF A PREVIOUS IN-PERSON EXPERIENCE, WHICH WAS HELPFUL AND PERHAPS NECESSARY FOR OLDER AND ADVANCED CANCER PATIENTS REQUIRING PRACTICE MODIFICATIONS. IN A REMOTE SETTING, THE ASSISTANCE OF CAREGIVERS SEEMS PARTICULARLY BENEFICIAL TO ENSURE PRACTICE SAFETY. CLINICALTRIALS.GOV: NCT03948100; NCT02481349.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
17 2763  37 YOGA PROGRAM FOR TYPE 2 DIABETES PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE: QUALITATIVE STUDY TO EXPLORE REASONS FOR NON-PARTICIPATION IN A FEASIBILITY RANDOMIZED CONTROLLED TRIAL IN INDIA. BACKGROUND: YOGA-BASED INTERVENTIONS CAN BE EFFECTIVE IN PREVENTING TYPE 2 DIABETES MELLITUS (T2DM). WE DEVELOPED A YOGA PROGRAM FOR T2DM PREVENTION (YOGA-DP) AMONG HIGH-RISK PEOPLE AND CONDUCTED A FEASIBILITY RANDOMIZED CONTROLLED TRIAL (RCT) IN INDIA. THE OBJECTIVE OF THIS STUDY WAS TO IDENTIFY AND EXPLORE WHY POTENTIAL PARTICIPANTS DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT. METHODS: AN EXPLORATORY QUALITATIVE STUDY, USING SEMI-STRUCTURED INTERVIEWS, WAS CONDUCTED AT A YOGA CENTER IN NEW DELHI, INDIA. FOURTEEN PEOPLE (10 WOMEN AND FOUR MEN) WHO DECLINED TO PARTICIPATE IN THE FEASIBILITY RCT WERE INTERVIEWED, AND 13 OF THEM COMPLETED THE NON-PARTICIPANT QUESTIONNAIRE, WHICH CAPTURED THEIR SOCIO-DEMOGRAPHICS, DIETS, PHYSICAL ACTIVITIES, AND REASONS FOR DECLINING. RESULTS: THREE TYPES OF BARRIERS WERE IDENTIFIED AND EXPLORED WHICH PREVENTED PARTICIPATION IN THE FEASIBILITY RCT: (1) PERSONAL BARRIERS, SUCH AS LACK OF TIME, PERCEIVED SUFFICIENCY OF KNOWLEDGE, PREFERENCES ABOUT SELF-MANAGEMENT OF HEALTH, AND TRUST IN OTHER TRADITIONAL AND ALTERNATIVE THERAPIES; (2) CONTEXTUAL BARRIERS, SUCH AS SOCIAL INFLUENCES AND LACK OF AWARENESS ABOUT PREVENTIVE CARE; AND (3) STUDY-RELATED BARRIERS, SUCH AS LACK OF STUDY INFORMATION, POOR ACCESSIBILITY TO THE YOGA SITE, AND LACK OF TRUST IN THE STUDY METHODS AND INTERVENTION. CONCLUSIONS: WE IDENTIFIED AND EXPLORED PERSONAL, CONTEXTUAL, AND STUDY-RELATED BARRIERS TO PARTICIPATION IN A FEASIBILITY RCT IN INDIA. THE FINDINGS WILL HELP TO ADDRESS RECRUITMENT CHALLENGES IN FUTURE YOGA AND OTHER RCTS. CLINICAL TRIAL REGISTRATION:WWW.CLINICALTRIALS.GOV, IDENTIFIER: CTRI/2019/05/018893.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
18 2831  32 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
19  566  40 DANCE AND YOGA REDUCED FUNCTIONAL ABDOMINAL PAIN IN YOUNG GIRLS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: FUNCTIONAL ABDOMINAL PAIN DISORDERS (FAPDS) AFFECT CHILDREN, ESPECIALLY GIRLS, ALL OVER THE WORLD. THE EVIDENCE FOR EXISTING TREATMENTS IS MIXED, AND EFFECTIVE ACCESSIBLE TREATMENTS ARE NEEDED. DANCE, A RHYTHMIC CARDIO-RESPIRATORY ACTIVITY, COMBINED WITH YOGA, WHICH ENHANCES RELAXATION AND FOCUS, MAY PROVIDE PHYSIOLOGICAL AND PSYCHOLOGICAL BENEFITS THAT COULD HELP TO EASE PAIN. OBJECTIVES: THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF A DANCE AND YOGA INTERVENTION ON MAXIMUM ABDOMINAL PAIN IN 9- TO 13-YEAR- OLD GIRLS WITH FAPDS. METHODS: THIS STUDY WAS A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL WITH 121 PARTICIPANTS RECRUITED FROM OUTPATIENT CLINICS AS WELL AS THE GENERAL PUBLIC. THE INTERVENTION GROUP PARTICIPATED IN DANCE AND YOGA TWICE WEEKLY FOR 8 MONTHS; CONTROLS RECEIVED STANDARD CARE. ABDOMINAL PAIN, AS SCORED ON THE FACES PAIN SCALE-REVISED, WAS RECORDED IN A PAIN DIARY. A LINEAR MIXED MODEL WAS USED TO ESTIMATE THE OUTCOMES AND EFFECT SIZES. RESULTS: DANCE AND YOGA WERE SUPERIOR TO STANDARD HEALTH CARE ALONE, WITH A MEDIUM TO HIGH BETWEEN-GROUP EFFECT SIZE AND SIGNIFICANTLY GREATER PAIN REDUCTION (B = -1.29, P = 0.002) AT THE END OF THE INTERVENTION. CONCLUSIONS: AN INTERVENTION USING DANCE AND YOGA IS LIKELY A FEASIBLE AND BENEFICIAL COMPLEMENTARY TREATMENT TO STANDARD HEALTH CARE FOR 9- TO 13-YEAR-OLD GIRLS WITH FAPDS. SIGNIFICANCE: FAPDS AFFECT CHILDREN, ESPECIALLY GIRLS, ALL OVER THE WORLD. THE NEGATIVE CONSEQUENCES SUCH AS ABSENCE FROM SCHOOL, HIGH CONSUMPTION OF MEDICAL CARE AND DEPRESSION POSE A CONSIDERABLE BURDEN ON CHILDREN AND THEIR FAMILIES AND EFFECTIVE TREATMENTS ARE NEEDED. THIS IS THE FIRST STUDY EXAMINING A COMBINED DANCE/YOGA INTERVENTION FOR YOUNG GIRLS WITH FAPDS AND THE RESULT SHOWED A REDUCTION OF ABDOMINAL PAIN. THESE FINDINGS CONTRIBUTE WITH NEW EVIDENCE IN THE FIELD OF MANAGING FAPDS IN A VULNERABLE TARGET GROUP.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
20 1331  37 HOME-BASED YOGA PROGRAM FOR THE PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA DURING CHEMOTHERAPY: A FEASIBILITY STUDY. BACKGROUND: YOGA IS PROVEN BENEFICIAL IN IMPROVING QUALITY OF LIFE AMONG BREAST CANCER SURVIVORS RECEIVING CHEMOTHERAPY, BUT ITS EFFECTIVENESS IN LYMPHOMA PATIENTS NEEDS TO BE EXPLORED. AS CHEMOTHERAPY-INDUCED NEUTROPENIA IS VERY COMMON AMONG LYMPHOMA PATIENTS, THEY ARE MUCH PRONE TO INFECTIONS FROM THE ENVIRONMENT. FURTHERMORE, TRAINED YOGA INSTRUCTORS ARE NOT AVAILABLE IN EVERY SETTING, SO THERE IS A NEED TO DEVELOP HOME-BASED YOGA PROGRAM MODULES FOR LYMPHOMA PATIENTS RECEIVING CHEMOTHERAPY. AIM: THE AIM OF THE STUDY WAS TO EXPLORE THE FEASIBILITY AND SAFETY OF YOGIC EXERCISES AMONG LYMPHOMA PATIENTS DURING CHEMOTHERAPY. SUBJECTS AND METHODS: AN INTERVENTIONAL, SINGLE-ARM PREPOST DESIGN STUDY WAS CONDUCTED AT A TERTIARY HEALTH-CARE CENTER. PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA (18-65 YEARS) WITH EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS FROM 0 TO 2, PLANNED TO RECEIVE CHEMOTHERAPY WERE ADMINISTERED A HOME-BASED YOGA PROGRAM OVER A PERIOD OF 2 MONTHS FROM THE START OF CHEMOTHERAPY. THE PRIMARY OUTCOME VARIABLES WERE RETENTION RATE, ACCEPTANCE RATE, SAFETY, AND ADHERENCE. HEALTH-RELATED QUALITY OF LIFE (HRQOL), FATIGUE LEVEL, OVERALL SLEEP QUALITY, DEPRESSION, ANXIETY LEVEL, AND PAIN WERE ALSO ASSESSED. STATISTICAL ANALYSIS: DESCRIPTIVE STATISTICS WAS USED TO SEE THE FEASIBILITY AND ADHERENCE. THE PAIRED T-TEST WAS USED TO COMPARE VARIOUS PRE AND POSTINTERVENTION OUTCOME MEASURES. RESULTS: FOURTEEN PATIENTS (MEDIAN AGE: 36 YEARS, RANGE13-65 YEARS) OF MALIGNANT LYMPHOMA WERE ENROLLED IN THE STUDY. MALE-TO-FEMALE RATIO WAS 9:5. NON-HODGKIN'S LYMPHOMA PATIENTS CONSTITUTED 64%. THE RECRUITMENT RATE WAS 93%. FAVORABLE RETENTION (100%), ACCEPTABILITY (97%), ADHERENCE (78.6%), AND NO SERIOUS ADVERSE EVENTS FOLLOWING YOGA PRACTICE WERE REPORTED. IMPROVEMENT WAS ALSO FOUND IN HRQOL, FATIGUE, SLEEP, DEPRESSION, AND ANXIETY. HOWEVER, IT NEEDS FURTHER VALIDATION IN A RANDOMIZED STUDY. CONCLUSION: HOME-BASED YOGA PROGRAM IS SAFE AND FEASIBLE AMONG THE PATIENTS SUFFERING FROM MALIGNANT LYMPHOMA RECEIVING CHEMOTHERAPY.	2018