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 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	
                                                                                                                    
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  217  46 A STUDY PROTOCOL OF A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL OF AN ONLINE YOGA INTERVENTION FOR MOTHERS AFTER STILLBIRTH (THE MINDFUL HEALTH STUDY). BACKGROUND: IN THE USA, STILLBIRTH (IN UTERO FETAL DEATH >/=20 WEEKS GESTATION) IS A MAJOR PUBLIC HEALTH ISSUE. WOMEN WHO EXPERIENCE STILLBIRTH, COMPARED TO WOMEN WITH LIVE BIRTH, HAVE A NEARLY SEVENFOLD INCREASED RISK OF A POSITIVE SCREEN FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AND A FOURFOLD INCREASED RISK OF DEPRESSIVE SYMPTOMS. BECAUSE THE MAJORITY OF WOMEN WHO HAVE EXPERIENCED THE DEATH OF THEIR BABY BECOME PREGNANT WITHIN 12-18 MONTHS AND THE LACK OF INTERVENTION STUDIES CONDUCTED WITHIN THIS POPULATION, NOVEL APPROACHES TARGETING PHYSICAL AND MENTAL HEALTH, SPECIFIC TO THE NEEDS OF THIS POPULATION, ARE CRITICAL. EVIDENCE SUGGESTS THAT YOGA IS EFFICACIOUS, SAFE, ACCEPTABLE, AND COST-EFFECTIVE FOR IMPROVING MENTAL HEALTH IN A VARIETY OF POPULATIONS, INCLUDING PREGNANT AND POSTPARTUM WOMEN. TO DATE, THERE ARE NO KNOWN STUDIES EXAMINING ONLINE-STREAMING YOGA AS A STRATEGY TO HELP MOTHERS COPE WITH PTSD SYMPTOMS AFTER STILLBIRTH. METHODS: THE PRESENT STUDY IS A TWO-PHASE RANDOMIZED CONTROLLED TRIAL. PHASE 1 WILL INVOLVE (1) AN ITERATIVE DESIGN PROCESS TO DEVELOP THE ONLINE YOGA PRESCRIPTION FOR PHASE 2 AND (2) QUALITATIVE INTERVIEWS TO IDENTIFY CULTURAL BARRIERS TO RECRUITMENT IN NON-CAUCASIAN WOMEN (I.E., PREDOMINATELY HISPANIC AND/OR AFRICAN AMERICAN) WHO HAVE EXPERIENCED STILLBIRTH (N = 5). PHASE 2 IS A THREE-GROUP RANDOMIZED FEASIBILITY TRIAL WITH ASSESSMENTS AT BASELINE, AND AT 12 AND 20 WEEKS POST-INTERVENTION. NINETY WOMEN WHO HAVE EXPERIENCED A STILLBIRTH WITHIN 6 WEEKS TO 24 MONTHS WILL BE RANDOMIZED INTO ONE OF THE FOLLOWING THREE ARMS FOR 12 WEEKS: (1) INTERVENTION LOW DOSE (LD) = 60 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), (2) INTERVENTION MODERATE DOSE (MD) = 150 MIN/WEEK ONLINE-STREAMING YOGA (N = 30), OR (3) STRETCH AND TONE CONTROL (STC) GROUP = 60 MIN/WEEK OF STRETCHING/TONING EXERCISES (N = 30). DISCUSSION: THIS STUDY WILL EXPLORE THE FEASIBILITY AND ACCEPTABILITY OF A 12-WEEK, HOME-BASED, ONLINE-STREAMED YOGA INTERVENTION, WITH VARYING DOSES AMONG MOTHERS AFTER A STILLBIRTH. IF FEASIBLE, THE FINDINGS FROM THIS STUDY WILL INFORM A FULL-SCALE TRIAL TO DETERMINE THE EFFECTIVENESS OF HOME-BASED ONLINE-STREAMED YOGA TO IMPROVE PTSD. LONG-TERM, HEALTH CARE PROVIDERS COULD USE ONLINE YOGA AS A NON-PHARMACEUTICAL, INEXPENSIVE RESOURCE FOR STILLBIRTH AFTERCARE. TRIAL REGISTRATION: NCT02925481.	2018	
                                                                                                                                                              
5 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
6  945  39 EFFECTS OF A 12-WEEK YOGA VERSUS A 12-WEEK EDUCATIONAL FILM INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME AND RELATED OUTCOMES: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL. STUDY OBJECTIVES: TO ASSESS THE EFFECTS OF A YOGA VERSUS EDUCATIONAL FILM (EF) PROGRAM ON RESTLESS LEGS SYNDROME (RLS) SYMPTOMS AND RELATED OUTCOMES IN ADULTS WITH RLS. METHODS: FORTY-ONE COMMUNITY-DWELLING, AMBULATORY NONPREGNANT ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EF PROGRAM (N = 22). IN ADDITION TO ATTENDING CLASSES, ALL PARTICIPANTS COMPLETED PRACTICE/TREATMENT LOGS. YOGA GROUP PARTICIPANTS WERE ASKED TO PRACTICE AT HOME 30 MINUTES PER DAY ON NONCLASS DAYS; EF PARTICIPANTS WERE INSTRUCTED TO RECORD ANY RLS TREATMENTS USED ON THEIR DAILY LOGS. CORE OUTCOMES ASSESSED PRETREATMENT AND POSTTREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS STUDY GROUP SCALE (IRLS) AND RLS ORDINAL SCALE), SLEEP QUALITY, MOOD, PERCEIVED STRESS, AND QUALITY OF LIFE (QOL). RESULTS: THIRTY ADULTS (13 YOGA, 17 EF), AGED 24 TO 73 (MEAN = 50.4 +/- 2.4 YEARS), COMPLETED THE 12-WEEK STUDY (78% FEMALE, 80.5% WHITE). POST-INTERVENTION, BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN RLS SYMPTOMS AND SEVERITY, PERCEIVED STRESS, MOOD, AND QOL-MENTAL HEALTH (P </= .04). RELATIVE TO THE EF GROUP, YOGA PARTICIPANTS DEMONSTRATED SIGNIFICANTLY GREATER REDUCTIONS IN RLS SYMPTOMS AND SYMPTOM SEVERITY (P </= .01), AND GREATER IMPROVEMENTS IN PERCEIVED STRESS AND MOOD (P </= .04), AS WELL AS SLEEP QUALITY (P = .09); RLS SYMPTOMS DECREASED TO MINIMAL/MILD IN 77% OF YOGA GROUP PARTICIPANTS, WITH NONE SCORING IN THE SEVERE RANGE BY WEEK 12, VERSUS 24% AND 12%, RESPECTIVELY, IN EF PARTICIPANTS. IN THE YOGA GROUP, IRLS AND RLS SEVERITY SCORES DECLINED WITH INCREASING MINUTES OF HOMEWORK PRACTICE (R = .7, P = .009 AND R = .6, P = .03, RESPECTIVELY), SUGGESTING A POSSIBLE DOSE-RESPONSE RELATIONSHIP. CONCLUSIONS: FINDINGS OF THIS EXPLORATORY RCT SUGGEST THAT YOGA MAY BE EFFECTIVE IN REDUCING RLS SYMPTOMS AND SYMPTOM SEVERITY, DECREASING PERCEIVED STRESS, AND IMPROVING MOOD AND SLEEP IN ADULTS WITH RLS. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; TITLE: YOGA VS. EDUCATION FOR RESTLESS LEGS: A FEASIBILITY STUDY; IDENTIFIER: NCT03570515; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03570515.	2020	
                                                                                                                                                                                                                                                                                                                                         
7  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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
8  172  35 A RANDOMIZED CONTROLLED PILOT STUDY OF YOGA SKILLS TRAINING VERSUS AN ATTENTION CONTROL DELIVERED DURING CHEMOTHERAPY ADMINISTRATION. CONTEXT: IT IS IMPORTANT TO ADDRESS FATIGUE AND CO-OCCURRING SYMPTOMS DURING CHEMOTHERAPY TO PRESERVE QUALITY OF LIFE IN PATIENTS WITH GASTROINTESTINAL (GI) CANCER. OBJECTIVE: TO CONDUCT A RANDOMIZED CONTROLLED PILOT STUDY OF A YOGA SKILLS TRAINING (YST) INTERVENTION COMPARED TO AN ATTENTION CONTROL (AC) AMONG ADULTS DIAGNOSED WITH GI CANCER. METHODS: YST CONSISTED OF FOUR 30-MINUTE SESSIONS DELIVERED INDIVIDUALLY DURING CHEMOTHERAPY PLUS HOME PRACTICE. AC PROVIDED EMPATHIC ATTENTION PLUS HOME DIARIES. PATIENT-REPORTED (PROMIS T-SCORE) ASSESSMENTS OF FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND PSYCHOLOGICAL STRESS (PERCEIVED STRESS SCALE) WERE COLLECTED AT CHEMOTHERAPY VISITS: BASELINE, WEEK 8, WEEK 10 AND WEEK 14, AND ANALYZED USING A MIXED EFFECTS MODEL. INFLAMMATORY CYTOKINES WERE ASSESSED AT BASELINE AND WEEK 10. RESULTS: FORTY-FOUR OF 77 ADULTS APPROACHED AGREED TO PARTICIPATE (57%; YST N = 23; AC N = 21). PARTICIPANTS' MEAN AGE WAS 58 YEARS AND 48% WERE MEN. PARTICIPANTS RANDOMIZED TO YST REPORTED A LARGER DECLINE IN FATIGUE (-2.4 DIFFERENCE, D = 0.30) AND DEPRESSIVE SYMPTOMS (-2.5 DIFFERENCE, D = 0.30) THAN AC PARTICIPANTS FROM BASELINE TO WEEK 10 AND SLEEP DISTURBANCES AT WEEK 8 (-3.9 DIFFERENCE, D = 0.50). DIFFERENCES IN MAGNITUDE OF CHANGE IN SYMPTOMS WERE CONSISTENT WITH OR EXCEEDED A MINIMALLY IMPORTANT DIFFERENCE. PSYCHOLOGICAL STRESS DECREASED MORE IN THE AC AT WEEK 10 (D = 0.30). REDUCTIONS IN INFLAMMATORY CYTOKINES (IL-6, STNF R1) WERE LARGER IN THE YST GROUP THAN AC. CONCLUSION: YST SHOWED PROMISE FOR IMPROVING FATIGUE, DEPRESSIVE SYMPTOMS, SLEEP DISTURBANCES, AND INFLAMMATION. YST IS ALSO FEASIBLE AND REACHES PATIENTS UNDERREPRESENTED IN YOGA RESEARCH (I.E., GI CANCER, MEN), THUS WARRANTING FURTHER EXAMINATION.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
9   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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
10 2019  31 SYNCHRONOUS TELEHEALTH YOGA AND COGNITIVE PROCESSING GROUP THERAPIES FOR WOMEN VETERANS WITH POSTTRAUMATIC STRESS DISORDER: A MULTISITE RANDOMIZED CONTROLLED TRIAL ADAPTED FOR COVID-19. BACKGROUND: PROVIDING CARE OVER TELEHEALTH GREW SLOWLY UNTIL THE COVID-19 PANDEMIC. SINCE THE ONSET OF THE COVID-19 PANDEMIC, PROVIDING MENTAL HEALTH CARE WAS READILY ADAPTED TO VIRTUAL MEANS; HOWEVER, CLINICAL TRIAL RESEARCH IS NASCENT IN ADAPTING METHODS AND PROCEDURES TO THE VIRTUAL WORLD. METHODS: WE PRESENT PROTOCOL MODIFICATIONS TO PIVOT A MULTISITE RANDOMIZED CONTROLLED TRIAL STUDY, CONDUCTED AT SOUTHEASTERN AND PACIFIC NORTHWESTERN VETERANS AFFAIRS HEALTH CARE SYSTEMS, FROM BEING CONDUCTED IN-PERSON TO VIRTUALLY, FOLLOWING THE ONSET OF THE COVID-19 PANDEMIC. WE MEASURED OUTCOMES OF POSTTRAUMATIC STRESS DISORDER (PTSD) SYMPTOMS AND PSYCHOPHYSIOLOGICAL MARKERS OF STRESS AMONG FEMALE VETERANS WITH PTSD SECONDARY TO MILITARY SEXUAL TRAUMA. WE COLLECTED QUALITATIVE DATA ABOUT PROVIDER AND PARTICIPANT EXPERIENCES WITH TELEHEALTH. RESULTS: ACROSS SITES, 200 PARTICIPANTS WERE CONSENTED (48 VIRTUALLY), 132 WERE RANDOMIZED (28 TO VIRTUAL GROUPS), AND 117 COMPLETED DATA COLLECTION AND TREATMENT (69 COMPLETED ALL OR SOME DATA COLLECTION OR TREATMENT VIRTUALLY). CONCLUSIONS: THE PIVOTS MADE FOR THIS STUDY WERE IN RESPONSE TO THE COVID-19 PANDEMIC AND OFFER INNOVATIVE PROCEDURES LEVERAGING TECHNOLOGY AND CONTRIBUTING TO THE BROADER LANDSCAPE OF CONDUCTING RESEARCH VIRTUALLY. CLINICAL TRIALS NUMBER: NCT02640690.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
11 2557  37 YOGA FOR CHRONIC CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY PAIN: A PILOT, RANDOMIZED CONTROLLED TRIAL. PURPOSE: TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A YOGA INTERVENTION FOR CANCER SURVIVORS WITH CHRONIC CIPN PAIN, AS WELL AS THE IMPACT OF THE INTERVENTION ON PATIENT-REPORTED OUTCOMES. METHODS: CANCER SURVIVORS WITH CHRONIC CIPN PAIN WERE RECRUITED FROM THE BREAST, GASTROINTESTINAL, AND GYNECOLOGICAL ONCOLOGY CENTERS AT DANA-FARBER CANCER INSTITUTE. PARTICIPANTS WERE RANDOMIZED (2:1) TO RECEIVE AN 8-WEEK YOGA INTERVENTION OR USUAL CARE. AFTER 21/50 OF PARTICIPANTS WERE ENROLLED, THE COVID-19 PANDEMIC REQUIRED THE YOGA INTERVENTION TO BE DELIVERED VIRTUALLY (I.E., ZOOM). PRE- AND POST-INTERVENTION, PARTICIPANTS SELF-REPORTED CIPN AND CO-OCCURRING SYMPTOM SEVERITY. ADHERENCE TO THE INTERVENTION WAS DEFINED AS PRACTICING >/= 12 YOGA SESSIONS OVER THE 8-WEEK INTERVENTION PERIOD. CHANGES IN PATIENT-REPORTED OUTCOMES BETWEEN GROUPS WERE COMPARED USING WILCOXON'S RANK-SUM TESTS. RESULTS: PARTICIPANTS (N = 28 YOGA, N = 16 CONTROL) WERE MAINLY FEMALE (96%) AND DIAGNOSED WITH STAGE III/IV DISEASE (66%). OVERALL, 19/28 (67.8%) OF YOGA GROUP PARTICIPANTS WERE ADHERENT TO THE YOGA PROTOCOL. YOGA GROUP PARTICIPANTS EXPERIENCED SIGNIFICANT WITHIN-GROUP IMPROVEMENTS IN ALL PATIENT-REPORTED OUTCOMES, INCLUDING WORST CIPN PAIN (MEDIAN CHANGE = - 1.7, P < 0.0001) AND SENSORY CIPN (MEDIAN CHANGE = - 14.8, P < 0.0001), BUT ONLY IMPROVEMENTS IN FATIGUE (P = 0.05) AND DEPRESSION (P = 0.04) WERE SIGNIFICANT COMPARED TO THE CONTROL. THERE WERE NO DIFFERENCES (P > 0.05) IN CHANGES IN PATIENT-REPORTED OUTCOMES BETWEEN IN-PERSON (N = 6) OR VIRTUAL (N = 15) YOGA GROUP PARTICIPANTS. CONCLUSIONS: YOGA IS A FEASIBLE NON-PHARMACOLOGICAL MODALITY FOR CANCER SURVIVORS WITH CIPN, BUT MORE INFORMATION IS NEEDED REGARDING ITS IMPACT ON CIPN AND OTHER SYMPTOMS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT03824860 IMPLICATIONS FOR CANCER SURVIVORS: ONCOLOGY CLINICIANS MAY CONSIDER REFERRING CANCER SURVIVORS TO YOGA FOR CHRONIC CIPN PAIN, BUT YOGA CANNOT BE CURRENTLY RECOMMENDED AS AN EFFICACIOUS TREATMENT.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
12 1865  40 RANDOMIZED PILOT TRIAL OF YOGA VERSUS STRENGTHENING EXERCISES IN BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE. PURPOSE: FATIGUE IS ONE OF THE MOST COMMON AND BOTHERSOME REFRACTORY SYMPTOMS EXPERIENCED BY CANCER SURVIVORS. MINDFUL EXERCISE INTERVENTIONS SUCH AS YOGA IMPROVE CANCER-RELATED FATIGUE; HOWEVER, STUDIES OF YOGA HAVE INCLUDED HETEROGENEOUS SURVIVORSHIP POPULATIONS, AND THE EFFECT OF YOGA ON FATIGUED SURVIVORS REMAINS UNCLEAR. METHODS: WE RANDOMLY ASSIGNED 34 EARLY-STAGE BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE (>/=4 ON A LIKERT SCALE FROM 1-10) WITHIN 1 YEAR FROM DIAGNOSIS TO A 12-WEEK INTERVENTION OF HOME-BASED YOGA VERSUS STRENGTHENING EXERCISES, BOTH PRESENTED ON A DVD. THE PRIMARY ENDPOINTS WERE FEASIBILITY AND CHANGES IN FATIGUE, AS MEASURED BY THE MULTIDIMENSIONAL FATIGUE SYMPTOM INVENTORY-SHORT FORM (MFSI-SF). SECONDARY ENDPOINT WAS QUALITY OF LIFE, ASSESSED BY THE FUNCTIONAL ASSESSMENT OF CANCER THERAPIES-BREAST (FACT-B). RESULTS: WE INVITED 401 WOMEN TO PARTICIPATE IN THE STUDY; 78 RESPONDED, AND WE ENROLLED 34. BOTH GROUPS HAD SIGNIFICANT WITHIN-GROUP IMPROVEMENT IN MULTIPLE DOMAINS OF THE FATIGUE AND QUALITY OF LIFE SCORES FROM BASELINE TO POST-INTERVENTION, AND THESE BENEFITS WERE MAINTAINED AT 3 MONTHS POST-INTERVENTION. HOWEVER, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS IN FATIGUE OR QUALITY OF LIFE AT ANY ASSESSMENT TIME. SIMILARLY, THERE WAS NO DIFFERENCE BETWEEN GROUPS IN ADHERENCE TO THE EXERCISE INTERVENTION. CONCLUSIONS: BOTH DVD-BASED YOGA AND STRENGTHENING EXERCISES DESIGNED FOR CANCER SURVIVORS MAY BE GOOD OPTIONS TO ADDRESS FATIGUE IN BREAST CANCER SURVIVORS. BOTH HAVE REASONABLE UPTAKE, ARE CONVENIENT AND REPRODUCIBLE, AND MAY BE HELPFUL IN DECREASING FATIGUE AND IMPROVING QUALITY OF LIFE IN THE FIRST YEAR POST-DIAGNOSIS IN BREAST CANCER PATIENTS WITH CANCER-RELATED FATIGUE.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
13  312  39 AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL OF A 12-WEEK YOGA VERSUS EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME: FEASIBILITY AND ACCEPTABILITY. OBJECTIVES: THE PRIMARY OBJECTIVES OF THIS PILOT TRIAL WERE TO ASSESS THE STUDY FEASIBILITY AND ACCEPTABILITY OF THE 12-WEEK YOGA AND EDUCATIONAL FILM PROGRAMS FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS) IN PREPARATION FOR A FUTURE RANDOMIZED CONTROLLED TRIAL (RCT). MATERIALS AND METHODS: THIS PILOT, PARALLEL-ARM, RANDOMIZED FEASIBILITY TRIAL WAS CONDUCTED AT TWO SITES, MORGANTOWN, WV AND COLUMBUS, OH. YOGA GROUP PARTICIPANTS ATTENDED 75-MIN IYENGAR YOGA CLASSES, TWICE WEEKLY FOR 4 WEEKS, THEN ONCE A WEEK FOR 8 WEEKS (16 TOTAL CLASSES), AND COMPLETED A 30-MIN HOMEWORK ROUTINE ON NONCLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS ATTENDED ONCE WEEKLY, 75-MIN CLASSES (12 TOTAL CLASSES), WHICH INCLUDED INFORMATION ON RLS AND OTHER SLEEP DISORDERS, RLS MANAGEMENT INCLUDING SLEEP HYGIENE PRACTICES, AND COMPLEMENTARY THERAPIES. FEASIBILITY AND ACCEPTABILITY OUTCOMES INCLUDED PROGRAM SATISFACTION AND RECRUITMENT, RETENTION, AND ADHERENCE RATES. IN ADDITION, PARTICIPANTS WERE ASKED THEIR PREFERENCES REGARDING THREE YOGA CLASS SCHEDULE SCENARIOS FOR A FUTURE STUDY. ATTENDANCE, YOGA, AND TREATMENT LOGS WERE COLLECTED WEEKLY. PROGRAM EVALUATION AND YOGA SCHEDULING QUESTIONNAIRES WERE COLLECTED AT WEEK 12. RESULTS: FORTY-ONE ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EDUCATIONAL FILM (N = 22) PROGRAM. THIRTY PARTICIPANTS (73%) COMPLETED THE PROGRAM. YOGA AND EDUCATION GROUP PARTICIPANTS ATTENDED AN AVERAGE OF 13.0 +/- 0.84 (81%) AND 10.3 +/- 0.3 CLASSES (85%), RESPECTIVELY. PARTICIPANTS FROM BOTH GROUPS INDICATED SATISFACTION WITH THE STUDY. ALL YOGA GROUP RESPONDENTS TO THE PROGRAM EVALUATION REPORTED THEY WOULD LIKELY (N = 6) OR VERY LIKELY (N = 7) CONTINUE YOGA PRACTICE; 86.7% OF EDUCATION GROUP RESPONDENTS (13 OF 15) INDICATED THAT THEY WERE LIKELY (N = 7) OR VERY LIKELY (N = 6) TO MAKE LASTING CHANGES BASED ON WHAT THEY HAD LEARNED. THE PREFERRED SCHEDULE FOR A FUTURE STUDY WAS A 16-WEEK STUDY WITH ONCE-WEEKLY YOGA CLASSES. CONCLUSIONS: THE FINDINGS OF THIS STUDY SUGGEST THAT A LARGER RCT COMPARING YOGA WITH AN EDUCATIONAL FILM GROUP FOR THE MANAGEMENT OF RLS IS FEASIBLE. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT03570515; 02/01/2017.	2022	
                                                                                                                                                                                                                                                                                   
14 1240  38 FEASIBILITY OF A MINDFUL YOGA PROGRAM FOR WOMEN WITH METASTATIC BREAST CANCER: RESULTS OF A RANDOMIZED PILOT STUDY. PURPOSE: PATIENTS WITH METASTATIC BREAST CANCER (MBC) EXPERIENCE HIGH LEVELS OF SYMPTOMS. YOGA INTERVENTIONS HAVE SHOWN PROMISE FOR IMPROVING CANCER SYMPTOMS BUT HAVE RARELY BEEN TESTED IN PATIENTS WITH ADVANCED DISEASE. THIS STUDY EXAMINED THE ACCEPTABILITY OF A COMPREHENSIVE YOGA PROGRAM FOR MBC AND THE FEASIBILITY OF CONDUCTING A RANDOMIZED TRIAL TESTING THE INTERVENTION. METHODS: SIXTY-THREE WOMEN WITH MBC WERE RANDOMIZED WITH A 2:1 ALLOCATION TO YOGA OR A SUPPORT GROUP COMPARISON CONDITION. BOTH INTERVENTIONS INVOLVED EIGHT WEEKLY GROUP SESSIONS. FEASIBILITY WAS QUANTIFIED USING RATES OF ACCRUAL, ATTRITION, AND SESSION ATTENDANCE. ACCEPTABILITY WAS ASSESSED WITH A STANDARDIZED SELF-REPORT MEASURE. PAIN, FATIGUE, SLEEP QUALITY, PSYCHOLOGICAL DISTRESS, MINDFULNESS, AND FUNCTIONAL CAPACITY WERE ASSESSED AT BASELINE, POST-INTERVENTION, AND 3 AND 6 MONTHS POST-INTERVENTION. RESULTS: WE MET GOALS FOR ACCRUAL AND RETENTION, WITH 50% OF ELIGIBLE PATIENTS ENROLLED AND 87% OF RANDOMIZED PARTICIPANTS COMPLETING POST-INTERVENTION SURVEYS. SIXTY-FIVE PERCENT OF WOMEN IN THE YOGA CONDITION AND 90% IN THE SUPPORT GROUP ATTENDED >/= 4 SESSIONS. EIGHTY PERCENT OF PARTICIPANTS IN THE YOGA CONDITION AND 65% IN THE SUPPORT GROUP INDICATED THAT THEY WERE HIGHLY SATISFIED WITH THE INTERVENTION. FOLLOWING TREATMENT, WOMEN IN THE YOGA INTERVENTION HAD MODEST IMPROVEMENTS IN SOME OUTCOMES; HOWEVER, OVERALL SYMPTOM LEVELS WERE LOW FOR WOMEN IN BOTH CONDITIONS. CONCLUSIONS: FINDINGS SUGGEST THAT THE YOGA INTERVENTION CONTENT WAS HIGHLY ACCEPTABLE TO PATIENTS WITH MBC, BUT THAT THERE ARE CHALLENGES TO IMPLEMENTING AN INTERVENTION INVOLVING EIGHT GROUP-BASED IN-PERSON SESSIONS. ALTERNATIVE MODES OF DELIVERY MAY BE NECESSARY TO REACH PATIENTS MOST IN NEED OF INTERVENTION.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
15 1683  41 ONLINE YOGA TO REDUCE POST TRAUMATIC STRESS IN WOMEN WHO HAVE EXPERIENCED STILLBIRTH: A RANDOMIZED CONTROL FEASIBILITY TRIAL. BACKGROUND: ABOUT 1 IN EVERY 150 PREGNANCIES END IN STILLBIRTH. CONSEQUENCES INCLUDE SYMPTOMS OF POST TRAUMATIC STRESS DISORDER (PTSD), DEPRESSION, AND ANXIETY. YOGA HAS BEEN USED TO TREAT PTSD IN OTHER POPULATIONS AND MAY IMPROVE HEALTH OUTCOMES FOR STILLBIRTH MOTHERS. THE PURPOSE OF THIS STUDY WAS TO DETERMINE: (A) FEASIBILITY OF A 12-WEEK HOME-BASED, ONLINE YOGA INTERVENTION WITH VARYING DOSES; (B) ACCEPTABILITY OF A "STRETCH AND TONE" CONTROL GROUP; AND (C) PRELIMINARY EFFICACY OF THE INTERVENTION ON REDUCING SYMPTOMS OF PTSD, ANXIETY, DEPRESSION, PERINATAL GRIEF, SELF-COMPASSION, EMOTIONAL REGULATION, MINDFULNESS, SLEEP QUALITY, AND SUBJECTIVE HEALTH. METHODS: PARTICIPANTS (N = 90) WERE RECRUITED NATIONALLY AND RANDOMIZED INTO ONE OF THREE GROUPS FOR YOGA OR EXERCISE (LOW DOSE (LD), 60 MIN PER WEEK; MODERATE DOSE (MD), 150 MIN PER WEEK; AND STRETCH-AND-TONE CONTROL GROUP (STC)). BASELINE AND POST-INTERVENTION SURVEYS MEASURED MAIN OUTCOMES (LISTED ABOVE). FREQUENCY ANALYSES WERE USED TO DETERMINE FEASIBILITY. REPEATED MEASURES ANCOVA WERE USED TO DETERMINE PRELIMINARY EFFICACY. MULTIPLE REGRESSION ANALYSES WERE USED TO DETERMINE A DOSE-RESPONSE RELATIONSHIP BETWEEN MINUTES OF YOGA AND EACH OUTCOME VARIABLE. RESULTS: OVER HALF OF PARTICIPANTS COMPLETED THE INTERVENTION (N = 48/90). BENCHMARKS (>/=70% REPORTED > 75% SATISFACTION) WERE MET IN EACH GROUP FOR SATISFACTION AND ENJOYMENT. PARTICIPANTS MEETING BENCHMARKS (COMPLETING > 90% OF PRESCRIBED MINUTES 9/12 WEEKS) FOR LD AND MD GROUPS WERE 44% (N = 8/18) AND 6% (N = 1/16), RESPECTIVELY. LD AND MD GROUPS AVERAGED 44.0 AND 77.3 MIN PER WEEK OF YOGA, RESPECTIVELY. THE MD GROUP REPORTED THAT 150 PRESCRIBED MINUTES PER WEEK OF YOGA WAS TOO MUCH. THERE WERE SIGNIFICANT DECREASES IN PTSD AND DEPRESSION, AND IMPROVEMENTS IN SELF-RATED HEALTH AT POST-INTERVENTION FOR BOTH INTERVENTION GROUPS. THERE WAS A SIGNIFICANT DIFFERENCE IN DEPRESSION SCORES (P = .036) AND GRIEF INTENSITY (P = .009) BETWEEN THE MD AND STC GROUPS. PTSD SHOWED NON-SIGNIFICANT DECREASES OF 43% AND 56% AT POST-INTERVENTION IN LD AND MD GROUPS, RESPECTIVELY (22% DECREASE IN CONTROL). CONCLUSIONS: THIS WAS THE FIRST STUDY TO DETERMINE THE FEASIBILITY AND PRELIMINARY EFFICACY OF AN ONLINE YOGA INTERVENTION FOR WOMEN AFTER STILLBIRTH. FUTURE RESEARCH WARRANTS A RANDOMIZED CONTROLLED TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV. NCT02925481. REGISTERED 10-04-16.	2020	
                                                                                                                   
16  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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
17   70  38 A FEASIBILITY STUDY EXAMINING THE IMPACT OF YOGA ON PSYCHOSOCIAL HEALTH AND SYMPTOMS IN PEDIATRIC OUTPATIENTS RECEIVING CHEMOTHERAPY. PURPOSE: PEDIATRIC CANCER PATIENTS EXPERIENCE SYMPTOMS THAT NEGATIVELY IMPACT QUALITY OF LIFE; YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF A 10-WEEK, WEEKLY INDIVIDUALIZED YOGA INTERVENTION FOR CHILDREN AND ADOLESCENTS RECEIVING OUTPATIENT CANCER THERAPY PRIMARILY DELIVERED REMOTELY USING SKYPE. SECONDARY OBJECTIVES WERE TO DESCRIBE DEPRESSION, ANXIETY, ANGER, FATIGUE, QUALITY OF LIFE, AND SYMPTOMS AT 5 AND 10 WEEKS AFTER ENROLLMENT. METHODS: WE INCLUDED ENGLISH-SPEAKING PATIENTS AGED 10 TO 18 YEARS RECEIVING OUTPATIENT CHEMOTHERAPY FOR CANCER. WEEKLY INDIVIDUALIZED YOGA SESSIONS WERE OFFERED FOR 10 WEEKS. WEEKS 1, 5, AND 10 WERE IN-HOSPITAL WHILE THE REMAINING SESSIONS WERE DELIVERED REMOTELY USING SKYPE. TWICE WEEKLY, HOMEWORK WAS ASSIGNED BETWEEN EACH SESSION. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS 80% OF PARTICIPANTS COMPLETING AT LEAST 60% OF PLANNED IN-HOSPITAL OR REMOTE YOGA SESSIONS. RESULTS: BETWEEN MARCH AND NOVEMBER 2017, 10 PATIENTS WERE ENROLLED. TWO PATIENTS DISCONTINUED THE STUDY AFTER ONE AND TWO SESSIONS. ONLY SIX PARTICIPANTS ACHIEVED AT LEAST 60% OF PLANNED YOGA SESSIONS AND THUS, THE STUDY DID NOT MEET THE A PRIORI DEFINED FEASIBILITY THRESHOLD. AMONG ALL PARTICIPANTS, ONLY ONE HOMEWORK SESSION WAS PERFORMED. CONCLUSIONS: A 10-WEEK INDIVIDUALIZED IN-PERSON AND REMOTELY CONDUCTED YOGA INTERVENTION WAS NOT FEASIBLE IN CHILDREN RECEIVING CANCER TREATMENTS BECAUSE OF FAILURE TO ACHIEVE THE DESIRED FREQUENCY OF YOGA SESSIONS IN A SUFFICIENT NUMBER OF PARTICIPANTS. FUTURE RESEARCH SHOULD IDENTIFY APPROACHES TO IMPROVE COMPLIANCE WITH REMOTE YOGA SESSIONS AND HOME PRACTICE. TRIAL REGISTRATION: NCT03318068.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
18 1862  35 RANDOMIZED CONTROLLED TRIAL OF YOGA AMONG A MULTIETHNIC SAMPLE OF BREAST CANCER PATIENTS: EFFECTS ON QUALITY OF LIFE. PURPOSE: THIS STUDY EXAMINES THE IMPACT OF YOGA, INCLUDING PHYSICAL POSES, BREATHING, AND MEDITATION EXERCISES, ON QUALITY OF LIFE (QOL), FATIGUE, DISTRESSED MOOD, AND SPIRITUAL WELL-BEING AMONG A MULTIETHNIC SAMPLE OF BREAST CANCER PATIENTS. PATIENTS AND METHODS: ONE HUNDRED TWENTY-EIGHT PATIENTS (42% AFRICAN AMERICAN, 31% HISPANIC) RECRUITED FROM AN URBAN CANCER CENTER WERE RANDOMLY ASSIGNED (2:1 RATIO) TO A 12-WEEK YOGA INTERVENTION (N = 84) OR A 12-WEEK WAITLIST CONTROL GROUP (N = 44). CHANGES IN QOL (EG, FUNCTIONAL ASSESSMENT OF CANCER THERAPY) FROM BEFORE RANDOM ASSIGNMENT (T1) TO THE 3-MONTH FOLLOW-UP (T3) WERE EXAMINED; PREDICTORS OF ADHERENCE WERE ALSO ASSESSED. NEARLY HALF OF ALL PATIENTS WERE RECEIVING MEDICAL TREATMENT. RESULTS: REGRESSION ANALYSES INDICATED THAT THE CONTROL GROUP HAD A GREATER DECREASE IN SOCIAL WELL-BEING COMPARED WITH THE INTERVENTION GROUP AFTER CONTROLLING FOR BASELINE SOCIAL WELL-BEING AND COVARIATES (P < .0001). SECONDARY ANALYSES OF 71 PATIENTS NOT RECEIVING CHEMOTHERAPY DURING THE INTERVENTION PERIOD INDICATED FAVORABLE OUTCOMES FOR THE INTERVENTION GROUP COMPARED WITH THE CONTROL GROUP IN OVERALL QOL (P < .008), EMOTIONAL WELL-BEING (P < .015), SOCIAL WELL-BEING (P < .004), SPIRITUAL WELL-BEING (P < .009), AND DISTRESSED MOOD (P < .031). SIXTY-NINE PERCENT OF INTERVENTION PARTICIPANTS ATTENDED CLASSES (MEAN NUMBER OF CLASSES ATTENDED BY ACTIVE CLASS PARTICIPANTS = 7.00 +/- 3.80), WITH LOWER ADHERENCE ASSOCIATED WITH INCREASED FATIGUE (P < .001), RADIOTHERAPY (P < .0001), YOUNGER AGE (P < .008), AND NO ANTIESTROGEN THERAPY (P < .02). CONCLUSION: DESPITE LIMITED ADHERENCE, THIS INTENT-TO-TREAT ANALYSIS SUGGESTS THAT YOGA IS ASSOCIATED WITH BENEFICIAL EFFECTS ON SOCIAL FUNCTIONING AMONG A MEDICALLY DIVERSE SAMPLE OF BREAST CANCER SURVIVORS. AMONG PATIENTS NOT RECEIVING CHEMOTHERAPY, YOGA APPEARS TO ENHANCE EMOTIONAL WELL-BEING AND MOOD AND MAY SERVE TO BUFFER DETERIORATION IN BOTH OVERALL AND SPECIFIC DOMAINS OF QOL.	2007	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
19 2604  40 YOGA FOR PERSISTENT FATIGUE IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CANCER-RELATED FATIGUE AFFLICTS UP TO 33% OF BREAST CANCER SURVIVORS, YET THERE ARE NO EMPIRICALLY VALIDATED TREATMENTS FOR THIS SYMPTOM. METHODS: THE AUTHORS CONDUCTED A 2-GROUP RANDOMIZED CONTROLLED TRIAL TO DETERMINE THE FEASIBILITY AND EFFICACY OF AN IYENGAR YOGA INTERVENTION FOR BREAST CANCER SURVIVORS WITH PERSISTENT POST-TREATMENT FATIGUE. PARTICIPANTS WERE BREAST CANCER SURVIVORS WHO HAD COMPLETED CANCER TREATMENTS (OTHER THAN ENDOCRINE THERAPY) AT LEAST 6 MONTHS BEFORE ENROLLMENT, REPORTED SIGNIFICANT CANCER-RELATED FATIGUE, AND HAD NO OTHER MEDICAL CONDITIONS THAT WOULD ACCOUNT FOR FATIGUE SYMPTOMS OR INTERFERE WITH YOGA PRACTICE. BLOCK RANDOMIZATION WAS USED TO ASSIGN PARTICIPANTS TO A 12-WEEK, IYENGAR-BASED YOGA INTERVENTION OR TO 12 WEEKS OF HEALTH EDUCATION (CONTROL). THE PRIMARY OUTCOME WAS CHANGE IN FATIGUE MEASURED AT BASELINE, IMMEDIATELY POST-TREATMENT, AND 3 MONTHS AFTER TREATMENT COMPLETION. ADDITIONAL OUTCOMES INCLUDED CHANGES IN VIGOR, DEPRESSIVE SYMPTOMS, SLEEP, PERCEIVED STRESS, AND PHYSICAL PERFORMANCE. INTENT-TO-TREAT ANALYSES WERE CONDUCTED WITH ALL RANDOMIZED PARTICIPANTS USING LINEAR MIXED MODELS. RESULTS: THIRTY-ONE WOMEN WERE RANDOMLY ASSIGNED TO YOGA (N = 16) OR HEALTH EDUCATION (N = 15). FATIGUE SEVERITY DECLINED SIGNIFICANTLY FROM BASELINE TO POST-TREATMENT AND OVER A 3-MONTH FOLLOW-UP IN THE YOGA GROUP RELATIVE TO CONTROLS (P = .032). IN ADDITION, THE YOGA GROUP HAD SIGNIFICANT INCREASES IN VIGOR RELATIVE TO CONTROLS (P = .011). BOTH GROUPS HAD POSITIVE CHANGES IN DEPRESSIVE SYMPTOMS AND PERCEIVED STRESS (P < .05). NO SIGNIFICANT CHANGES IN SLEEP OR PHYSICAL PERFORMANCE WERE OBSERVED. CONCLUSIONS: A TARGETED YOGA INTERVENTION LED TO SIGNIFICANT IMPROVEMENTS IN FATIGUE AND VIGOR AMONG BREAST CANCER SURVIVORS WITH PERSISTENT FATIGUE SYMPTOMS.	2012	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
20  201  40 A RESTORATIVE YOGA INTERVENTION FOR AFRICAN-AMERICAN BREAST CANCER SURVIVORS: A PILOT STUDY. BACKGROUND: DATA SHOW THAT YOGA IS EFFECTIVE FOR IMPROVING HEALTH-RELATED OUTCOMES IN BREAST CANCER SURVIVORS. WHILE BREAST CANCER IS THE MOST COMMONLY DIAGNOSED CANCER AMONG AFRICAN-AMERICAN WOMEN (AAW), AAW ARE LESS LIKELY TO ENGAGE IN YOGA COMPARED TO OTHER ETHNIC GROUPS. THE GOALS OF THE CURRENT STUDY WERE TO ASSESS THE FEASIBILITY OF AN 8-WEEK RESTORATIVE YOGA PROGRAM AMONG AFRICAN-AMERICAN BREAST CANCER SURVIVORS (AA BCS). SPECIFICALLY, STUDY AIMS WERE TO (1) MEASURE CHANGES IN STUDY OUTCOMES IN A RESTORATIVE YOGA (RY) GROUP COMPARED TO A WAIT LIST CONTROL GROUP, (2) ASSESS ADHERENCE TO THE RY PROGRAM, AND (3) ASSESS PROGRAM SATISFACTION AMONG STUDY PARTICIPANTS. METHODS: THIRTY-THREE AA BCS WERE RANDOMLY ASSIGNED TO EITHER THE RY INTERVENTION (N = 18) OR WAIT LIST CONTROL GROUP (N = 15). RY CLASSES MET ONCE PER WEEK FOR 8 WEEKS. PRE- AND POST-TESTING ASSESSMENTS WERE MEASURED AT 0 AND 8 WEEKS (IMMEDIATELY POST-INTERVENTION). RESULTS: DEPRESSION SCORES AT FOLLOW-UP WERE SIGNIFICANTLY LOWER IN THE YOGA GROUP (M = 4.78, SD = 3.56) COMPARED TO THE CONTROL GROUP (M = 6.91, SD = 5.86). NO SIGNIFICANT GROUP DIFFERENCES WERE OBSERVED FOR SLEEP QUALITY, FATIGUE, OR PERCEIVED STRESS. YOGA PROGRAM PARTICIPANTS COMPLETING BASELINE ASSESSMENTS DEMONSTRATED 61% ADHERENCE TO THE YOGA CLASSES. AVERAGE RATING OF THE YOGA PROGRAM WAS "VERY USEFUL." RECOMMENDATIONS FOR FUTURE YOGA PROGRAMS WERE PROVIDED. CONCLUSIONS: THIS STUDY SUGGESTS THAT YOGA HAS A BENEFICIAL EFFECT ON DEPRESSION IN AA BCS. THERE IS, HOWEVER, A NEED TO FURTHER EXPLORE THE BENEFITS OF YOGA AMONG MINORITY BREAST CANCER SURVIVORS USING A STUDY WITH LARGER SAMPLE SIZES.	2018