1  551 162 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
2  199  36 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  43 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   41  48 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
5 1224  49 FEASIBILITY AND ASSESSMENT OF OUTCOME MEASURES FOR YOGA AS SELF-CARE FOR MINORITIES WITH ARTHRITIS: A PILOT STUDY. BACKGROUND: WHILE THERE IS A GROWING INTEREST IN THE THERAPEUTIC BENEFITS OF YOGA, MINORITY POPULATIONS WITH ARTHRITIS TEND TO BE UNDER-REPRESENTED IN THE RESEARCH. ADDITIONALLY, THERE IS AN ABSENCE OF GUIDANCE IN THE LITERATURE REGARDING THE USE OF MULTICULTURAL TEAMS AND SOCIOCULTURAL HEALTH BELIEFS, WHEN DESIGNING YOGA STUDIES FOR A RACIALLY DIVERSE POPULATION WITH ARTHRITIS. THIS PILOT STUDY EXAMINED THE FEASIBILITY OF OFFERING YOGA AS A SELF-CARE MODALITY TO AN URBAN, BILINGUAL, MINORITY POPULATION WITH OSTEOARTHRITIS (OA) OR RHEUMATOID ARTHRITIS (RA), IN THE WASHINGTON, DC AREA. METHODS: THE PRIMARY OBJECTIVE OF THE STUDY WAS TO ASSESS THE FEASIBILITY OF OFFERING AN 8-WEEK, BILINGUAL YOGA INTERVENTION ADAPTED FOR ARTHRITIS TO A CONVENIENCE SAMPLE OF PRIMARILY HISPANIC AND BLACK/AFRICAN-AMERICAN ADULTS. A RACIALLY DIVERSE INTERDISCIPLINARY RESEARCH TEAM WAS ASSEMBLED TO DESIGN A STUDY TO FACILITATE RECRUITMENT AND RETENTION. THE SECOND OBJECTIVE IDENTIFIED OUTCOME MEASURES TO OPERATIONALIZE POTENTIAL FACILITATORS AND BARRIERS TO SELF-CARE AND SELF-EFFICACY. THE THIRD OBJECTIVE DETERMINED THE FEASIBILITY OF USING COMPUTER-ASSISTED SELF-INTERVIEW (CASI) FOR DATA COLLECTION. RESULTS: ENROLLED PARTICIPANTS (N = 30) WERE MOSTLY FEMALE (93%), SPANISH SPEAKING (69%), AND DIAGNOSED WITH RA (88.5%). FEASIBILITY WAS EVALUATED USING PRACTICALITY, ACCEPTABILITY, ADAPTATION, AND EXPANSION OF AN ARTHRITIS-ADAPTED YOGA INTERVENTION, MODIFIED FOR THIS POPULATION. RECRUITMENT (51%) AND PARTICIPATION (60%) RATES WERE SIMILAR TO PREVIOUS RESEARCH AND CLINICAL EXPERIENCE WITH THE STUDY POPULATION. OF THOSE ENROLLED, 18 STARTED THE INTERVENTION. FOR ADHERENCE, 12 OUT OF 18 (67%) PARTICIPANTS COMPLETED THE INTERVENTION. ALL (100%), WHO COMPLETED THE INTERVENTION, CONTINUED TO PRACTICE YOGA 3 MONTHS AFTER COMPLETING THE STUDY. USING NONPARAMETRIC TESTS, SELECTED OUTCOME MEASURES SHOWED A MEASURABLE CHANGE POST-INTERVENTION SUGGESTING APPROPRIATE USE IN FUTURE STUDIES. AN IN-PERSON COMPUTERIZED QUESTIONNAIRE WAS DETERMINED TO BE A FEASIBLE METHOD OF DATA COLLECTION. CONCLUSIONS: FINDINGS FROM THIS PILOT STUDY CONFIRM THE FEASIBILITY OF OFFERING YOGA TO THIS RACIALLY/ETHNICALLY DIVERSE POPULATION WITH ARTHRITIS. THIS ARTICLE PROVIDES RECRUITMENT/RETENTION RATES, OUTCOME MEASURES WITH ERROR RATES, AND DATA COLLECTION RECOMMENDATIONS FOR A PREVIOUSLY UNDER-REPRESENTED POPULATION. SUGGESTIONS INCLUDE ALLOCATING RESOURCES FOR TRANSLATION AND USING A MULTICULTURAL DESIGN TO FACILITATE RECRUITMENT AND RETENTION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, NCT01617421.	2018	

6 1240  46 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
7 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
8  312  45 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	
                                                                                                                                                                                                                                                                                                                              
9  345  33 ASSESSING FEASIBILITY AND ACCEPTABILITY OF YOGA AND GROUP CBT FOR ADOLESCENTS WITH DEPRESSION: A PILOT RANDOMIZED CLINICAL TRIAL. PURPOSE: GIVEN INCREASING RATES OF DEPRESSION IN ADOLESCENTS, THERE IS A CLEAR NEED FOR INNOVATIVE TREATMENTS. IN THIS PILOT RANDOMIZED CLINICAL TRIAL, WE ASSESSED ACCEPTABILITY AND FEASIBILITY OF TWO GROUP-BASED INTERVENTIONS: YOGA AND COGNITIVE-BEHAVIORAL THERAPY (CBT). THE GOAL OF THIS WORK IS TO PREPARE FOR A FUTURE FULLY POWERED RANDOMIZED TRIAL TO TEST THE HYPOTHESIS THAT YOGA IS NOT INFERIOR TO AN ESTABLISHED ADOLESCENT DEPRESSION TREATMENT, NAMELY, GROUP CBT. METHODS: WE ENROLLED 42 ADOLESCENTS WITH ELEVATED DEPRESSION SYMPTOMS. PARTICIPANTS WERE RANDOMLY ASSIGNED TO A 12-WEEK GROUP-BASED INTERVENTION, YOGA OR CBT. WE HAD A PRIORI FEASIBILITY AND ACCEPTABILITY TARGETS, INCLUDING FOR RECRUITMENT RATE, RETENTION RATE, EXPECTANCY, CREDIBILITY, PROGRAM SATISFACTION, CLASS ATTENDANCE, ENGAGEMENT IN HOME PRACTICE, AND INSTRUCTOR/LEADER MANUAL ADHERENCE. WE ASSESSED ADVERSE EVENTS, AND WITHIN-SUBJECT CHANGES IN OUTCOMES (DEPRESSION, ANXIETY, IMPAIRMENT, SLEEP DISTURBANCE) AND POSSIBLE MEDIATORS (MINDFULNESS, SELF-COMPASSION). RESULTS: BOTH INTERVENTIONS MET MOST ACCEPTABILITY AND FEASIBILITY TARGETS. THE ONLY TARGET NOT MET RELATED TO LOW ENGAGEMENT IN HOME PRACTICE. PARTICIPANTS WITHIN EACH STUDY ARM SHOWED DECREASED DEPRESSION SYMPTOMS OVER TIME AND INCREASED SELF-COMPASSION. CONCLUSIONS: A YOGA INTERVENTION APPEARS TO BE ACCEPTABLE AND FEASIBLE TO ADOLESCENTS WITH DEPRESSION. HOWEVER, IT MAY BE CHALLENGING FOR THIS GROUP TO ENGAGE IN UNSTRUCTURED HOME PRACTICE.	2022	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
10  478  39 CLINICAL CASE REPORT: YOGA FOR FATIGUE IN FIVE YOUNG ADULT SURVIVORS OF CHILDHOOD CANCER. PURPOSE: CANCER-RELATED FATIGUE (CRF) IS A DISTRESSING CONSEQUENCE OF CANCER AND ITS TREATMENT. CRF IMPACTS MANY YOUNG ADULT (YA) SURVIVORS OF CHILDHOOD CANCER, COMPROMISING WORK, SOCIAL RELATIONSHIPS, AND DAILY ACTIVITIES. NO SATISFACTORY TREATMENT EXISTS. THIS PILOT STUDY AIMED TO ASSESS THE FEASIBILITY, SAFETY, AND PRELIMINARY EFFICACY OF AN 8-WEEK TWICE/WEEK IYENGAR YOGA (IY) INTERVENTION FOR TREATING PERSISTENT FATIGUE IN YA SURVIVORS OF CHILDHOOD CANCER. METHODS: USING A SINGLE-ARM MIXED-METHODS DESIGN, ADULT CHILDHOOD CANCER SURVIVORS AGED BETWEEN 18 AND 39 YEARS WERE RECRUITED FROM A SURVIVORSHIP CLINIC AT A SINGLE INSTITUTION. QUANTITATIVE: THE PRIMARY OUTCOME WAS FATIGUE AS MEASURED BY THE FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATIGUE. SECONDARY OUTCOMES INCLUDED VITALITY, SOCIAL FUNCTIONING, MULTIDIMENSIONAL FATIGUE, MOOD, AND SLEEP. WEEKLY SELF-REPORT MONITORING DATA WERE COLLECTED. QUALITATIVE: PARTICIPANTS ALSO COMPLETED A POST-INTERVENTION INTERVIEW, MAJOR THEMES EVALUATED. RESULTS: FIVE PARTICIPANTS ENROLLED INTO THE STUDY AND FOUR COMPLETED THE INTERVENTION. ATTENDANCE WAS 92% AND THERE WERE NO ADVERSE EVENTS. BASELINE MOBILITY WAS HIGHLY VARIED, WITH ONE YA HAVING HAD A HEMIPELVECTOMY. QUANTITATIVE DATA REVEALED SIGNIFICANTLY IMPROVED FATIGUE, SOCIAL FUNCTIONING, SOMATIZATION, AND GENERAL AND EMOTIONAL MANIFESTATIONS OF FATIGUE FOLLOWING YOGA. QUALITATIVE DATA CROSS VALIDATED, CLARIFIED, AND EXPANDED UPON THE QUANTITATIVE FINDINGS. CONCLUSIONS: THE STUDY SUGGESTS THAT A BRIEF IY INTERVENTION IS SAFE FOR YA SURVIVORS OF CHILDHOOD CANCER, EVEN FOR THOSE WITH PHYSICAL DISABILITIES. PRELIMINARY EFFICACY WAS DEMONSTRATED FOR THE PRIMARY OUTCOME OF FATIGUE. QUALITATIVE DATA ELUCIDATED ADDITIONAL IMPROVEMENTS, SUCH AS WORK-RELATED SOCIAL FUNCTIONING, AND A SENSE OF CALM AND RELAXATION.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
11   70  42 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
12 2628  34 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
13 2830  37 YOGA VS STRETCHING IN VETERANS WITH CHRONIC LOWER BACK PAIN AND THE ROLE OF MINDFULNESS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE FEASIBILITY OF RECRUITING, RANDOMIZING, ENROLLING, AND COLLECTING OUTCOME DATA ON VETERAN PATIENTS WITH CHRONIC LOW BACK PAIN (CLBP) WHO UNDERGO AN 8-WEEK, ACTIVE EXERCISE CLASS WITH MINDFULNESS (YOGA CLASS) AND WITHOUT (STRETCHING CLASS). METHODS: UNITED STATES VETERANS WITH CLBP BASED ON INCLUSION/EXCLUSION CRITERIA WERE RANDOMIZED TO 1 OF 2 GROUPS. THE STUDY DESIGN WAS A PILOT RANDOMIZED CONTROLLED TRIAL. TWENTY CLBP PATIENTS ATTENDED A YOGA CLASS OR STRETCHING CLASS ONCE PER WEEK FOR 8 WEEKS AT THE VETERANS AFFAIRS ROCHESTER OUTPATIENT CENTER, ROCHESTER, NEW YORK. THE FOLLOWING MEASUREMENTS WERE OBTAINED: RECRUITMENT OR ENROLLMENT DATA, COMPLIANCE DATA TO INCLUDE CLASS ATTENDANCE AND HOME EXERCISE, AND COMPLIANCE DATA REGARDING ABILITY TO COLLECT OUTCOME MEASURES AT BASELINE AND AT COMPLETION. OUTCOME MEASURES INCLUDED PAIN (PEG), QUALITY OF LIFE (PROMIS GLOBAL HEALTH SURVEY), SELF-EFFICACY (2-ITEM QUESTIONNAIRE), FEAR AVOIDANCE BELIEF, CATASTROPHIZING, AND SOCIAL ENGAGEMENT IN ADDITION TO QUALITATIVE CLINICIAN OPEN-ENDED QUESTIONS POSTINTERVENTION. RESULTS: FORTY-FIVE VETERANS WERE QUERIED REGARDING INTEREST IN PARTICIPATION. OF THESE, 34 (76%) MET THE STUDY'S CRITERIA. TWENTY (44%) AGREED TO PARTICIPATE AND WERE CONSENTED, RANDOMIZED, AND ENROLLED IN THE STUDY. INITIAL AND FINAL OUTCOME MEASURES WERE OBTAINED FOR EACH PARTICIPANT (100%). FORTY PERCENT ATTENDED MORE THAN 80% OF THE SESSIONS FOR BOTH YOGA AND STRETCHING GROUPS. CONCLUSION: THIS PILOT STUDY DEMONSTRATED FEASIBILITY OF RECRUITING, ENROLLING, AND COLLECTING OUTCOME DATA ON CLBP VETERAN PATIENTS PARTICIPATING IN YOGA AND STRETCHING CLASS. THE DATA FROM THIS PILOT WILL INFORM THE DEVELOPMENT OF A RANDOMIZED, COMPARATIVE EFFECTIVENESS STUDY OF YOGA WITH AND WITHOUT MINDFULNESS IN THE MANAGEMENT OF CLBP.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
14 1331  30 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
15 1192  34 EXAMINING A THERAPEUTIC YOGA PROGRAM FOR PROSTATE CANCER SURVIVORS. BACKGROUND: IN THE EARLIER STAGES OF PROSTATE CANCER, EFFECTIVE TREATMENTS HAVE CREATED A NEED FOR RESEARCH TO FOCUS ON PRACTICES THAT MAY IMPROVE QUALITY OF LIFE THROUGHOUT SURVIVORSHIP. PHYSICAL ACTIVITY IS A SIGNIFICANT SUPPORTIVE CARE MANAGEMENT STRATEGY FOR PROSTATE CANCER SURVIVORS, THOUGH THE OPTIMAL MODALITY IS NOT YET UNDERSTOOD. HYPOTHESES: THE AUTHORS HYPOTHESIZED THAT YOGA WOULD BE A FEASIBLE PHYSICAL ACTIVITY OPTION FOR PROSTATE CANCER SURVIVORS AND THEIR SUPPORT PERSONS AND THAT THE INCORPORATION OF SOCIAL SUPPORT WOULD INCREASE PHYSICAL ACTIVITY ADHERENCE. METHODS: THIS 14-WEEK FEASIBILITY STUDY INVOLVED A 7-WEEK CLASS-BASED YOGA PROGRAM (ADHERENCE PHASE), FOLLOWED BY 7 WEEKS OF SELF-SELECTED PHYSICAL ACTIVITY (MAINTENANCE PHASE). DEMOGRAPHIC INFORMATION, PHYSICAL ACTIVITY BEHAVIOR, QUALITY OF LIFE, FATIGUE, STRESS, MOOD, AND FITNESS VARIABLES WERE ASSESSED AT 3 TIME POINTS. PROSTATE CANCER SURVIVORS' PERCEIVED SOCIAL SUPPORT WAS RATED DURING YOGA AND AFTER YOGA. RESULTS: CLASS ATTENDANCE WAS 6.1 AND 5.8 FOR PROSTATE CANCER SURVIVORS (N = 15) AND THEIR SUPPORT PERSONS (N = 10), RESPECTIVELY, FOR THE 7 CLASSES. LEVELS OF PERCEIVED SOCIAL SUPPORT WERE HIGHER FOR THOSE WHO BROUGHT A SUPPORT PERSON. SIGNIFICANT IMPROVEMENTS WITH REGARD TO STRESS, FATIGUE, AND MOOD BEFORE AND AFTER YOGA CLASS (ALL PS < .05) WERE REPORTED BY ALL PARTICIPANTS. NO CLINICALLY SIGNIFICANT CHANGES WERE NOTED ON PROSTATE CANCER SURVIVOR'S QUALITY OF LIFE OR FATIGUE OVER THE COURSE OF THE 14-WEEK STUDY. CONCLUSIONS: YOGA IS A FEASIBLE PHYSICAL ACTIVITY OPTION FOR PROSTATE CANCER SURVIVORS. THE PROGRAM HAD A PROMISING UPTAKE RATE, HIGH PROGRAM ADHERENCE RATE, AND THERE WERE ACUTE PROGRAM BENEFITS WITH REGARD TO STRESS, FATIGUE, AND MOOD FOR ALL PARTICIPANTS. FUTURE EXAMINATION IS WARRANTED WITH REGARD TO CHRONIC BENEFITS AND GROUP COHESION INFLUENCES ON LEVELS OF PERCEIVED SOCIAL SUPPORT.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
16 2360  36 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  172  40 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
18 2558  39 YOGA FOR CHRONIC LOW BACK PAIN IN A PREDOMINANTLY MINORITY POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: SEVERAL STUDIES SUGGEST YOGA MAY BE EFFECTIVE FOR CHRONIC LOW BACK PAIN; HOWEVER, TRIALS TARGETING MINORITIES HAVE NOT BEEN CONDUCTED. PRIMARY STUDY OBJECTIVES: ASSESS THE FEASIBILITY OF STUDYING YOGA IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN. COLLECT PRELIMINARY DATA TO PLAN A LARGER POWERED STUDY. STUDY DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: TWO COMMUNITY HEALTH CENTERS IN A RACIALLY DIVERSE NEIGHBORHOOD OF BOSTON, MASSACHUSETTS. PARTICIPANTS: THIRTY ENGLISH-SPEAKING ADULTS (MEAN AGE 44 YEARS, 83% FEMALE, 83% RACIAL/ETHNIC MINORITIES; 48% WITH INCOMES < OR = $30,000) WITH MODERATE-TO-SEVERE CHRONIC LOW BACK PAIN. INTERVENTIONS: STANDARDIZED SERIES OF WEEKLY HATHA YOGA CLASSES FOR 12 WEEKS COMPARED TO A WAITLIST USUAL CARE CONTROL. OUTCOME MEASURES: FEASIBILITY MEASURED BY TIME TO COMPLETE ENROLLMENT, PROPORTION OF RACIAL/ETHNIC MINORITIES ENROLLED, RETENTION RATES, AND ADVERSE EVENTS. PRIMARY EFFICACY OUTCOMES WERE CHANGES FROM BASELINE TO 12 WEEKS IN PAIN SCORE (0=NO PAIN TO 10=WORST POSSIBLE PAIN) AND BACK-RELATED FUNCTION USING THE MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE (0-23 POINT SCALE, HIGHER SCORES REFLECT POORER FUNCTION). SECONDARY EFFICACY OUTCOMES WERE ANALGESIC USE, GLOBAL IMPROVEMENT, AND QUALITY OF LIFE (SF-36). RESULTS: RECRUITMENT TOOK 2 MONTHS. RETENTION RATES WERE 97% AT 12 WEEKS AND 77% AT 26 WEEKS. MEAN PAIN SCORES FOR YOGA DECREASED FROM BASELINE TO 12 WEEKS (6.7 TO 4.4) COMPARED TO USUAL CARE, WHICH DECREASED FROM 7.5 TO 7.1 (P=.02). MEAN ROLAND SCORES FOR YOGA DECREASED FROM 14.5 TO 8.2 COMPARED TO USUAL CARE, WHICH DECREASED FROM 16.1 TO 12.5 (P=.28). AT 12 WEEKS, YOGA COMPARED TO USUAL CARE PARTICIPANTS REPORTED LESS ANALGESIC USE (13% VS 73%, P=.003), LESS OPIATE USE (0% VS 33%, P=.04), AND GREATER OVERALL IMPROVEMENT (73% VS 27%, P=.03). THERE WERE NO DIFFERENCES IN SF-36 SCORES AND NO SERIOUS ADVERSE EVENTS. CONCLUSION: A YOGA STUDY INTERVENTION IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN WAS MODERATELY FEASIBLE AND MAY BE MORE EFFECTIVE THAN USUAL CARE FOR REDUCING PAIN AND PAIN MEDICATION USE.	2009	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
19  420  38 BRIDGING BODY AND MIND: CASE SERIES OF A 10-WEEK TRAUMA-INFORMED YOGA PROTOCOL FOR VETERANS. THIS CASE SERIES EXPLORED THE FEASIBILITY AND PRELIMINARY EFFICACY OF THERAPEUTIC YOGA AS A COMPLEMENTARY FORM OF TREATMENT FOR COMBAT-RELATED TRAUMA. THE SERIES RECRUITED FOR AND IMPLEMENTED A 10-WEEK TRAUMA-INFORMED YOGA PROTOCOL FOR VETERANS IN AN INTERPROFESSIONAL COMMUNITY HEALTH TREATMENT SETTING. PARTICIPANTS WERE ENROLLED IN A SERIES OF 90-MINUTE THERAPEUTIC YOGA CLASSES ADAPTED TO BE TRAUMA-INFORMED. FEASIBILITY WAS MEASURED BY RECRUITMENT, RETENTION, AND LEVEL OF PARTICIPATION IN THE STUDY. PRELIMINARY EFFICACY WAS EXPLORED VIA THE POSTTRAUMATIC STRESS DISORDER CHECKLIST, SCALE OF BODY CONNECTION, PROMIS-29, PROMIS ALCOHOL USE, PROMIS SUBSTANCE USE, DIFFICULTIES IN EMOTIONAL REGULATION SCALE, AND SELF-COMPASSION SCALE-SHORT FORM. ALL MEASURES WERE ADMINISTERED AT BASELINE, WEEK 5, WEEK 10, AND AT A 5-WEEK FOLLOW-UP. A QUALITATIVE FEASIBILITY QUESTIONNAIRE WAS ADMINISTERED WEEKLY AND AT THE 5-WEEK FOLLOW-UP TO ASSESS BARRIERS AND MOTIVATORS FOR HOME PRACTICE AND TO COLLECT FEEDBACK ABOUT SESSION CONTENT. RECRUITMENT CHALLENGES RESULTED IN ONLY SEVEN INTERESTED INDIVIDUALS. FOUR PARTICIPANTS (THREE MALES, ONE FEMALE) WERE SUCCESSFULLY ENROLLED IN THE STUDY AFTER SEVEN PHONE SCREENINGS AND FIVE IN-PERSON INTERVIEWS. THE FOUR ENROLLED CLIENTS HAD A 100% FOLLOW-UP RETENTION RATE, REPORTED NO ADVERSE EVENTS, AND ON AVERAGE PARTICIPATED IN 85% OF CLASSES. CLINICALLY SIGNIFICANT ENHANCEMENTS WERE OBSERVED ON TRAUMA- AND BODY CONNECTION-RELATED SCALES FOR THREE PARTICIPANTS FROM BASELINE TO FOLLOW-UP. QUALITATIVE DATA REVEALED THAT MOTIVATORS TO PRACTICE INCLUDE IN-SESSION PHILOSOPHICAL DISCUSSIONS BASED ON PSYCHOLOGICAL THEMES; BREATHWORK; MINDFULNESS; AND PHYSICAL, SOCIAL, WORK/ACADEMIC, AND MENTAL HEALTH IMPACT. BARRIERS INCLUDED MOTIVATION, TIME, AND LOCATION. IMPORTANT THEMES EMERGED RELATED TO CULTURAL CONSIDERATIONS FOR VETERANS. ALTHOUGH THIS 10-WEEK TRAUMA-INFORMED PROTOCOL FACED CHALLENGES TO RECRUITMENT, RETENTION AND PARTICIPATION WERE HIGH. EFFICACY MEASURES YIELDED PROMISING RESULTS FOR REDUCING TRAUMA-RELATED SYMPTOMS.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
20 1243  49 FEASIBILITY OF A YOGA, AEROBIC AND STRETCHING-TONING EXERCISE PROGRAM FOR ADULT CANCER SURVIVORS: THE STAYFIT TRIAL. BACKGROUND: THE USE OF YOGA AS A MIND-BODY PRACTICE HAS BECOME INCREASINGLY POPULAR AMONG CLINICAL POPULATIONS AND OLDER ADULTS WHO USE THIS PRACTICE TO MANAGE AGE AND CHRONIC DISEASE-RELATED SYMPTOMS. ALTHOUGH YOGA CONTINUES TO GAIN POPULARITY AMONG PRACTITIONERS AND RESEARCHERS, PILOT STUDIES THAT EXAMINE ITS FEASIBILITY AND ACCEPTABILITY, ESPECIALLY AMONG CANCER SURVIVORS, ARE LIMITED. FEASIBILITY STUDIES PLAY A CRITICAL ROLE IN DETERMINING WHETHER THE TARGET POPULATION IS LIKELY TO ENGAGE WITH LARGER SCALE EFFICACY AND EFFECTIVENESS TRIALS. IN THIS PAPER WE PRESENT FEASIBILITY AND ACCEPTABILITY DATA FROM A 12-WEEK RANDOMIZED CONTROLLED TRIAL (RCT) CONDUCTED WITH ADULT CANCER SURVIVORS. METHODS: PARTICIPANTS N = 78 (MEAN AGE: 55 YEARS) WERE RANDOMIZED TO ONE OF THREE GROUPS: A HATHA YOGA, AEROBIC EXERCISE, OR STRETCHING-TONING CONTROL GROUP WITH GROUP EXERCISE CLASSES HELD FOR 150 MIN/WEEK FOR 12 WEEKS. HEREIN WE REPORT FEASIBILITY AND ACCEPTABILITY, INCLUDING ENROLLMENT RATES, ATTENDANCE, ATTRITION AND ADVERSE EVENTS, AND PARTICIPANT FEEDBACK AND SATISFACTION DATA. RESULTS: OF THE 233 ADULTS SCREENED, 109 WERE ELIGIBLE AND 78 RANDOMIZED TO ONE OF THE THREE INTERVENTION ARMS. SESSION ATTENDANCE WAS HIGH FOR ALL GROUPS (75.5-89.5%) AND 17 PARTICIPANTS DROPPED OUT DURING THE 12-WEEK INTERVENTION. PROGRAM SATISFACTION WAS HIGH (4.8 OR HIGHER OUT OF 5) AND NO ADVERSE EVENTS WERE REPORTED. ONE COHORT (N = 15) OF THE INTERVENTION TRANSITIONED TO REMOTE INTERVENTION DELIVERY DUE TO THE COVID-19 PANDEMIC. FEASIBILITY DATA FROM THESE PARTICIPANTS SUGGESTED THAT SYNCHRONIZED GROUP EXERCISE CLASSES VIA ZOOM WITH A LIVE INSTRUCTOR WERE ACCEPTABLE AND ENJOYABLE. PARTICIPANT FEEDBACK REGARDING MOST AND LEAST HELPFUL ASPECTS OF THE PROGRAM AS WELL AS SUGGESTIONS FOR FUTURE YOGA INTERVENTIONS ARE SUMMARIZED. CONCLUSIONS: OVERALL, THE YOGA INTERVENTION WAS HIGHLY FEASIBLE AND ACCEPTABLE. THE FEASIBILITY PARAMETERS FROM THIS TRIAL CAN AID RESEARCHERS IN ESTIMATING RECRUITMENT RATES FOR DESIRED SAMPLE SIZES TO SUCCESSFULLY RANDOMIZE AND RETAIN CANCER SURVIVORS IN SHORT- AND LONG-TERM YOGA-BASED EFFICACY AND EFFECTIVENESS TRIALS. THE FINDINGS ALSO PROVIDE EVIDENCE TO CLINICIANS WHO CAN RECOMMEND UP TO 150 MIN OF A COMBINATION OF EXERCISES-AEROBIC, YOGA, OR STRETCHING-TONING TO THEIR CANCER PATIENTS IN ORDER TO IMPROVE HEALTH AND WELLBEING DURING CANCER SURVIVORSHIP.	2021