1 1748 152 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 2 199 57 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 3 619 35 DEVELOPMENT OF THE CLARIFY (CHECKLIST STANDARDISING THE REPORTING OF INTERVENTIONS FOR YOGA) GUIDELINES: A DELPHI STUDY. BACKGROUND: THE USE OF YOGA AS A THERAPEUTIC MODALITY IS INCREASING; HOWEVER, A LACK OF TRANSPARENT INTERVENTION REPORTING IS RESTRICTING THE DISSEMINATION AND IMPLEMENTATION OF YOGA RESEARCH INTO CLINICAL AND COMMUNITY PRACTICE. THE AIM OF THIS STUDY WAS TO DEVELOP A YOGA-SPECIFIC REPORTING GUIDELINE AS AN EXTENSION TO EXISTING REPORTING GUIDELINES FOR RANDOMISED CONTROLLED TRIALS, OBSERVATIONAL STUDIES AND CASE REPORTS. METHODS: RECOGNISED INTERNATIONAL STAKEHOLDERS IN THE DESIGN AND CONDUCT OF YOGA RESEARCH WERE INVITED TO CONTRIBUTE TO THE ELECTRONIC DELPHI SURVEY. A FOUR-ROUND DELPHI WAS CONDUCTED, WHEREBY PANELLISTS RATED SELECTED ITEMS FOR THEIR IMPORTANCE IN THE INCLUSION OF YOGA REPORTING GUIDELINES, ACCORDING TO A 5-STEP LIKERT SCALE. A PRIORI CONSENSUS FOR ITEM INCLUSION WAS AGREEMENT OF ITEMS AS 'VERY IMPORTANT' OR 'EXTREMELY IMPORTANT' BY >/=80% OF PANELLISTS. NON-CONSENSUS ITEMS WERE FORWARDED TO SUBSEQUENT ROUNDS FOR RE-RATING. RESULTS: 53 EXPERTS IN YOGA RESEARCH FROM 11 COUNTRIES, PRIMARILY IDENTIFYING AS RESEARCHERS (50%), ALLIED HEALTH PROFESSIONALS (18.8%) AND YOGA PROFESSIONALS (12.5%), CONSENTED TO PARTICIPATE IN THE DELPHI. OF THESE, 48 COMPLETED ROUND 1 (91%), 43 COMPLETED ROUND 2 (81%), 39 COMPLETED ROUND 3 (74%) AND 32 COMPLETED ROUND 4 (60%). PANELLISTS REACHED CONSENSUS FOR INCLUSION ON 21 ITEMS, GROUPED UNDER 10 DOMAINS REFLECTIVE OF MORE GENERIC INTERVENTION-BASED GUIDELINES. CONCLUSIONS: THE CONSENSUS-BASED 21-ITEM CLARIFY (CHECKLIST STANDARDISING THE REPORTING OF INTERVENTIONS FOR YOGA) CHECKLIST PROVIDES A MINIMUM REPORTING TEMPLATE FOR RESEARCHERS ACROSS A RANGE OF METHODOLOGY DESIGNS. USE OF THESE YOGA-SPECIFIC GUIDELINES, IN CONJUNCTION WITH THE CLARIFY EXPLANATION AND ELABORATION GUIDELINES, WILL STANDARDISE THE MINIMUM LEVEL OF DETAIL REQUIRED FOR TRANSPARENT YOGA INTERVENTION, FACILITATING THE REPLICATION, DISSEMINATION AND IMPLEMENTATION OF YOGA RESEARCH. ONGOING RESEARCH WILL ASSESS THE UPTAKE AND IMPACT OF CLARIFY, TO ENSURE THESE GUIDELINES RETAIN THEIR RELEVANCE TO THE INTERNATIONALLY GROWING FIELD OF YOGA RESEARCH. 2022 4 1165 49 EVALUATING THE FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES IN PEOPLE LIVING WITH HIV: PROTOCOL FOR A RANDOMIZED PILOT TRIAL. BACKGROUND: DESPITE LOWER MORTALITY RATES DUE TO COMBINATION ANTIRETROVIRAL THERAPY, PEOPLE LIVING WITH HIV (PLWH) ARE GRAPPLING WITH INCREASINGLY COMPLEX HEALTH ISSUES, INCLUDING COGNITIVE IMPAIRMENTS IN AREAS SUCH AS MEMORY, ATTENTION, PROCESSING SPEED, AND MOTOR FUNCTION. YOGA HAS BEEN SHOWN TO BE AN EFFECTIVE FORM OF EXERCISE AND MINDFULNESS-BASED STRESS REDUCTION FOR MANY CLINICAL POPULATIONS. HOWEVER, NO RANDOMIZED TRIALS HAVE EVALUATED THE IMPACT OF YOGA ON COGNITIVE AND PHYSICAL FUNCTION AMONG PLWH. OBJECTIVE: THE AIM OF THIS PILOT RANDOMIZED TRIAL WAS TO DETERMINE THE FEASIBILITY OF A YOGA INTERVENTION TO LAY THE GROUNDWORK FOR A FULL-SCALE, MULTISITE, COMMUNITY-BASED TRIAL FOR PLWH. SPECIFIC OBJECTIVES ARE TO (1) ASSESS THE FEASIBILITY OF STUDY PROTOCOL AND PROCEDURES, (2) COMPARE COGNITION IN THE YOGA GROUP WITH THE USUAL CARE CONTROL GROUP AFTER 12 WEEKS OF THE INTERVENTION IN PLWH, AND (3) COMPARE THE EFFECTS OF THE 12-WEEK YOGA INTERVENTION VERSUS CONTROL ON BALANCE, WALKING SPEED, PHYSICAL ACTIVITY, MENTAL HEALTH, MEDICATION ADHERENCE, AND QUALITY OF LIFE AMONG PLWH. METHODS: WE PROPOSE A PILOT RANDOMIZED TRIAL WITH 2 PARALLEL GROUPS (YOGA VERSUS CONTROL). WE WILL RECRUIT 25 PLWH (>35 YEARS) FROM COMMUNITY AND HEALTH ORGANIZATIONS IN HALIFAX, CANADA. AFTER BASELINE ASSESSMENT WITH BLINDED ASSESSORS, PARTICIPANTS WILL BE RANDOMLY ASSIGNED TO THE YOGA OR CONTROL GROUP, USING A RANDOM COMPUTER GENERATOR. PARTICIPANTS IN THE YOGA GROUP WILL ENGAGE IN SUPERVISED 60-MIN GROUP-BASED YOGA SESSIONS 3 TIMES A WEEK FOR 12 WEEKS AT A YOGA STUDIO. PARTICIPANTS IN THE CONTROL GROUP WILL MAINTAIN THEIR CURRENT PHYSICAL ACTIVITY LEVELS THROUGHOUT THE STUDY. RESULTS: AS PER THE CONSOLIDATED STANDARDS OF REPORTING TRIALS EXTENSION FOR PILOT STUDIES, MEANS OF ALL OUTCOMES, MEAN CHANGE, AND 95% CIS WILL BE CALCULATED FOR EACH GROUP SEPARATELY. TWO-TAILED INDEPENDENT T TESTS AND FISHER EXACT TESTS WILL BE USED TO COMPARE GROUPS AT BASELINE. WE WILL ANALYZE QUANTITATIVE POSTINTERVENTION QUESTIONNAIRE RESPONSES USING CHI-SQUARE TESTS, AND OPEN-ENDED RESPONSES WILL BE ANALYZED THEMATICALLY. INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSES WILL BE USED TO ANALYZE SECONDARY VARIABLES. CHANGES IN OUTCOME VARIABLES WILL BE EXAMINED BETWEEN GROUPS AND WITHIN GROUPS. EFFECT SIZES WILL BE REPORTED FOR EACH OUTCOME. A PRIORI ADHERENCE AND SATISFACTION CRITERIA WILL BE MET IF PARTICIPANTS ATTEND >70% OF THE YOGA SESSIONS AND IF >70% OF THE PARTICIPANTS ARE SATISFIED WITH THE INTERVENTION AS DETERMINED BY A POSTPARTICIPATION QUESTIONNAIRE. STUDY ENROLLMENT BEGAN IN JANUARY 2018, WITH RESULTS EXPECTED FOR OCTOBER 2019. CONCLUSIONS: THIS PILOT RANDOMIZED TRIAL WILL BE THE FIRST TO INVESTIGATE THE FEASIBILITY AND EFFECT OF A YOGA INTERVENTION ON COGNITIVE AND PHYSICAL OUTCOMES AMONG PLWH. THIS WORK WILL INFORM THE FEASIBILITY OF FURTHER INVESTIGATIONS IN TERMS OF CAPACITY BUILDING, PARTICIPANT RECRUITMENT AND RETENTION, AND ASSESSMENT AND INTERVENTION PROTOCOLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03071562; HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03071562 (ARCHIVED BY WEBCITE AT HTTP://WWW.WEBCITATION.ORG/785SFHWKW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13818. 2019 5 1158 40 ESTABLISHING KEY COMPONENTS OF YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS: A DELPHI SURVEY. BACKGROUND: EVIDENCE SUGGESTS YOGA IS A SAFE AND EFFECTIVE INTERVENTION FOR THE MANAGEMENT OF PHYSICAL AND PSYCHOSOCIAL SYMPTOMS ASSOCIATED WITH MUSCULOSKELETAL CONDITIONS. HOWEVER, HETEROGENEITY IN THE COMPONENTS AND REPORTING OF CLINICAL YOGA TRIALS IMPEDES BOTH THE GENERALIZATION OF STUDY RESULTS AND THE REPLICATION OF STUDY PROTOCOLS. THE AIM OF THIS DELPHI SURVEY WAS TO ADDRESS THESE ISSUES OF HETEROGENEITY, BY DEVELOPING A LIST OF RECOMMENDATIONS OF KEY COMPONENTS FOR THE DESIGN AND REPORTING OF YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: RECOGNISED EXPERTS INVOLVED IN THE DESIGN, CONDUCT, AND TEACHING OF YOGA FOR MUSCULOSKELETAL CONDITIONS WERE IDENTIFIED FROM A SYSTEMATIC REVIEW, AND INVITED TO CONTRIBUTE TO THE DELPHI SURVEY. FORTY-ONE OF THE 58 EXPERTS CONTACTED, REPRESENTING SIX COUNTRIES, AGREED TO PARTICIPATE. A THREE-ROUND DELPHI WAS CONDUCTED VIA ELECTRONIC SURVEYS. ROUND 1 PRESENTED AN OPEN-ENDED QUESTION, ALLOWING PANELLISTS TO INDIVIDUALLY IDENTIFY COMPONENTS THEY CONSIDERED KEY TO THE DESIGN AND REPORTING OF YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. THEMATIC ANALYSIS OF ROUND 1 IDENTIFIED ITEMS FOR QUANTITATIVE RATING IN ROUND 2; ITEMS NOT REACHING CONSENSUS WERE FORWARDED TO ROUND 3 FOR RE-RATING. RESULTS: THIRTY-SIX PANELLISTS (36/41; 88%) COMPLETED THE THREE ROUNDS OF THE DELPHI SURVEY. PANELLISTS PROVIDED 348 COMMENTS TO THE ROUND 1 QUESTION. THESE COMMENTS WERE REDUCED TO 49 ITEMS, GROUPED UNDER FIVE THEMES, FOR RATING IN SUBSEQUENT ROUNDS. A PRIORI GROUP CONSENSUS OF >/=80% WAS REACHED ON 28 ITEMS RELATED TO FIVE THEMES CONCERNING DEFINING THE YOGA INTERVENTION, TYPES OF YOGA PRACTICES TO INCLUDE IN AN INTERVENTION, DELIVERY OF THE YOGA PROTOCOL, DOMAINS OF OUTCOME MEASURES, AND REPORTING OF YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. ADDITIONALLY, A PRIORI CONSENSUS OF >/=50% WAS REACHED ON FIVE ITEMS RELATING TO MINIMUM VALUES FOR INTERVENTION PARAMETERS. CONCLUSIONS: EXPERT CONSENSUS HAS PROVIDED A NON-PRESCRIPTIVE REFERENCE LIST FOR THE DESIGN AND REPORTING OF YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. IT IS ANTICIPATED FUTURE RESEARCH INCORPORATING THE DELPHI GUIDELINES WILL FACILITATE HIGH QUALITY INTERNATIONAL RESEARCH IN THIS FIELD, INCREASE HOMOGENEITY OF INTERVENTION COMPONENTS AND PARAMETERS, AND ENHANCE THE COMPARISON AND REPRODUCIBILITY OF RESEARCH INTO THE USE OF YOGA FOR THE MANAGEMENT OF MUSCULOSKELETAL CONDITIONS. 2014 6 648 84 DYADIC YOGA PROGRAM FOR PATIENTS UNDERGOING THORACIC RADIOTHERAPY AND THEIR FAMILY CAREGIVERS: RESULTS OF A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THORACIC RADIOTHERAPY (TRT) MAY RESULT IN TOXICITIES THAT ARE ASSOCIATED WITH PERFORMANCE DECLINES AND POOR QUALITY OF LIFE (QOL) FOR PATIENTS AND THEIR FAMILY CAREGIVERS. THE PURPOSE OF THIS RANDOMIZED CONTROLLED TRIAL WAS TO ESTABLISH FEASIBILITY AND PRELIMINARY EFFICACY OF A DYADIC YOGA (DY) INTERVENTION AS A SUPPORTIVE CARE STRATEGY. METHODS: PATIENTS WITH STAGE I TO III NON-SMALL CELL LUNG OR ESOPHAGEAL CANCER UNDERGOING TRT AND THEIR CAREGIVERS (N = 26 DYADS) WERE RANDOMIZED TO A 15-SESSION DY OR A WAITLIST CONTROL (WLC) GROUP. PRIOR TO TRT AND RANDOMIZATION, BOTH GROUPS COMPLETED MEASURES OF QOL (SF-36) AND DEPRESSIVE SYMPTOMS (CES-D). PATIENTS ALSO COMPLETED THE 6-MINUTE WALK TEST (6MWT). DYADS WERE REASSESSED ON THE LAST DAY OF TRT AND 3 MONTHS LATER. RESULTS: A PRIORI FEASIBILITY CRITERIA WERE MET REGARDING CONSENT (68%), ADHERENCE (80%), AND RETENTION (81%) RATES. CONTROLLING FOR RELEVANT COVARIATES, MULTILEVEL MODELING ANALYSES REVEALED SIGNIFICANT CLINICAL IMPROVEMENTS FOR PATIENTS IN THE DY GROUP COMPARED WITH THE WLC GROUP FOR THE 6MWT (MEANS: DY = 473 M VS WLC = 397 M, D = 1.19) AND SF-36 PHYSICAL FUNCTION (MEANS: DY = 38.77 VS WLC = 30.88; D = .66) AND SOCIAL FUNCTION (MEANS: DY = 45.24 VS WLC = 39.09; D = .44) ACROSS THE FOLLOW-UP PERIOD. CAREGIVERS IN THE DY GROUP REPORTED MARGINALLY CLINICALLY SIGNIFICANT IMPROVEMENTS IN SF-36 VITALITY (MEANS: DY = 53.05 VS WLC = 48.84; D = .39) AND ROLE PERFORMANCE (MEANS: DY = 52.78 VS WLC = 48.59; D = .51) RELATIVE TO THOSE IN THE WLC GROUP. CONCLUSIONS: THIS NOVEL SUPPORTIVE CARE PROGRAM APPEARS TO BE FEASIBLE AND BENEFICIAL FOR PATIENTS UNDERGOING TRT AND THEIR CAREGIVERS. A LARGER EFFICACY TRIAL WITH A MORE STRINGENT CONTROL GROUP IS WARRANTED. 2019 7 345 42 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 8 70 41 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 9 551 35 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 10 258 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 11 41 49 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 12 1224 40 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 13 2360 38 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 14 1228 37 FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES AMONG PEOPLE LIVING WITH HIV: A RANDOMIZED CONTROLLED PILOT TRIAL. THE PURPOSE OF THIS PILOT RANDOMIZED CONTROLLED TRIAL IS TO ASSESS THE FEASIBILITY AND IMPACT OF A TRIWEEKLY 12-WEEK YOGA INTERVENTION AMONG PEOPLE LIVING WITH HIV (PLWH). ADDITIONAL OBJECTIVES INCLUDED EVALUATING COGNITION, PHYSICAL FUNCTION, MEDICATION ADHERENCE, HEALTH-RELATED QUALITY OF LIFE (HRQOL), AND MENTAL HEALTH AMONG YOGA PARTICIPANTS VERSUS CONTROLS USING BLINDED ASSESSORS. WE RECRUITED 22 MEDICALLY STABLE PLWH AGED >/=35 YEARS. A PRIORI FEASIBILITY CRITERIA WERE >/=70% YOGA SESSION ATTENDANCE AND >/=70% OF PARTICIPANTS SATISFIED WITH THE INTERVENTION USING A POSTPARTICIPATION QUESTIONNAIRE. TWO PARTICIPANTS WITHDREW FROM THE YOGA GROUP. MEAN YOGA CLASS ATTENDANCE WAS 82%, WITH 100% SATISFACTION. INTENTION-TO-TREAT ANALYSES (YOGA N = 11, CONTROL N = 11) SHOWED NO WITHIN- OR BETWEEN-GROUP DIFFERENCES IN COGNITIVE AND PHYSICAL FUNCTION. THE YOGA GROUP IMPROVED OVER TIME IN HRQOL COGNITION (P = .047) WITH TRENDS TOWARD IMPROVEMENTS IN HRQOL HEALTH TRANSITION (P =.063) AND DEPRESSION (P = .055). THIS PILOT STUDY PROVIDES PRELIMINARY EVIDENCE OF FEASIBILITY AND BENEFITS OF YOGA FOR PLWH. 2020 15 119 42 A PILOT STUDY OF THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. OBJECTIVES: TO DETERMINE THE ACCEPTABILITY, FEASIBILITY AND SAFETY OF YOGA FOR CHRONIC PAIN IN SICKLE CELL DISEASE. DESIGN AND SETTING: IN PART A OF THIS TWO-PART STUDY, ADOLESCENTS WITH SCD AND CHRONIC PAIN (GROUP 1) AND THEIR PARENT (GROUP 2) COMPLETED A SURVEY DESIGNED TO CAPTURE PAIN CHARACTERISTICS, ATTITUDES AND PRACTICES RELATED TO YOGA, AND POTENTIAL ACCEPTABILITY OF A YOGA PROGRAM. IN PART B, THE STUDY ASSESSED THE FEASIBILITY AND SAFETY OF AN INSTRUCTOR-LED GROUP YOGA PROGRAM. THE STUDY WAS REGISTERED ON CLINICALTRIALS.GOV (NCT03694548). INTERVENTION: EIGHT INSTRUCTOR-LED GROUP YOGA SESSIONS. MAIN OUTCOME MEASURES: FEASIBILITY AND SAFETY OUTCOMES WERE CHOSEN A PRIORI, AS FOLLOWS: 1) PROPORTION OF ADOLESCENT PATIENTS WITH SCD AND CHRONIC PAIN APPROACHED THAT CONSENT TO PARTICIPATE IN PART A, 2) PROPORTION OF ADOLESCENT PARTICIPANTS ENROLLED IN PART A THAT CONSENT TO PARTICIPATE IN PART B, 3) PROPORTION OF PARTICIPANTS ENROLLED IN PART B THAT ATTEND AT LEAST 6 OF 8 YOGA SESSIONS, 4) PROPORTION OF PARTICIPANTS ENROLLED IN PART B WITH AN ED VISIT OR A HOSPITALIZATION FOR PAIN WITHIN 24 H OF COMPLETION OF EACH YOGA SESSION, 5) PROPORTION OF PARTICIPANTS IN PART B WHO COMPLETE ALL STUDY ASSESSMENTS BEFORE, AND AT THE END OF THE YOGA PROGRAM, 6) ADHERENCE TO SUBMISSION OF PAIN DIARY. RESULTS: THE MEDIAN AGE OF 15 PATIENT PARTICIPANTS IN PART A WAS 16 (IQR 14-17), AND 14 PARENTS WAS 43.5 (IQR 42-51). MOST PARTICIPANTS WERE FEMALE. MOST PARTICIPANT RESPONSES INDICATED A POSITIVE OPINION OF YOGA. NINE ADOLESCENTS (60 %) FROM PART A PARTICIPATED IN PART B OF THE STUDY. THE MEDIAN AGE OF 9 PARTICIPANTS IN PART B WAS 17 (IQR 15-18), AND 5 OF THE 9 PARTICIPANTS WERE FEMALE (53.3 %). ONLY ONE PARTICIPANT WAS ABLE TO ATTEND 3 OF THE 8 YOGA SESSIONS OFFERED, AND DID NOT EXPERIENCE ANY ED VISITS OR HOSPITALIZATIONS FOLLOWING THE YOGA SESSIONS. NONE OF THE OTHER FEASIBILITY ENDPOINTS WERE MET IN THIS STUDY. CONCLUSIONS: PATIENTS WITH SCD AND CHRONIC PAIN OVERALL HAVE A POSITIVE OPINION OF YOGA, BUT THERE ARE CHALLENGES WITH RECRUITMENT AND RETENTION OF PARTICIPANTS IN A CLINICAL TRIAL OF YOGA, AND BARRIERS TO FEASIBILITY OF AN IN-PERSON GROUP YOGA INTERVENTION. 2021 16 2831 30 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927. 2014 17 2389 49 YOGA AND AEROBIC DANCE FOR PAIN MANAGEMENT IN JUVENILE IDIOPATHIC ARTHRITIS: PROTOCOL FOR A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: JUVENILE IDIOPATHIC ARTHRITIS (JIA) IS ONE OF THE MOST COMMON TYPES OF ARTHRITIS AMONG CHILDREN. ACCORDING TO JIA GUIDELINES FOR PHYSICAL ACTIVITY (PA), STRUCTURED PA INTERVENTIONS LED TO IMPROVED HEALTH OUTCOMES. HOWEVER, MANY PA PROGRAMS, SUCH AS YOGA AND AEROBIC DANCE, HAVE NOT BEEN STUDIED IN THIS POPULATION DESPITE BEING POPULAR AMONG YOUTH. WEB-BASED PA PROGRAMS COULD PROVIDE PATIENTS WITH ACCESSIBLE AND AFFORDABLE INTERVENTIONS. OBJECTIVE: THE PRIMARY AIMS OF THE PROPOSED PILOT RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO EXAMINE (1) THE FEASIBILITY OF CONDUCTING A FULL-SCALE RCT TO EVALUATE THE EFFECTIVENESS OF TWO POPULAR TYPES OF PA: A YOGA TRAINING PROGRAM AND AN AEROBIC DANCE TRAINING PROGRAM, IN FEMALE ADOLESCENTS (AGED 13-18 YEARS) WITH JIA COMPARED WITH AN ELECTRONIC PAMPHLET CONTROL GROUP; AND (2) THE ACCEPTABILITY OF THESE INTERVENTIONS. METHODS: A THREE-ARM PROSPECTIVE RANDOMIZED OPEN-LABEL STUDY WITH A PARALLEL GROUP DESIGN WILL BE USED. A TOTAL OF 25 FEMALE ADOLESCENTS WITH JIA WHO HAVE PAIN WILL BE RANDOMIZED IN A RATIO OF 2:2:1 TO ONE OF THE 3 GROUPS: (1) ONLINE YOGA TRAINING PROGRAM (GROUP A: N=10); (2) ONLINE AEROBIC DANCE TRAINING PROGRAM (GROUP B: N=10); AND (3) ELECTRONIC PAMPHLET CONTROL GROUP (GROUP C: N=5). PARTICIPANTS IN GROUPS A AND B WILL COMPLETE 3 INDIVIDUAL 1-HOUR SESSIONS PER WEEK USING ONLINE EXERCISE VIDEOS, AS WELL AS A 1-HOUR VIRTUAL GROUP SESSION PER WEEK USING A VIDEOCONFERENCING PLATFORM FOR 12 WEEKS. PARTICIPANTS FROM ALL GROUPS WILL HAVE ACCESS TO AN ELECTRONIC EDUCATIONAL PAMPHLET ON PA FOR ARTHRITIS DEVELOPED BY THE ARTHRITIS SOCIETY. ALL PARTICIPANTS WILL ALSO TAKE PART IN WEEKLY ONLINE CONSULTATIONS WITH A RESEARCH COORDINATOR AND DISCUSSIONS ON FACEBOOK WITH PARTICIPANTS FROM THEIR OWN GROUP. FEASIBILITY (IE, RECRUITMENT RATE, SELF-REPORTED ADHERENCE TO THE INTERVENTIONS, DROPOUT RATES, AND PERCENTAGE OF MISSING DATA), ACCEPTABILITY, AND USABILITY OF FACEBOOK AND THE VIDEOCONFERENCING PLATFORM WILL BE ASSESSED AT THE END OF THE PROGRAM. PAIN INTENSITY, PARTICIPATION IN GENERAL PA, MORNING STIFFNESS, FUNCTIONAL STATUS, FATIGUE, SELF-EFFICACY, PATIENT GLOBAL ASSESSMENT, DISEASE ACTIVITY, AND ADVERSE EVENTS WILL BE ASSESSED USING SELF-ADMINISTERED ELECTRONIC SURVEYS AT BASELINE AND THEN WEEKLY UNTIL THE END OF THE 12-WEEK PROGRAM. RESULTS: THIS PILOT RCT HAS BEEN FUNDED BY THE ARTHRITIS HEALTH PROFESSIONS ASSOCIATION. THIS PROTOCOL WAS APPROVED BY THE CHILDREN'S HOSPITAL OF EASTERN ONTARIO RESEARCH ETHICS BOARD (#17/08X). AS OF MAY 11, 2020, RECRUITMENT AND DATA COLLECTION HAVE NOT STARTED. CONCLUSIONS: TO OUR KNOWLEDGE, THIS IS THE FIRST STUDY TO EVALUATE THE EFFECTIVENESS OF YOGA AND AEROBIC DANCE AS PAIN MANAGEMENT INTERVENTIONS FOR FEMALE ADOLESCENTS WITH JIA. THE USE OF ONLINE PROGRAMS TO DISSEMINATE THESE 2 PA INTERVENTIONS MAY FACILITATE ACCESS TO ALTERNATIVE METHODS OF PAIN MANAGEMENT. THIS STUDY CAN LEAD TO A FULL-SCALE RCT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12823. 2020 18 421 22 BRIDGING BODY AND MIND: CONSIDERATIONS FOR TRAUMA-INFORMED YOGA. INDIVIDUALS WHO SUFFER FROM TRAUMA-RELATED SYMPTOMS ARE A UNIQUE POPULATION THAT COULD BENEFIT FROM THE MIND-BODY PRACTICE OF YOGA-OR HAVE THEIR SYMPTOMS REACTIVATED BY IT, DEPENDING ON THE TYPE OF YOGA. TRAUMA-INFORMED YOGA (TIY), THAT IS, YOGA ADAPTED TO THE UNIQUE NEEDS OF INDIVIDUALS WORKING TO OVERCOME TRAUMA, MAY AMELIORATE SYMPTOMS BY CREATING A SAFE, TAILORED PRACTICE FOR STUDENTS TO LEARN HOW TO RESPOND, RATHER THAN REACT, TO SYMPTOMS AND CIRCUMSTANCES. YOGA NOT THUS ADAPTED, ON THE OTHER HAND, MAY INCREASE REACTIVITY AND ACTIVATE SYMPTOMS SUCH AS HYPERAROUSAL OR DISSOCIATION. THIS ARTICLE REPORTS ON EXPERT INPUT ABOUT ADAPTING YOGA FOR INDIVIDUALS WITH TRAUMA, WITH SPECIAL CONSIDERATIONS FOR MILITARY POPULATIONS. ELEVEN EXPERTS, RECRUITED BASED ON LITERATURE REVIEW AND REFERRALS, WERE INTERVIEWED IN PERSON OR VIA TELEPHONE AND ASKED SEVEN QUESTIONS ABOUT TRAUMA-INFORMED YOGA. VERBATIM TRANSCRIPTS WERE SUBJECTED TO OPEN-CODING THEMATIC ANALYSIS AND A PRIORI THEMES. FINDINGS REVEALED THAT TIY NEEDS TO EMPHASIZE BENEFICIAL PRACTICES (E.G., DIAPHRAGMATIC BREATH AND RESTORATIVE POSTURES), CONSIDER CONTRAINDICATIONS (E.G., AVOIDING SEQUENCES THAT OVERLY ENGAGE THE SYMPATHETIC NERVOUS SYSTEM), ADAPT TO LIMITATIONS AND CHALLENGES FOR TEACHING IN UNCONVENTIONAL SETTINGS (E.G., PRISONS, VA HOSPITALS), AND PROVIDE SPECIALIZED TRAINING AND PREPARATION (E.G., SPECIALIZED TIY CERTIFICATIONS, SELF-CARE OF INSTRUCTORS/THERAPISTS, ADAPTIONS FOR STUDENT NEEDS). TIY FOR VETERANS MUST ADDITIONALLY CONSIDER GENDER- AND CULTURE-RELATED BARRIERS, DIFFERING RELATIONSHIPS TO PAIN AND INJURY, AND MEDICATION AS A BARRIER TO PRACTICE. 2018 19 172 43 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 20 1903 53 RESULTS FROM A CLINICAL YOGA PROGRAM FOR VETERANS: YOGA VIA TELEHEALTH PROVIDES COMPARABLE SATISFACTION AND HEALTH IMPROVEMENTS TO IN-PERSON YOGA. BACKGROUND: YOGA IS INCREASINGLY POPULAR, THOUGH LITTLE DATA REGARDING ITS IMPLEMENTATION IN HEALTHCARE SETTINGS IS AVAILABLE. SIMILARLY, TELEHEALTH IS BEING UTILIZED MORE FREQUENTLY TO INCREASE ACCESS TO HEALTHCARE; HOWEVER WE KNOW OF NO RESEARCH ON THE ACCEPTABILITY OR EFFECTIVENESS OF YOGA DELIVERED THROUGH TELEHEALTH. THEREFORE, WE EVALUATED THE FEASIBILITY, ACCEPTABILITY, AND PATIENT-REPORTED EFFECTIVENESS OF A CLINICAL YOGA PROGRAM AT A VETERANS AFFAIRS MEDICAL CENTER AND ASSESSED WHETHER THESE OUTCOMES DIFFERED BETWEEN THOSE PARTICIPATING IN-PERSON AND THOSE PARTICIPATING VIA TELEHEALTH. METHODS: VETERANS WHO ATTENDED A YOGA CLASS AT THE VA PALO ALTO HEALTH CARE SYSTEM WERE INVITED TO COMPLETE AN ANONYMOUS PROGRAM EVALUATION SURVEY. RESULTS: 64 VETERANS COMPLETED THE SURVEY. PARTICIPANTS REPORTED HIGH SATISFACTION WITH THE CLASSES AND THE INSTRUCTORS. MORE THAN 80% OF PARTICIPANTS WHO ENDORSED A PROBLEM WITH PAIN, ENERGY LEVEL, DEPRESSION, OR ANXIETY REPORTED IMPROVEMENT IN THESE SYMPTOMS. THOSE WHO PARTICIPATED VIA TELEHEALTH DID NOT DIFFER FROM THOSE WHO PARTICIPATED IN-PERSON IN ANY MEASURE OF SATISFACTION, OVERALL IMPROVEMENT (P = .40), OR IMPROVEMENT IN ANY OF 16 SPECIFIC HEALTH PROBLEMS. CONCLUSIONS: DELIVERING YOGA TO A WIDE RANGE OF PATIENTS WITHIN A HEALTHCARE SETTING APPEARS TO BE FEASIBLE AND ACCEPTABLE, BOTH WHEN DELIVERED IN-PERSON AND VIA TELEHEALTH. PATIENTS IN THIS CLINICAL YOGA PROGRAM REPORTED HIGH LEVELS OF SATISFACTION AND IMPROVEMENT IN MULTIPLE PROBLEM AREAS. THIS PRELIMINARY EVIDENCE FOR THE EFFECTIVENESS OF A CLINICAL YOGA PROGRAM COMPLEMENTS PRIOR EVIDENCE FOR THE EFFICACY OF YOGA AND SUPPORTS THE USE OF YOGA IN HEALTHCARE SETTINGS. 2017