1 1237 163 FEASIBILITY OF A BRIEF YOGA INTERVENTION FOR IMPROVING ACUTE PAIN AND DISTRESS POST GYNECOLOGIC SURGERY. BACKGROUND: WOMEN UNDERGOING SURGICAL PROCEDURES FOR SUSPECTED GYNECOLOGIC MALIGNANCIES FREQUENTLY EXPERIENCE PAIN AND PSYCHOLOGICAL DISTRESS RELATED TO SURGERY. YOGA MAY REDUCE THESE NEGATIVE SURGICAL OUTCOMES. THE PRIMARY OBJECTIVE OF THIS PILOT STUDY WAS TO ASSESS THE FEASIBILITY OF EVALUATING A PERIOPERATIVE BRIEF YOGA SKILLS TRAINING (YST) IN THIS POPULATION. SECONDARY OBJECTIVES WERE TO (1) ASSESS THE IMMEDIATE EFFECTS OF THE YST ON PAIN AND PSYCHOLOGICAL DISTRESS; AND (2) PROVIDE PRELIMINARY DATA FOR FUTURE STUDIES. METHOD: ADULT WOMEN SCHEDULED TO UNDERGO AN EXPLORATORY LAPAROTOMY FOR A SUSPECTED GYNECOLOGIC MALIGNANCY WERE RECRUITED TO THIS ONE-ARM FEASIBILITY STUDY. EACH WOMAN RECEIVED THE YST, WHICH CONSISTED OF THREE 15-MINUTE SESSIONS, ONE BEFORE AND TWO AFTER SURGERY. THE FOLLOWING CONSTRUCTS WERE ASSESSED: FEASIBILITY (RATES OF ACCRUAL, INTERVENTION ADHERENCE, MEASURE COMPLETION, RETENTION, AND LEVEL OF SATISFACTION), IMMEDIATE EFFECTS OF THE YST (VISUAL ANALOGUE SCALE RATINGS OF PAIN AND DISTRESS IMMEDIATELY BEFORE AND AFTER EACH SESSION), AND DESCRIPTIVE STATISTICS FOR MEASURES TO BE USED IN FUTURE STUDIES. RESULTS: OF THE 33 ELIGIBLE WOMEN, 18 WERE APPROACHED AND 10 AGREED TO PARTICIPATE (MEAN AGE = 54.7 YEARS; 90% WHITE). TWO WOMEN DISCONTINUED THE STUDY PRIOR TO STARTING THE YST SESSIONS. OF THE EIGHT PARTICIPANTS WHO RECEIVED THE YST, FIVE COMPLETED THE PRE-SURGERY SESSION (63%) AND SEVEN COMPLETED (88%) BOTH POST-SURGICAL SESSIONS; ONE WOMAN WITHDREW AFTER ONE YST SESSION. PARTICIPANTS REPORTED HIGH SATISFACTION WITH THE YST. ACUTE PAIN AND DISTRESS DECREASED FROM BEFORE TO IMMEDIATELY AFTER THE YST SESSION WITH MODERATE TO LARGE EFFECTS: PAIN, D'S = -0.67 TO -0.95; DISTRESS, D'S = -0.66 TO -1.08. CONCLUSIONS: THIS STUDY DEMONSTRATED REASONABLE INDICATORS OF FEASIBILITY. IN ADDITION, PATIENTS SHOWED SHORT-TERM REDUCTIONS IN PAIN AND DISTRESS. NEXT STEPS INCLUDE ATTENTION TO IMPROVING STAFF AVAILABILITY AND INTERVENTION IMPLEMENTATION IN ORDER TO FEASIBLY EVALUATE THE PERIOPERATIVE YST, WHICH SHOWS PROMISE FOR REDUCING POSTOPERATIVE PAIN AND DISTRESS. 2016
2 2550 43 YOGA FOR CANCER-RELATED FATIGUE IN SURVIVORS OF HEMATOPOIETIC CELL TRANSPLANTATION: A FEASIBILITY STUDY. CONTEXT: CANCER-RELATED FATIGUE (CRF) IS ONE OF THE MOST COMMON SYMPTOMS EXPERIENCED BY CANCER PATIENTS AFTER HEMATOPOIETIC CELL TRANSPLANTATION (HCT). YOGA IS AN APPROACH WITH SUPPORTIVE EVIDENCE TO IMPROVE CRF IN DIFFERENT CANCER POPULATIONS, BUT TO OUR KNOWLEDGE, IT HAS NOT BEEN TESTED IN AN ADULT HCT POPULATION. OBJECTIVES: THE AIM OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY OF A YOGA INTERVENTION OFFERED TO ADULT HCT SURVIVORS WITH MODERATE-TO-SEVERE CRF. METHODS: THIS FEASIBILITY STUDY USED A SINGLE-ARM, PRETEST-POSTTEST DESIGN. ADULT HCT SURVIVORS WERE ENROLLED IN A SIX-WEEK RESTORATIVE YOGA INTERVENTION THAT CONSISTED OF A ONE-HOUR ONCE-WEEKLY CLASS WITH TWICE-WEEKLY HOME PRACTICE USING A DVD. RESULTS: TWENTY PARTICIPANTS (13 WOMEN AND SEVEN MEN) ENROLLED IN THIS STUDY WITH A MEAN AGE OF 51 YEARS (SD = 12.5). THE SAMPLE CONSISTED OF 19 ALLOGENEIC HCT SURVIVORS, SEVEN OF WHOM HAD A HISTORY OF ACUTE GRAFT-VS.-HOST DISEASE (GVHD), SIX WITH ACTIVE, EXTENSIVE CHRONIC GVHD, AND ONE AUTOLOGOUS HCT SURVIVOR. THE ACCRUAL ACCEPTANCE RATE WAS 23.2% (20/86 HCT SURVIVORS) AND RETENTION RATE WAS 60% (12/20). OVERALL ADHERENCE WAS 45.4%. NO ADVERSE EVENTS WERE REPORTED. CONCLUSION: THE RESULTS OF THIS STUDY SUGGEST THAT A RESTORATIVE YOGA INTERVENTION IN ADULT HCT SURVIVORS IS SAFE AND FEASIBLE. THE INCIDENCE OF GVHD MAY HAVE IMPACTED ADHERENCE. STRATEGIES TO IMPROVE ACCRUAL ACCEPTANCE, RETENTION, AND ADHERENCE ARE NEEDED. 2020
3 41 57 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
4 172 44 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
5 1240 47 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
6 71 35 A FEASIBILITY STUDY OF RESTORATIVE YOGA VERSUS VIGOROUS YOGA INTERVENTION FOR SEDENTARY BREAST AND OVARIAN CANCER SURVIVORS. YOGA HAS BEEN SHOWN TO IMPROVE CANCER SURVIVORS' QUALITY OF LIFE, YET REGULAR YOGA PRACTICE IS A CHALLENGE FOR THOSE WHO ARE SEDENTARY. WE CONDUCTED A PILOT RANDOMIZED CONTROLLED STUDY TO ASSESS FEASIBILITY AND ADHERENCE OF TWO TYPES OF YOGA INTERVENTION AMONG SEDENTARY CANCER SURVIVORS. SEDENTARY BREAST AND OVARIAN CANCER SURVIVORS WERE RANDOMIZED TO PRACTICE EITHER RESTORATIVE YOGA (MINIMAL PHYSICAL EXERTION, GROUP R) OR VIGOROUS YOGA (CONSIDERABLE PHYSICAL EXERTION, GROUP V) IN THREE 60-MINUTE SUPERVISED SESSIONS A WEEK FOR 12 WEEKS, FOLLOWED BY 12 WEEKS OF HOME PRACTICE. ACCRUAL, ADHERENCE, AND ATTENDANCE RATES WERE ASSESSED. OF THE 226 ELIGIBLE PATIENTS, 175 (77%) DECLINED TO PARTICIPATE IN THE STUDY, CITING TIME COMMITMENT AND TRAVEL AS THE MOST COMMON BARRIERS. FORTY-TWO SUBJECTS CONSENTED TO PARTICIPATE IN THE STUDY. OF THE 35 PARTICIPANTS WHO BEGAN THE INTERVENTION (20 IN GROUP R AND 15 IN GROUP V), ADHERENCE RATE (PERCENTAGE REMAINING IN THE STUDY AT WEEK 12) WAS 100% AND 87%, RESPECTIVELY. RATE OF ADEQUATE ATTENDANCE (MORE THAN 66% OF THE SCHEDULED SUPERVISED SESSIONS) WAS 85% AND 73%, RESPECTIVELY. RATE OF COMPLETION OF THE HOME PRACTICE PERIOD WAS 85% AND 77%, RESPECTIVELY. IN THIS STUDY, SEDENTARY CANCER SURVIVORS WERE ABLE TO ADHERE TO A LONG-TERM, REGULAR YOGA REGIMEN. THE RATE OF ADEQUATE ATTENDANCE WAS HIGHER FOR RESTORATIVE YOGA. FUTURE STUDIES FOR SEDENTARY PATIENTS SHOULD FOCUS ON REDUCING TIME COMMITMENT AND TRAVEL REQUIREMENTS TO IMPROVE RECRUITMENT, AND ON USING RESTORATIVE YOGA AS A MORE FEASIBLE INTERVENTION FOR THIS POPULATION. 2018
7 551 45 CONVENIENT AND LIVE MOVEMENT (CALM) FOR WOMEN UNDERGOING BREAST CANCER TREATMENT: CHALLENGES AND RECOMMENDATIONS FOR INTERNET-BASED YOGA RESEARCH. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF INTERNET-BASED, CANCER-ADAPTED YOGA FOR WOMEN RECEIVING BREAST CANCER TREATMENT. DESIGN: WOMEN UNDERGOING RADIATION OR CHEMOTHERAPY FOR BREAST CANCER WERE RECRUITED FOR 12, 75-MIN, BIWEEKLY, CANCER-ADAPTED YOGA CLASSES DELIVERED VIA INTERNET-BASED, MULTIPOINT VIDEOCONFERENCING. DATA WERE COLLECTED ON FEASIBILITY AND ACCEPTABILITY, INCLUDING QUALITATIVE FEEDBACK FROM PARTICIPANTS AND THE YOGA INSTRUCTOR. RESULTS: AMONG 42 WOMEN APPROACHED, 13 DECLINED ELIGIBILITY SCREENING, AND 23 WERE INELIGIBLE. ALL 6 WOMEN WHO WERE ELIGIBLE PROVIDED CONSENT, BUT 2 WITHDREW PRIOR TO BEGINNING YOGA CLASSES. THE REMAINING 4 PARTICIPANTS ATTENDED 1-11 OF 12 ONLINE YOGA CLASSES. IN POST-INTERVENTION INTERVIEWS, PARTICIPANTS AND THE INSTRUCTOR AGREED THAT INTERNET-BASED YOGA CLASSES HOLD GREAT POTENTIAL FOR INCREASING ACCESS AND IMPROVING PSYCHOLOGICAL OUTCOMES IN ADULTS WITH CANCER. QUALITATIVE FEEDBACK FROM PARTICIPANTS REVEALED SUGGESTIONS FOR FUTURE TRIALS OF INTERNET-BASED, CANCER-ADAPTED YOGA CLASSES, INCLUDING: CONTINUED USE OF GROUP FORMAT; OFFERING MORE VARIED CLASS TIMES TO ACCOMMODATE PATIENTS' DEMANDING SCHEDULES AND FLUCTUATING SYMPTOMS; ENROLLING PATIENTS AFTER THEY HAVE ACCLIMATED TO OR COMPLETED CANCER TREATMENT; STREAMLINING THE TECHNOLOGY INTERFACE; AND CAREFUL ATTENTION TO PARTICIPANT BURDEN WHEN DESIGNING SURVEYS/FORMS. THE INSTRUCTOR RECOMMENDED CLOSED SESSION COURSES, AS OPPOSED TO ROLLING ENROLLMENT; TEACHING THE SAME MODIFIED POSES FOR ALL PARTICIPANTS, RATHER THAN INDIVIDUAL TAILORING; AND USING A LARGE SCREEN TO ALLOW CLOSER MONITORING OF STUDENTS' CLASS EXPERIENCE. CONCLUSIONS: INTERNET DELIVERY MAY INCREASE PATIENTS' ACCESS TO CANCER-ADAPTED YOGA CLASSES, BUT CANCER-RELATED AND TECHNOLOGICAL BARRIERS REMAIN. THIS STUDY INFORMS HOW TO OPTIMALLY DESIGN YOGA CLASSES, TECHNOLOGY, AND RESEARCH PROCEDURES TO MAXIMIZE FEASIBILITY AND ACCEPTABILITY IN FUTURE TRIALS. 2018
8 1245 45 FEASIBILITY OF IMPLEMENTING A COMMUNITY-BASED RANDOMIZED TRIAL OF YOGA FOR WOMEN UNDERGOING CHEMOTHERAPY FOR BREAST CANCER. BACKGROUND: TREATMENT-RELATED SYMPTOMS AND DECREASED HEALTH-RELATED QUALITY OF LIFE (HRQOL) FREQUENTLY OCCUR DURING CHEMOTHERAPY FOR BREAST CANCER. ALTHOUGH RESEARCH FINDINGS SUGGEST THAT YOGA CAN REDUCE SYMPTOMS AND IMPROVE HRQOL AFTER TREATMENT, POTENTIAL BENEFITS OF YOGA DURING CHEMOTHERAPY HAVE RECEIVED MINIMAL ATTENTION. OBJECTIVE: TO ESTIMATE ACCRUAL, ADHERENCE, STUDY RETENTION, AND PRELIMINARY EFFICACY OF A YOGA INTERVENTION COMPARED WITH AN ACTIVE CONTROL GROUP FOR BREAST CANCER PATIENTS DURING CHEMOTHERAPY. METHODS: WOMEN WITH STAGE I-III BREAST CANCER WERE RECRUITED FROM 3 COMMUNITY CANCER CLINICS AND RANDOMIZED TO 10 WEEKS OF GENTLE YOGA OR WELLNESS EDUCATION. DEPRESSIVE SYMPTOMS, FATIGUE, SLEEP, AND HRQOL WERE ASSESSED AT BASELINE, MID-INTERVENTION (WEEK 5), AND AFTER INTERVENTION (WEEK 10). RESULTS: 40 WOMEN AGED 29-83 YEARS (MEDIAN, 48 YEARS; 88% WHITE) WERE RANDOMIZED TO YOGA (N = 22) OR WELLNESS EDUCATION (N = 18). THE GROUPS DID NOT DIFFER SIGNIFICANTLY ON BASELINE CHARACTERISTICS, ADHERENCE, OR STUDY RETENTION. PARTICIPANT FEEDBACK WAS POSITIVE AND COMPARABLE BETWEEN GROUPS. MEANINGFUL WITHIN-GROUP DIFFERENCES WERE IDENTIFIED FOR SLEEP ADEQUACY AND QUANTITY IN YOGA PARTICIPANTS AND FOR SOMNOLENCE IN WELLNESS-EDUCATION PARTICIPANTS. LIMITATIONS: SMALL SAMPLE SIZE AND LACK OF A USUAL-CARE CONTROL GROUP. CONCLUSIONS: THIS STUDY ESTABLISHED FEASIBILITY OF A COMMUNITY-BASED RANDOMIZED TRIAL OF YOGA AND AN ACTIVE COMPARISON GROUP FOR WOMEN UNDERGOING CHEMOTHERAPY FOR BREAST CANCER. PRELIMINARY EFFICACY ESTIMATES SUGGEST THAT YOGA IMPROVES SLEEP ADEQUACY SYMPTOM SEVERITY AND INTERFERENCE REMAINED STABLE DURING CHEMOTHERAPY FOR THE YOGA GROUP AND SNOWED A TREND TOWARD INCREASING IN THE CONTROL GROUP. THE STUDY HIGHLIGHTED OBSTACLES TO MULTISITE YOGA RESEARCH DURING CANCER TREATMENT. FUNDING/SPONSORSHIP: NATIONAL CANCER INSTITUTE (3U10 CA081851, PI; SHAW; R25 CA122061, PI: AVIS); TRANSLATIONAL SCIENCE INSTITUTE, WAKE FOREST SCHOOL OF MEDICINE. 2015
9 1495 37 INTERVENTION PROTOCOL FOR INVESTIGATING YOGA IMPLEMENTED DURING CHEMOTHERAPY. OBJECTIVE: FATIGUE AND OTHER TREATMENT-RELATED SYMPTOMS ARE CRITICAL THERAPEUTIC TARGETS FOR IMPROVING QUALITY OF LIFE IN PATIENTS WITH COLORECTAL CANCER DURING CHEMOTHERAPY. YOGA IS A PROMISING INTERVENTION FOR IMPROVING THESE THERAPEUTIC TARGETS AND HAS BEEN PRIMARILY INVESTIGATED IN THE GROUP-CLASS FORMAT, WHICH IS LESS FEASIBLE FOR CANCER PATIENTS WITH HIGH SYMPTOM BURDEN TO ATTEND. THUS, WE DEVELOPED A PROTOCOL FOR IMPLEMENTING YOGA INDIVIDUALLY IN THE CLINIC AMONG PATIENTS RECEIVING CHEMOTHERAPY. METHODS: WE FOLLOWED RECOMMENDED DOMAINS FOR DEVELOPING A YOGA PROTOCOL TO BE USED IN AN EFFICACY TRIAL. THESE RECOMMENDATIONS INCLUDE CONSIDERATION TO THE STYLE, DELIVERY, COMPONENTS OF THE INTERVENTION, DOSE, SPECIFIC CLASS SEQUENCES, FACILITATION OF HOME PRACTICE, MEASUREMENT OF INTERVENTION FIDELITY, SELECTION OF INSTRUCTORS, AND DEALING WITH MODIFICATIONS. THE INTERVENTION PROTOCOL WAS DEVELOPED BY AN INTERDISCIPLINARY TEAM. PROTOCOL: YOGA SKILLS TRAINING (YST) CONSISTS OF FOUR 30-MINUTE IN-PERSON SESSIONS AND WAS IMPLEMENTED WHILE IN THE CHAIR DURING CHEMOTHERAPY INFUSIONS FOR COLORECTAL CANCER WITH RECOMMENDED DAILY HOME PRACTICE FOR EIGHT WEEKS. THERAPEUTIC GOALS OF THE YST ARE TO REDUCE FATIGUE, CIRCADIAN DISRUPTION, AND PSYCHOLOGICAL DISTRESS. ELEMENTS OF THE YST ARE AWARENESS MEDITATION, GENTLE SEATED MOVEMENT, BREATHING PRACTICE, AND RELAXATION MEDITATION. ATTENTION, COMFORT, AND EASE ARE ALSO HIGHLIGHTED. CONCLUSION: THIS DESCRIPTION OF A PROTOCOL FOR INTEGRATING YOGA WITH CONVENTIONAL CANCER TREATMENT WILL INFORM FUTURE STUDY DESIGNS AND CLINICAL PRACTICE. THE DESIGN OF THE YST IS NOVEL BECAUSE IT IMPLEMENTS YOGA-MOST COMMONLY STUDIED WHEN TAUGHT TO GROUPS OUTSIDE OF THE CLINICAL SETTING- INDIVIDUALLY DURING CLINICAL CARE. 2016
10 201 38 A RESTORATIVE YOGA INTERVENTION FOR AFRICAN-AMERICAN BREAST CANCER SURVIVORS: A PILOT STUDY. BACKGROUND: DATA SHOW THAT YOGA IS EFFECTIVE FOR IMPROVING HEALTH-RELATED OUTCOMES IN BREAST CANCER SURVIVORS. WHILE BREAST CANCER IS THE MOST COMMONLY DIAGNOSED CANCER AMONG AFRICAN-AMERICAN WOMEN (AAW), AAW ARE LESS LIKELY TO ENGAGE IN YOGA COMPARED TO OTHER ETHNIC GROUPS. THE GOALS OF THE CURRENT STUDY WERE TO ASSESS THE FEASIBILITY OF AN 8-WEEK RESTORATIVE YOGA PROGRAM AMONG AFRICAN-AMERICAN BREAST CANCER SURVIVORS (AA BCS). SPECIFICALLY, STUDY AIMS WERE TO (1) MEASURE CHANGES IN STUDY OUTCOMES IN A RESTORATIVE YOGA (RY) GROUP COMPARED TO A WAIT LIST CONTROL GROUP, (2) ASSESS ADHERENCE TO THE RY PROGRAM, AND (3) ASSESS PROGRAM SATISFACTION AMONG STUDY PARTICIPANTS. METHODS: THIRTY-THREE AA BCS WERE RANDOMLY ASSIGNED TO EITHER THE RY INTERVENTION (N = 18) OR WAIT LIST CONTROL GROUP (N = 15). RY CLASSES MET ONCE PER WEEK FOR 8 WEEKS. PRE- AND POST-TESTING ASSESSMENTS WERE MEASURED AT 0 AND 8 WEEKS (IMMEDIATELY POST-INTERVENTION). RESULTS: DEPRESSION SCORES AT FOLLOW-UP WERE SIGNIFICANTLY LOWER IN THE YOGA GROUP (M = 4.78, SD = 3.56) COMPARED TO THE CONTROL GROUP (M = 6.91, SD = 5.86). NO SIGNIFICANT GROUP DIFFERENCES WERE OBSERVED FOR SLEEP QUALITY, FATIGUE, OR PERCEIVED STRESS. YOGA PROGRAM PARTICIPANTS COMPLETING BASELINE ASSESSMENTS DEMONSTRATED 61% ADHERENCE TO THE YOGA CLASSES. AVERAGE RATING OF THE YOGA PROGRAM WAS "VERY USEFUL." RECOMMENDATIONS FOR FUTURE YOGA PROGRAMS WERE PROVIDED. CONCLUSIONS: THIS STUDY SUGGESTS THAT YOGA HAS A BENEFICIAL EFFECT ON DEPRESSION IN AA BCS. THERE IS, HOWEVER, A NEED TO FURTHER EXPLORE THE BENEFITS OF YOGA AMONG MINORITY BREAST CANCER SURVIVORS USING A STUDY WITH LARGER SAMPLE SIZES. 2018
11 312 43 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
12 945 43 EFFECTS OF A 12-WEEK YOGA VERSUS A 12-WEEK EDUCATIONAL FILM INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME AND RELATED OUTCOMES: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL. STUDY OBJECTIVES: TO ASSESS THE EFFECTS OF A YOGA VERSUS EDUCATIONAL FILM (EF) PROGRAM ON RESTLESS LEGS SYNDROME (RLS) SYMPTOMS AND RELATED OUTCOMES IN ADULTS WITH RLS. METHODS: FORTY-ONE COMMUNITY-DWELLING, AMBULATORY NONPREGNANT ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EF PROGRAM (N = 22). IN ADDITION TO ATTENDING CLASSES, ALL PARTICIPANTS COMPLETED PRACTICE/TREATMENT LOGS. YOGA GROUP PARTICIPANTS WERE ASKED TO PRACTICE AT HOME 30 MINUTES PER DAY ON NONCLASS DAYS; EF PARTICIPANTS WERE INSTRUCTED TO RECORD ANY RLS TREATMENTS USED ON THEIR DAILY LOGS. CORE OUTCOMES ASSESSED PRETREATMENT AND POSTTREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS STUDY GROUP SCALE (IRLS) AND RLS ORDINAL SCALE), SLEEP QUALITY, MOOD, PERCEIVED STRESS, AND QUALITY OF LIFE (QOL). RESULTS: THIRTY ADULTS (13 YOGA, 17 EF), AGED 24 TO 73 (MEAN = 50.4 +/- 2.4 YEARS), COMPLETED THE 12-WEEK STUDY (78% FEMALE, 80.5% WHITE). POST-INTERVENTION, BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN RLS SYMPTOMS AND SEVERITY, PERCEIVED STRESS, MOOD, AND QOL-MENTAL HEALTH (P </= .04). RELATIVE TO THE EF GROUP, YOGA PARTICIPANTS DEMONSTRATED SIGNIFICANTLY GREATER REDUCTIONS IN RLS SYMPTOMS AND SYMPTOM SEVERITY (P </= .01), AND GREATER IMPROVEMENTS IN PERCEIVED STRESS AND MOOD (P </= .04), AS WELL AS SLEEP QUALITY (P = .09); RLS SYMPTOMS DECREASED TO MINIMAL/MILD IN 77% OF YOGA GROUP PARTICIPANTS, WITH NONE SCORING IN THE SEVERE RANGE BY WEEK 12, VERSUS 24% AND 12%, RESPECTIVELY, IN EF PARTICIPANTS. IN THE YOGA GROUP, IRLS AND RLS SEVERITY SCORES DECLINED WITH INCREASING MINUTES OF HOMEWORK PRACTICE (R = .7, P = .009 AND R = .6, P = .03, RESPECTIVELY), SUGGESTING A POSSIBLE DOSE-RESPONSE RELATIONSHIP. CONCLUSIONS: FINDINGS OF THIS EXPLORATORY RCT SUGGEST THAT YOGA MAY BE EFFECTIVE IN REDUCING RLS SYMPTOMS AND SYMPTOM SEVERITY, DECREASING PERCEIVED STRESS, AND IMPROVING MOOD AND SLEEP IN ADULTS WITH RLS. CLINICAL TRIAL REGISTRATION: REGISTRY: CLINICALTRIALS.GOV; TITLE: YOGA VS. EDUCATION FOR RESTLESS LEGS: A FEASIBILITY STUDY; IDENTIFIER: NCT03570515; URL: HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03570515. 2020
13 258 42 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
14 1865 40 RANDOMIZED PILOT TRIAL OF YOGA VERSUS STRENGTHENING EXERCISES IN BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE. PURPOSE: FATIGUE IS ONE OF THE MOST COMMON AND BOTHERSOME REFRACTORY SYMPTOMS EXPERIENCED BY CANCER SURVIVORS. MINDFUL EXERCISE INTERVENTIONS SUCH AS YOGA IMPROVE CANCER-RELATED FATIGUE; HOWEVER, STUDIES OF YOGA HAVE INCLUDED HETEROGENEOUS SURVIVORSHIP POPULATIONS, AND THE EFFECT OF YOGA ON FATIGUED SURVIVORS REMAINS UNCLEAR. METHODS: WE RANDOMLY ASSIGNED 34 EARLY-STAGE BREAST CANCER SURVIVORS WITH CANCER-RELATED FATIGUE (>/=4 ON A LIKERT SCALE FROM 1-10) WITHIN 1 YEAR FROM DIAGNOSIS TO A 12-WEEK INTERVENTION OF HOME-BASED YOGA VERSUS STRENGTHENING EXERCISES, BOTH PRESENTED ON A DVD. THE PRIMARY ENDPOINTS WERE FEASIBILITY AND CHANGES IN FATIGUE, AS MEASURED BY THE MULTIDIMENSIONAL FATIGUE SYMPTOM INVENTORY-SHORT FORM (MFSI-SF). SECONDARY ENDPOINT WAS QUALITY OF LIFE, ASSESSED BY THE FUNCTIONAL ASSESSMENT OF CANCER THERAPIES-BREAST (FACT-B). RESULTS: WE INVITED 401 WOMEN TO PARTICIPATE IN THE STUDY; 78 RESPONDED, AND WE ENROLLED 34. BOTH GROUPS HAD SIGNIFICANT WITHIN-GROUP IMPROVEMENT IN MULTIPLE DOMAINS OF THE FATIGUE AND QUALITY OF LIFE SCORES FROM BASELINE TO POST-INTERVENTION, AND THESE BENEFITS WERE MAINTAINED AT 3 MONTHS POST-INTERVENTION. HOWEVER, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS IN FATIGUE OR QUALITY OF LIFE AT ANY ASSESSMENT TIME. SIMILARLY, THERE WAS NO DIFFERENCE BETWEEN GROUPS IN ADHERENCE TO THE EXERCISE INTERVENTION. CONCLUSIONS: BOTH DVD-BASED YOGA AND STRENGTHENING EXERCISES DESIGNED FOR CANCER SURVIVORS MAY BE GOOD OPTIONS TO ADDRESS FATIGUE IN BREAST CANCER SURVIVORS. BOTH HAVE REASONABLE UPTAKE, ARE CONVENIENT AND REPRODUCIBLE, AND MAY BE HELPFUL IN DECREASING FATIGUE AND IMPROVING QUALITY OF LIFE IN THE FIRST YEAR POST-DIAGNOSIS IN BREAST CANCER PATIENTS WITH CANCER-RELATED FATIGUE. 2016
15 1331 41 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
16 70 43 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
17 1900 43 RESTORATIVE YOGA FOR WOMEN WITH BREAST CANCER: FINDINGS FROM A RANDOMIZED PILOT STUDY. OBJECTIVES: RESTORATIVE YOGA (RY) IS A GENTLE TYPE OF YOGA THAT MAY BE BENEFICIAL FOR CANCER PATIENTS AND POST-TREATMENT SURVIVORS. STUDY GOALS WERE: TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A RY INTERVENTION FOR WOMEN WITH BREAST CANCER; AND TO EXAMINE GROUP DIFFERENCES IN SELF-REPORTED EMOTIONAL, HEALTH-RELATED QUALITY OF LIFE, AND SYMPTOM OUTCOMES. METHODS: WOMEN WITH BREAST CANCER (N=44; MEAN AGE 55.8 YEARS) ENROLLED IN THIS STUDY; 34% WERE ACTIVELY UNDERGOING CANCER TREATMENT. STUDY PARTICIPANTS WERE RANDOMIZED TO THE INTERVENTION (10 WEEKLY 75-MINUTE RY CLASSES) OR A WAITLIST CONTROL GROUP. PARTICIPANTS COMPLETED QUESTIONNAIRES AT WEEK 0 (BASELINE) AND WEEK 10 (IMMEDIATELY POST-INTERVENTION FOR THE YOGA GROUP). RESULTS: GROUP DIFFERENCES FAVORING THE YOGA GROUP WERE SEEN FOR MENTAL HEALTH, DEPRESSION, POSITIVE AFFECT, AND SPIRITUALITY (PEACE/MEANING). SIGNIFICANT BASELINE*GROUP INTERACTIONS WERE OBSERVED FOR NEGATIVE AFFECT AND EMOTIONAL WELL-BEING. WOMEN WITH HIGHER NEGATIVE AFFECT AND LOWER EMOTIONAL WELL-BEING AT BASELINE DERIVED GREATER BENEFIT FROM THE YOGA INTERVENTION COMPARED TO THOSE WITH SIMILAR VALUES AT BASELINE IN THE CONTROL GROUP. THE YOGA GROUP DEMONSTRATED A SIGNIFICANT WITHIN-GROUP IMPROVEMENT IN FATIGUE; NO SIGNIFICANT DIFFERENCE WAS NOTED FOR THE CONTROL GROUP. CONCLUSIONS: ALTHOUGH LIMITED BY SAMPLE SIZE, THESE PILOT DATA SUGGEST POTENTIAL BENEFIT OF RY ON EMOTIONAL OUTCOMES AND FATIGUE IN CANCER PATIENTS. THIS STUDY DEMONSTRATES THAT A RY INTERVENTION IS FEASIBLE FOR WOMEN WITH BREAST CANCER; IMPLICATIONS FOR STUDY DESIGN AND IMPLEMENTATION ARE NOTED WITH AN EMPHASIS ON PROGRAM ADOPTION AND PARTICIPANT ADHERENCE. 2009
18 1748 42 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
19 127 38 A PILOT STUDY TO EVALUATE THE FEASIBILITY OF INDIVIDUALIZED YOGA FOR INPATIENT CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. BACKGROUND: FATIGUE IS AN IMPORTANT PROBLEM IN PAEDIATRIC CANCER PATIENTS AND YOGA MAY BE AN EFFECTIVE INTERVENTION. THE PRIMARY OBJECTIVE WAS TO DETERMINE THE FEASIBILITY OF INDIVIDUALIZED YOGA FOR HOSPITALIZED CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. METHODS: WE INCLUDED ENGLISH-SPEAKING CHILDREN AND ADOLESCENTS AGED 7-18 YEARS RECEIVING INTENSIVE CHEMOTHERAPY OR HAEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT). YOGA WAS CONDUCTED THREE TIMES WEEKLY FOR THREE WEEKS. THE PRIMARY OUTCOME WAS FEASIBILITY, DEFINED AS ABILITY TO DELIVER AT LEAST 60% OF PLANNED SESSIONS. SECONDARY OUTCOMES WERE PARENT-REPORTED PEDIATRIC QUALITY OF LIFE INVENTORY (PEDSQL) MULTIDIMENSIONAL FATIGUE SCALE, FATIGUE SCALE-PARENT, PEDSQL GENERIC CORE SCALES AND PEDSQL ACUTE CANCER MODULE. RESULTS: BETWEEN JANUARY AND OCTOBER 2013, 11 PATIENTS WERE ENROLLED. MEDIAN AGE WAS 14.0 (RANGE 7.7-16.4) YEARS AND 6 (55%) WERE BOYS. YOGA WAS FEASIBLE WITH 10/11 PARTICIPANTS MEETING THE THRESHOLD FOR FEASIBILITY. THE MEDIAN NUMBER OF YOGA SESSIONS WAS 9 (RANGE 3-13). NO ADVERSE EVENTS WERE ATTRIBUTED TO YOGA. MEAN+/-STANDARD DEVIATION FOR THE DAY 21 PROXY-REPORTED PEDSQL GENERAL FATIGUE SCORES WAS 55.6+/-15.5. QUALITATIVE COMMENTS SUGGESTED DESIGN CHANGES FOR FUTURE YOGA STUDIES. CONCLUSIONS: INDIVIDUALIZED YOGA IS FEASIBLE FOR INPATIENT CHILDREN RECEIVING INTENSIVE CHEMOTHERAPY. FUTURE WORK WILL INCLUDE DEVELOPMENT AND CONDUCT OF A RANDOMIZED TRIAL FOR FATIGUE AMELIORATION. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02105389. 2015
20 1460 31 INFLUENCE OF YOGA ON CANCER-RELATED FATIGUE AND ON MEDIATIONAL RELATIONSHIPS BETWEEN CHANGES IN SLEEP AND CANCER-RELATED FATIGUE: A NATIONWIDE, MULTICENTER RANDOMIZED CONTROLLED TRIAL OF YOGA IN CANCER SURVIVORS. BACKGROUND: CANCER-RELATED FATIGUE (CRF) OFTEN CO-OCCURS WITH SLEEP DISTURBANCE AND IS ONE OF THE MOST PERVASIVE TOXICITIES RESULTING FROM CANCER AND ITS TREATMENT. WE AND OTHER INVESTIGATORS HAVE PREVIOUSLY REPORTED THAT YOGA THERAPY CAN IMPROVE SLEEP QUALITY IN CANCER PATIENTS AND SURVIVORS. NO NATIONWIDE MULTICENTER PHASE III RANDOMIZED CONTROLLED TRIAL (RCT) HAS INVESTIGATED WHETHER YOGA THERAPY IMPROVES CRF OR WHETHER IMPROVEMENTS IN SLEEP MEDIATE THE EFFECT OF YOGA ON CRF. WE EXAMINED THE EFFECT OF A STANDARDIZED, 4-WEEK, YOGA THERAPY PROGRAM (YOGA FOR CANCER SURVIVORS [YOCAS]) ON CRF AND WHETHER YOCAS-INDUCED CHANGES IN SLEEP MEDIATED CHANGES IN CRF AMONG SURVIVORS. STUDY DESIGN AND METHODS: FOUR HUNDRED TEN CANCER SURVIVORS WERE RECRUITED TO A NATIONWIDE MULTICENTER PHASE III RCT COMPARING THE EFFECT OF YOCAS TO STANDARD SURVIVORSHIP CARE ON CRF AND EXAMINING THE MEDIATING EFFECTS OF CHANGES IN SLEEP, STEMMING FROM YOGA, ON CHANGES IN CRF. CRF WAS ASSESSED BY THE MULTIDIMENSIONAL FATIGUE SYMPTOM INVENTORY. SLEEP WAS ASSESSED VIA THE PITTSBURGH SLEEP QUALITY INDEX. BETWEEN- AND WITHIN-GROUP INTERVENTION EFFECTS ON CRF WERE ASSESSED BY ANALYSIS OF COVARIANCE AND 2-TAILED T TEST, RESPECTIVELY. PATH ANALYSIS WAS USED TO EVALUATE MEDIATION. RESULTS: YOCAS PARTICIPANTS DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS IN CRF COMPARED WITH PARTICIPANTS IN STANDARD SURVIVORSHIP CARE AT POST-INTERVENTION ( P < .01). IMPROVEMENTS IN OVERALL SLEEP QUALITY AND REDUCTIONS IN DAYTIME DYSFUNCTION (EG, EXCESSIVE NAPPING) RESULTING FROM YOGA SIGNIFICANTLY MEDIATED THE EFFECT OF YOGA ON CRF (22% AND 37%, RESPECTIVELY, BOTH P < .01). CONCLUSIONS: YOCAS IS EFFECTIVE FOR TREATING CRF AMONG CANCER SURVIVORS; 22% TO 37% OF THE IMPROVEMENTS IN CRF FROM YOGA THERAPY RESULT FROM IMPROVEMENTS IN SLEEP QUALITY AND DAYTIME DYSFUNCTION. ONCOLOGISTS SHOULD CONSIDER PRESCRIBING YOGA TO CANCER SURVIVORS FOR TREATING CRF AND SLEEP DISTURBANCE. 2019