Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT01324102
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2011-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.moye@va.gov', 'phone': '774-826-3721', 'title': 'Jennifer Moye', 'organization': 'VA Boston Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The goals of this study were modest. A small pilot pre-post randomized trial was completed with a Yoga therapy intervention and a Wait list intervention. Additional studies in larger samples are needed.'}}, 'adverseEventsModule': {'timeFrame': 'We collected "serious adverse event and other (not including serious) adverse event" information from the beginning of the study period to 3 months post study period for a total of 5 months.', 'description': 'During the collection period, two forms were submitted to the Institutional Review Board for review as required. One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza. One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia.', 'eventGroups': [{'id': 'EG000', 'title': 'Yoga Therapy', 'description': 'Received yoga therapy.\n\nOne participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza.', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait List', 'description': 'Received no yoga therapy for 8 weeks while the intervention group received yoga therapy\n\nOne participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia.', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Wait List on Yoga Therapy', 'description': 'Received yoga therapy after an 8 week wait.\n\nNo participants were hospitalized.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Influenza Unrelated Hospitalization', 'notes': 'One participant in the Arm 1, Yoga therapy, age 80, was hospitalized for influenza. The reportable event is hospitalization, hence I am listing an Unrelated Hospitalization for Influenza.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other adverse events'}, {'term': 'Pneumonia Unrelated Hospitalization', 'notes': 'One participant in the Arm 2, Wait list, age 65, was hospitalized for pneumonia. The reportable event is hospitalization, hence I am listing an Unrelated Hospitalization for Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other adverse event'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre Group Values', 'description': 'Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice'}, {'id': 'OG001', 'title': 'Post Group Values', 'description': 'Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice'}], 'classes': [{'title': 'Anxiety within normal limits at start (n=18)', 'categories': [{'measurements': [{'value': '8.90', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '19'}, {'value': '12.26', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '24'}]}]}, {'title': 'Anxiety impaired at start (n=5)', 'categories': [{'measurements': [{'value': '19.80', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '24'}, {'value': '16.80', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '21'}]}]}, {'title': 'Insomnia within normal limits at start (n=16)', 'categories': [{'measurements': [{'value': '12.41', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '13.00', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '30'}]}]}, {'title': 'Insomnia impaired at start (n=7)', 'categories': [{'measurements': [{'value': '23.14', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '30'}, {'value': '18.14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '26'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety.', 'groupDescription': 'Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F=10.25', 'testedNonInferiority': False}, {'pValue': '.056', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia.', 'groupDescription': 'Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Primary outcome is measured at baseline and after the 8 week yoga intervention.', 'description': 'The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a small scale pilot study. Due to small sample size, we did pre-post analysis of the total groups, separated by those with and without initial impairment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Yoga Therapy Intervention', 'description': 'Intervention\n\nYoga therapy received an 8 week 2x weekly Yoga therapy class.'}, {'id': 'FG001', 'title': 'Wait List Control', 'description': 'Wait List control received no intervention for 8 weeks, then joined the yoga group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Yoga groups 3 and 5 (not including pre-randomization group)', 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': 'Yoga group 4 and 6', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants identified through cancer registry who were: diagnosed with cancer (any type) Stage 1-4 within the past three years; received surgery, chemotherapy, or radiation treatment; no psychotic or dementing disorders; and not currently in hospice care.', 'preAssignmentDetails': 'No participants were excluded prior to assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Yoga Therapy Intervention', 'description': 'Intervention: Yoga therapy was 8 week class for two times per week'}, {'id': 'BG001', 'title': 'Wait List Control', 'description': 'Wait List control: The wait list control did not receive an intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Mean', 'categories': [{'measurements': [{'value': '69.42', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '84'}, {'value': '69.42', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '84'}, {'value': '69.42', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'description': 'Adult individuals of any age were permitted, but since most of those diagnosed with cancer are older, the sample is predominantly older.', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'All other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2011-03-04', 'resultsFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2011-03-25', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-20', 'studyFirstPostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.', 'timeFrame': 'Primary outcome is measured at baseline and after the 8 week yoga intervention.', 'description': 'The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neoplasms'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '16374892', 'type': 'BACKGROUND', 'citation': 'Culos-Reed SN, Carlson LE, Daroux LM, Hately-Aldous S. A pilot study of yoga for breast cancer survivors: physical and psychological benefits. Psychooncology. 2006 Oct;15(10):891-7. doi: 10.1002/pon.1021.'}, {'pmid': '18544284', 'type': 'BACKGROUND', 'citation': 'Danhauer SC, Tooze JA, Farmer DF, Campbell CR, McQuellon RP, Barrett R, Miller BE. Restorative yoga for women with ovarian or breast cancer: findings from a pilot study. J Soc Integr Oncol. 2008 Spring;6(2):47-58.'}]}, 'descriptionModule': {'briefSummary': "With advances in the detection and treatment of cancer, there are now 14 million cancer survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration. The mental and physical health consequences of cancer and its treatment may affect a Veteran's functioning and re-integration back into family, work, and daily life. Recent studies suggest that yoga may be an effective intervention for improving both the physical and mental health of individuals after cancer, although this has not been studied in Veterans. This study has three components: (1) Determine factors that increase participation in Yoga by Veterans using individual interviews and focus group; (2) Create a Yoga protocol for Veterans adapted from an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and tolerability; (3) Evaluate the efficacy of Yoga for improving fatigue, insomnia, anxiety, and depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.", 'detailedDescription': "With a 1 and 2 lifetime risk of diagnosis, cancer is a highly prevalent disease. Cancer and its treatment are associated with long term mental and physical side effects that impair physical, vocational, and social role functioning. In order to provide excellent care for Veterans, rehabilitative strategies to improve mental and physical health after cancer treatment need empirical study. The objective of the proposed pilot project is to create a Veterans' Yoga Rehabilitation Program for cancer survivors who receive care in the Veterans Health Administration, that is based on an existing evidence based protocol which is systemically adapted, marketed, and tested in a Veteran population, with 3 aims:\n\nAim 1: Enhancing Acceptability To determine factors that will increase participation in Yoga in Veterans after treatment for cancer, who are primarily male and older than age 60.\n\nAim 2: Adapting to Veterans To create a Yoga protocol by adapting an empirically supported Yoga protocol to the needs of Veterans.\n\nAim 3: Evaluating Efficacy To evaluate the efficacy of the Yoga protocol for improving health related quality of life in four domains, and, to determine if efficacy varies as a function of patient age or pre-existing Post Traumatic Stress Disorder. The long term goal is to develop an evidence based mind-body Yoga intervention to support healing and restore function in Veterans Health Administration patients for use after treatment for cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer treated in the past 3 years\n\nExclusion Criteria:\n\n* Dementia\n* Psychotic Disorder\n* In hospice care'}, 'identificationModule': {'nctId': 'NCT01324102', 'acronym': 'YogaCares', 'briefTitle': 'Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Yoga Cancer Rehabilitation Study', 'orgStudyIdInfo': {'id': 'D7629-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. Yoga therapy', 'description': 'The intervention is an 8 week Yoga therapy class adapted to the specific needs of the veteran. The class meets two times per weeks for 90 minutes. A series of poses are instructed, with adaptations used as provided by a physical therapist.', 'interventionNames': ['Behavioral: Yoga therapy']}, {'type': 'NO_INTERVENTION', 'label': '2. Wait list', 'description': 'The comparative intervention is an 8 week wait list control group for which there is no intervention provided within the study protocol.'}], 'interventions': [{'name': 'Yoga therapy', 'type': 'BEHAVIORAL', 'description': 'For the second aim of the study, individuals will complete an 8 week yoga intervention in a non-randomized trial to establish safe procedures for yoga for an older post colorectal cancer veteran population.', 'armGroupLabels': ['1. Yoga therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Brockton Campus, Brockton, MA', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}], 'overallOfficials': [{'name': 'Jennifer Ann Moye, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System Brockton Campus, Brockton, MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}