Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT04301050
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2020-03-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Learning Yoga to eNhance Cancer Survivorship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '9 months', 'description': 'Enrollment rate of \\> 50% of eligible screened participants'}, {'measure': 'Acceptability', 'timeFrame': '8 weeks', 'description': 'Attendance rate: \\>75% of classes, on average'}], 'secondaryOutcomes': [{'measure': 'Change in Health Behaviors', 'timeFrame': '[Baseline, 8 week]', 'description': "Health behaviors are measured with a 10-item scale adapted from investigators' prior research. Items allow for calculation of body mass index (based on self-reported height and weight), determination of the amount of physical activity per week, and indicators of diet quality. Items are based on American Cancer Society and National Comprehensive Cancer Network guidelines for health behaviors in cancer survivors."}, {'measure': 'Change in Interoceptive Awareness', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by a change in the body listening and trusting sub scales of the Multidimensional Assessment of Interoceptive Awareness (Version 2). Scores on this scale range from 0-5, with higher scores indicating greater interoceptive awareness.'}, {'measure': 'Change in Depression', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF (Patient Reported Outcomes Measurement Information System Short Form) v1.0 - Depression 4a'}, {'measure': 'Change in Anxiety', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF v1.0 - Anxiety 4a'}, {'measure': 'Change in Sleep Disturbance', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF v1.0 - Sleep Disturbance 4a'}, {'measure': 'Change in Fatigue', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF v1.0 - Fatigue 7a'}, {'measure': 'Change in Pain Intensity', 'timeFrame': '[Baseline, 9 week]', 'description': 'As measured by PROMIS Scale v1.0 - Pain Intensity 3a PROMIS SF v1.0 - Fatigue 7a'}, {'measure': 'Change in Pain Interference', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF v1.0 - Pain Interference 6b'}, {'measure': 'Change in Physical Function', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF v2.0 - Physical Function 4a PROMIS SF v2.0 - Physical Function 4a'}, {'measure': 'Change in Positive Affect', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF v1.0 - Positive Affect 15a PROMIS SF v1.0 - Positive Affect 15a'}, {'measure': 'Change in Social Isolation', 'timeFrame': '[Baseline, 8 week]', 'description': 'As measured by PROMIS SF v2.0 - Social Isolation 8a'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young Adult', 'Cancer Survivor'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to conduct a single-arm pilot test of online yoga classes for young adult cancer survivors (YACS). Study hypotheses are that LYNC will be feasible (enrollment of \\> 50% of eligible) and acceptable (75% attendance at all sessions). In addition, analyses of preliminary efficacy outcomes will examine whether participants report potential improvements in psychosocial and physical wellbeing.', 'detailedDescription': 'This study will recruit YACS (n=30) for an 8-week course (75-minute yoga classes delivered once per week) delivered online via videoconferencing software such as Zoom or Bluejeans. During yoga classes, all participants will be able to see one another, to simulate the group experience of being in an in-person class. Participants will complete patient-reported outcomes of physical and psychosocial wellbeing at baseline (prior to class 1) and post-intervention (after class 8), as well as post-intervention measures of feasibility/acceptability (e.g., ease of accessing online classes, satisfaction with yoga classes, helpfulness of online yoga, barriers/dislikes associated with online yoga). All surveys will be administered via REDCap. In addition, the investigators will compute rates of retention (% of consenting subjects who complete post-intervention assessment) and adherence (# of yoga classes attended).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 25-39\n* History of cancer diagnosed at age \\>18\n* \\>2 months post-treatment for cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status (0-2)\n* Access to internet-connected device with camera and capacity for full-screen display (e.g., laptop or desktop computer; tablet or smart phone with Air Play to full-size monitor)\n\nExclusion Criteria:\n\n* Regular use of yoga (i.e., once or more per week) since cancer diagnosis/treatment\n* Unable to complete forms and yoga classes in English\n* Adults who are cognitively impaired, pregnant, imprisoned or otherwise detained'}, 'identificationModule': {'nctId': 'NCT04301050', 'acronym': 'LYNC', 'briefTitle': 'Learning Yoga to eNhance Cancer Survivorship', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Learning Yoga to eNhance Cancer Survivorship', 'orgStudyIdInfo': {'id': 'STU00209987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga Intervention', 'description': 'Participants will complete 8-week course (75-minute, weekly yoga classes) delivered online via videoconferencing software. Participants will complete patient-reported outcomes at baseline (prior to class 1) and post-intervention (after class 8), as well as post-intervention measures of feasibility/acceptability.', 'interventionNames': ['Other: Yoga Intervention']}], 'interventions': [{'name': 'Yoga Intervention', 'type': 'OTHER', 'otherNames': ['Yoga'], 'description': 'Weekly 75-minute yoga classes.', 'armGroupLabels': ['Yoga Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Elizabeth Addington, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elizabeth Addington', 'investigatorAffiliation': 'Northwestern University'}}}}