Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04716920
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2020-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Patients With Stage I-III Breast Cancer, the TaiChi4Joint Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026302', 'term': 'Tai Ji'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tai Chi practice', 'timeFrame': 'Up to 12 weeks', 'description': 'Diary log form.'}, {'measure': 'Tai Chi practice', 'timeFrame': 'Up to 12 weeks', 'description': 'Examples include documenting potential issues that participants think might be intervention-related.'}, {'measure': "Assess the client's perspective on the value of services received", 'timeFrame': 'Up to 36 weeks', 'description': 'Will be assessed using the Client Satisfaction Questionnaire. Qualitatively, five questions, adapted from previous yoga research will be used in post-intervention patient interview.'}, {'measure': 'Lower-extremity joint symptoms', 'timeFrame': 'Up to 12 weeks', 'description': 'Western Ontario and McMaster Universities Arthritis Index will be used to assess pain in the past 7 days in three domains: pain, stiffness, and physical function; higher scores indicating worse pain, stiffness, and functional limitations.'}, {'measure': 'Pain, stiffness, and physical function in the hands', 'timeFrame': 'Up to 12 weeks', 'description': 'Australian/Canadian Osteoarthritis (OA) Hand Index will be used to assess pain, stiffness, and physical function in the hands.'}, {'measure': 'Assess pain, pain severity, and pain interference', 'timeFrame': 'up to 12 weeks', 'description': 'Brief Pain Inventory will be used to assess worst pain, pain severity, and pain interference over the past week.'}, {'measure': 'Fatigue', 'timeFrame': 'Up to 12 weeks', 'description': 'Fatigue Symptom Inventory will be used to measure change in fatigue among breast cancer (BCa) patients and with strong internal consistency.'}, {'measure': 'Effects of Hot Flashes on Quality of life', 'timeFrame': 'Up to 12 weeks', 'description': 'Hot Flash Related Daily Interference Scale will be used to measure the effect of hot flashes on overall quality of life and on nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, and enjoyment of life.'}, {'measure': 'Assessment of Sleep quality', 'timeFrame': 'Up to 12 weeks', 'description': 'Pittsburg Sleep Quality Index will be used to for subjective sleep assessment, which includes multiple sleep-related variables over the preceding month.'}, {'measure': 'Cancer-related distress', 'timeFrame': 'Up to 12 weeks', 'description': 'Centers for Epidemiologic Studies Depression Scale will be used to assess depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomic Stage I Breast Cancer AJCC v8', 'Anatomic Stage IA Breast Cancer AJCC v8', 'Anatomic Stage IB Breast Cancer AJCC v8', 'Anatomic Stage II Breast Cancer AJCC v8', 'Anatomic Stage IIA Breast Cancer AJCC v8', 'Anatomic Stage IIB Breast Cancer AJCC v8', 'Anatomic Stage III Breast Cancer AJCC v8', 'Anatomic Stage IIIA Breast Cancer AJCC v8', 'Anatomic Stage IIIB Breast Cancer AJCC v8', 'Anatomic Stage IIIC Breast Cancer AJCC v8', 'Prognostic Stage I Breast Cancer AJCC v8', 'Prognostic Stage IA Breast Cancer AJCC v8', 'Prognostic Stage IB Breast Cancer AJCC v8', 'Prognostic Stage II Breast Cancer AJCC v8', 'Prognostic Stage IIA Breast Cancer AJCC v8', 'Prognostic Stage IIB Breast Cancer AJCC v8', 'Prognostic Stage III Breast Cancer AJCC v8', 'Prognostic Stage IIIA Breast Cancer AJCC v8', 'Prognostic Stage IIIB Breast Cancer AJCC v8', 'Prognostic Stage IIIC Breast Cancer AJCC v8']}, 'referencesModule': {'references': [{'pmid': '35727609', 'type': 'DERIVED', 'citation': 'Gomaa S, West C, Lopez AM, Zhan T, Schnoll M, Abu-Khalaf M, Newberg A, Wen KY. A Telehealth-Delivered Tai Chi Intervention (TaiChi4Joint) for Managing Aromatase Inhibitor-Induced Arthralgia in Patients With Breast Cancer During COVID-19: Longitudinal Pilot Study. JMIR Form Res. 2022 Jun 21;6(6):e34995. doi: 10.2196/34995.'}]}, 'descriptionModule': {'briefSummary': 'This trial studies new methods using Tai Chi for the relief of joint pain (arthralgia) caused by an aromatase inhibitor in patients with stage I-III breast cancer. Tai Chi is a mind-body therapy that integrates moderate physical activity, deep breathing and meditation. Tai Chi may help to reduce aromatase inhibitor-induced joint pain, and offer a promising approach to managing symptoms in cancer patients.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week Tai Chi intervention for relieving aromatase inhibitor (AI)-induced arthralgia in women with breast cancer (BCa).\n\nOUTLINE:\n\nPatients attend Tai Chi exercise classes over 1 hour twice weekly (BIW) and wear a Fitbit device for up to 12 weeks. Patients are encouraged to complete self-practice over 30 minutes and record practice times daily in a diary log form. Patients also join a Facebook private TaiChi4joint group where they receive instructional videos matching the progress of weekly classes for at-home practices and peer support in Tai Chi engagement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be able to speak and read English\n* Been diagnosed with stage I-III breast cancer (BC)\n* Had completed all active treatments\n* Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months\n* Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI\n* Report worst pain in the past week \\>= 4 on a 0-10 numeric rating scale\n* Be willing to adhere to all study procedures\n\nExclusion Criteria:\n\n* Has been diagnosed with another form of cancer in the past 5 years\n* Uncontrolled cardiac, pulmonary, or infectious disease\n* Body mass index (BMI) \\> 40 kg/m\\^2\n* Currently attending any mind-body therapy classes (e.g. yoga)\n* Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record \\[EMR\\] data)\n* Had surgery or joint infection in the past 6 months\n* Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months'}, 'identificationModule': {'nctId': 'NCT04716920', 'briefTitle': 'Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Patients With Stage I-III Breast Cancer, the TaiChi4Joint Trial', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '20G.093'}, 'secondaryIdInfos': [{'id': 'NCI-2020-02555', 'type': 'OTHER', 'domain': 'The Buck Foundation'}, {'id': 'JT 14910', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)', 'description': 'Patients attend Tai Chi exercise classes over 1 hour BIW and wear a Fitbit device for up to 12 weeks. Patients are encouraged to complete self-practice over 30 minutes and record practice times daily in a diary log form. Patients also join a Facebook private TaiChi4joint group where they receive instructional videos matching the progress of weekly classes for at-home practices and peer support in Tai Chi engagement.', 'interventionNames': ['Other: Tai Chi', 'Device: FitBit', 'Other: Support Group Therapy', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Tai Chi', 'type': 'OTHER', 'description': 'Attend Tai Chi exercise classes', 'armGroupLabels': ['Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)']}, {'name': 'FitBit', 'type': 'DEVICE', 'description': 'Wear FitBit', 'armGroupLabels': ['Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)']}, {'name': 'Support Group Therapy', 'type': 'OTHER', 'description': 'Join Tai4Chijoint group', 'armGroupLabels': ['Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (Tai Chi, Fitbit, Tai4Chijoint group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}