Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 4:49 AM
Study NCT ID:
NCT05205512
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2021-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to the telehealth exercise intervention', 'timeFrame': 'Up to 2 years', 'description': 'Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).'}], 'secondaryOutcomes': [{'measure': 'Effects of an 8-week telehealth exercise intervention', 'timeFrame': 'At baseline up to week 9', 'description': 'The physiologic effects of telehealth exercise intervention will be assessed by peak oxygen consumption (VO2) using cardiopulmonary exercise testing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hodgkin Lymphoma', 'Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This clinical trial tests how well a telehealth exercise intervention works to improve cardiovascular health in lymphoma survivors. Telehealth exercise is a service to help perform physical exercises at home with a care provider online. With the use of telehealth exercise lymphoma survivors may be able to participate in exercise programs safely to improve heart health and reduce the risk of cardiovascular disease.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention.\n\nSECONDARY OBJECTIVE:\n\nI. Explore the effects of an 8-week telehealth exercise intervention on cardiovascular health, assessed by cardiopulmonary exercise test, pulmonary function test, body compositions, and blood biomarkers.\n\nOUTLINE: Participants are randomized into 1 of 2 groups.\n\nGROUP I (TELEHEALTH EXERCISE): Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.\n\nGROUP II (DELAYED CONTROL): Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.\n\nAfter completion of study treatment, participants are followed up after 1 week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Hodgkin or non-Hodgkin lymphoma.\n* \\>= 18 years old.\n* Are between 2-5 years after completing anti-cancer therapy and with no evidence of disease.\n* Intermediate (4-5) to high ( \\>= 6) risk of cardiovascular risk factors based on six key variables: Age 30 to 50 years (y) \\[2\\]) and \\>= 50y \\[3\\]; anthracycline dose \\>250mg/m \\^ 2 \\[1\\]; hypertension \\[2\\]; diabetes \\[2\\]; smoking \\[1\\]; and chest radiation \\[1\\]).\n* Able to understand and sign the informed consent document.\n* Physically able and willing to complete all study procedures.\n\nExclusion Criteria:\n\n* Have overt cardiovascular disease within 6 months (e.g. myocardial infarction, stroke, angina).\n* Have contraindications to exercise.\n* Participate in structured exercise (\\>60 minutes/week).\n* Female patients who are pregnant or planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT05205512', 'briefTitle': 'Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors (TECHS): A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': '21595'}, 'secondaryIdInfos': [{'id': 'NCI-2021-13305', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '21595', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (telehealth exercise)', 'description': 'Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.', 'interventionNames': ['Other: Questionnaire Administration', 'Other: Telemedicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (delayed control)', 'description': 'Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.', 'interventionNames': ['Other: Exercise Intervention', 'Other: Questionnaire Administration', 'Other: Telemedicine']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'OTHER', 'description': 'Maintain current levels of physical activity', 'armGroupLabels': ['Group II (delayed control)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (telehealth exercise)', 'Group II (delayed control)']}, {'name': 'Telemedicine', 'type': 'OTHER', 'otherNames': ['Telehealth'], 'description': 'Participate in telehealth exercise intervention', 'armGroupLabels': ['Group I (telehealth exercise)', 'Group II (delayed control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Kyuwan Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}