Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT07186556
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Adverse Events (AEs)', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Fatigue', 'Brain Tumor Adult']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.', 'detailedDescription': 'Primary Objective:\n\nTest the efficacy of RISE-YA to improve CRF\n\nSecondary Objectives:\n\n1. Test the efficacy of RISE-YA to improve PA and physical function in fatigued YA brain tumor survivors.\n2. Determine A) cross-sectional associations of CRF with oxidative phosphorylation (OxPhos) and with inflammation, and B) the effect of RISE-YA on OxPhos and on inflammation.\n\nExploratory Objective:\n\nAssess the effect of our supervised exercise intervention on patient-reported health-related quality of life, muscle mass development (BMI, skinfold and circumferences \\[waist, arm, and calf area\\]), patient-reported dietary intake, and exercise adherence and progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Is currently between the ages of 18-39 years\n2. Their primary brain tumor was diagnosed at age 15-39 years\n3. Is 6 months to \\<5 years post curative treatment\n4. Has been treated with chemotherapy and radiation, given most patients receive both therapies.\n5. Functional Assessment of Chronic Illness therapy (FACIT)-Fatigue ≤ 43. FACIT-Fatigue will be used as a screener because this 13-item scale can be completed relatively quickly in clinic\n6. Currently engage in \\<150 minutes of PA and \\< 2 sessions of muscle strengthening exercise per week (assessed by Godin Leisure-Time PA Questionnaire)\n7. Must be able to speak, write, and read English\n8. No exercise contraindication as assessed by screening with the Physical Activity Readiness Questionnaire PAR-Q+. In addition, participants' care teams will be notified of their participation in the study.\n9. Must be able to provide informed consent/assent.\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. Screen failure for exercise safety\n3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease\n4. Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions\n5. History of underlying chronic disease, secondary malignances, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain\n6. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.\n7. Self-report of pregnancy\n8. Prisoners\n9. Documented developmental disorders (e.g., Autism) or major psychotic illness (e.g., schizophrenia)"}, 'identificationModule': {'nctId': 'NCT07186556', 'briefTitle': 'Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Cancer-related Fatigue and Its Biological Contributors in Adolescent and Young Adult Brain Tumor Survivors: Effects of a Tele-exercise Intervention', 'orgStudyIdInfo': {'id': '2025-1036'}, 'secondaryIdInfos': [{'id': 'NCI-2025-06748', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attention Control Group', 'description': 'Participants will randomized using incorrect baseline information.', 'interventionNames': ['Behavioral: RISE-YA Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'InItervention Group: Remote Implementation of Supervised Exercise for Young Adult', 'description': 'Participants will randomized using incorrect baseline information.', 'interventionNames': ['Behavioral: Survivorship Education']}], 'interventions': [{'name': 'RISE-YA Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive energy conservation (EC) counseling, behavior coaching, and exercise training.', 'armGroupLabels': ['Attention Control Group']}, {'name': 'Survivorship Education', 'type': 'BEHAVIORAL', 'description': 'During weeks 1-6 and 1 time a week during Weeks 7-12, participants will receive a video call which will last about 60 minutes.', 'armGroupLabels': ['InItervention Group: Remote Implementation of Supervised Exercise for Young Adult']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Roth, MD', 'role': 'CONTACT', 'email': 'mroth1@mdanderson.org', 'phone': '713-792-7751'}, {'name': 'Michael Roth, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas M. D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Michael Roth, MD', 'role': 'CONTACT', 'email': 'mroth1@mdanderson.org', 'phone': '(713) 792-7751'}], 'overallOfficials': [{'name': 'Michael Roth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Prevention Research Institute of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}