Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06073951
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2023-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Couple-Based Physical Activity Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-22', 'size': 675142, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-02T19:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed recruitment', 'timeFrame': 'At baseline', 'description': 'Will be assessed by the percentage of eligible patient-partner couples agreeing to participate'}, {'measure': 'Intervention adherence', 'timeFrame': '8 weeks', 'description': 'Will be assessed by the number of intervention sessions attended.'}, {'measure': 'Actigraph wear adherence', 'timeFrame': '8 weeks', 'description': 'Will be assessed by the number of valid wear days.'}, {'measure': 'Garmin wear adherence', 'timeFrame': '8 weeks', 'description': 'Will be assessed by the number of valid wear days.'}, {'measure': 'Retention', 'timeFrame': 'At 100 days post-hematopoietic cell transplant (HCT)', 'description': 'Will be assessed by the number of post-intervention follow-up assessments completed.'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the intervention', 'timeFrame': 'At 100 days post-hematopoietic cell transplant (HCT)', 'description': 'Will be assessed among patients and caregivers and will examine ratings for the following treatment satisfaction domains relative to the scale midpoint: suitability, utility, attitude toward treatment, desire for continued treatment use, therapist competence, therapist interpersonal style, format and dose, and perceived benefits.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid System Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial tests how well a couple-based physical activity (PA) intervention, Mates in Motion, works in patients undergoing hematopoietic cell transplantation (HCT) or chimeric antigen receptor T-cell therapy (CART) and their care giving partners to be more physically active. Mates in Motion provides training in communication skills and behavior change techniques to help HCT patient-caregiver dyads support one another in adoption and maintenance of PA. This study may help researchers determine if a couple-based PA intervention improves PA, physical endurance and global physical health among patient-care giver dyads undergoing HCT or CART.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine feasibility of recruitment, adherence, and retention of a couple-based PA intervention in a pilot randomized controlled trial (RCT).\n\nII. Determine acceptability of the intervention (multiple dimensions of treatment satisfaction).\n\nIII. Describe changes in PA, physical endurance, and global physical health from baseline to follow-up as a function of randomized condition.\n\nOUTLINE: Patient-caregiver dyads are randomized to 1 of 2 arms.\n\nARM I: Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.\n\nARM II: Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENTS: Age 18 years or older\n* PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)-T cell therapy\n* PATIENTS: Able to speak and comprehend English\n* PATIENTS: Being married or in a committed (self-defined) cohabiting same- or opposite-sex relationship\n* PATIENTS: Physician-approved for a walking program\n* CAREGIVERS: Age 18 years or older\n* CAREGIVERS: Able to speak and comprehend English\n* CAREGIVERS: Married to or in a committed, cohabiting, same- or opposite-sex relationship with the patient\n* CAREGIVERS: Able to participate in a walking program\n\nExclusion Criteria:\n\n* None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered'}, 'identificationModule': {'nctId': 'NCT06073951', 'briefTitle': 'Evaluation of a Couple-Based Physical Activity Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Mates in Motion: Feasibility and Acceptability of a Couple-Based Physical Activity Intervention', 'orgStudyIdInfo': {'id': '23-008130'}, 'secondaryIdInfos': [{'id': 'NCI-2023-07197', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '23-008130', 'type': 'OTHER', 'domain': 'Mayo Clinic in Arizona'}, {'id': 'R21CA275085-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21CA275085-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (Mates in Motion)', 'description': 'Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.', 'interventionNames': ['Other: Exercise Counseling', 'Other: Exercise Intervention', 'Other: Medical Device Usage and Evaluation', 'Other: Physical Performance Testing', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (usual care)', 'description': 'Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.', 'interventionNames': ['Other: Best Practice', 'Other: Medical Device Usage and Evaluation', 'Other: Physical Performance Testing', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive usual care', 'armGroupLabels': ['Arm II (usual care)']}, {'name': 'Exercise Counseling', 'type': 'OTHER', 'description': 'Receive walking step goals', 'armGroupLabels': ['Arm I (Mates in Motion)']}, {'name': 'Exercise Intervention', 'type': 'OTHER', 'description': 'Participate in Mates in Motion program', 'armGroupLabels': ['Arm I (Mates in Motion)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Wear Actigraph', 'armGroupLabels': ['Arm I (Mates in Motion)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Wear Garmin activity tracker', 'armGroupLabels': ['Arm I (Mates in Motion)', 'Arm II (usual care)']}, {'name': 'Physical Performance Testing', 'type': 'OTHER', 'otherNames': ['Physical Fitness Testing', 'Physical Function Testing'], 'description': 'Undergo walk-test', 'armGroupLabels': ['Arm I (Mates in Motion)', 'Arm II (usual care)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Arm I (Mates in Motion)', 'Arm II (usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Nandita Khera, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}