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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-07197 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-008130 | Other Identifier | Mayo Clinic in Arizona | |
| R21CA275085-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. To determine feasibility of recruitment, adherence, and retention of a couple-based PA intervention in a pilot randomized controlled trial (RCT).
II. Determine acceptability of the intervention (multiple dimensions of treatment satisfaction).
III. Describe changes in PA, physical endurance, and global physical health from baseline to follow-up as a function of randomized condition.
OUTLINE: Patient-caregiver dyads are randomized to 1 of 2 arms.
ARM 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.
ARM 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Mates in Motion) | Experimental | 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. |
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| Arm II (usual care) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed recruitment | Will be assessed by the percentage of eligible patient-partner couples agreeing to participate | At baseline |
| Intervention adherence | Will be assessed by the number of intervention sessions attended. | 8 weeks |
| Actigraph wear adherence | Will be assessed by the number of valid wear days. | 8 weeks |
| Garmin wear adherence | Will be assessed by the number of valid wear days. | 8 weeks |
| Retention | Will be assessed by the number of post-intervention follow-up assessments completed. | At 100 days post-hematopoietic cell transplant (HCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the intervention | 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. | At 100 days post-hematopoietic cell transplant (HCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nandita Khera, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2025 | Sep 2, 2025 |
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| Exercise Counseling | Other | Receive walking step goals |
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| Exercise Intervention | Other | Participate in Mates in Motion program |
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| Medical Device Usage and Evaluation | Other | Wear Actigraph |
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| Medical Device Usage and Evaluation | Other | Wear Garmin activity tracker |
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| Physical Performance Testing | Other | Undergo walk-test |
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| Questionnaire Administration | Other | Complete questionnaires |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
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