Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBest Practice
Receive usual care
OTHERExercise Counseling
Receive walking step goals
OTHERExercise Intervention
Participate in Mates in Motion program
OTHERMedical Device Usage and Evaluation
Wear Actigraph
OTHERPhysical Performance Testing
Undergo walk-test
OTHERQuestionnaire Administration
Complete questionnaires
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* PATIENTS: Age 18 years or older * PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)-T cell therapy * PATIENTS: Able to speak and comprehend English * PATIENTS: Being married or in a committed (self-defined) cohabiting same- or opposite-sex relationship * PATIENTS: Physician-approved for a walking program * CAREGIVERS: Age 18 years or older * CAREGIVERS: Able to speak and comprehend English * CAREGIVERS: Married to or in a committed, cohabiting, same- or opposite-sex relationship with the patient * CAREGIVERS: Able to participate in a walking program
Exclusion criteria
* None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed recruitment | At baseline | Will be assessed by the percentage of eligible patient-partner couples agreeing to participate |
| Intervention adherence | 8 weeks | Will be assessed by the number of intervention sessions attended. |
| Actigraph wear adherence | 8 weeks | Will be assessed by the number of valid wear days. |
| Garmin wear adherence | 8 weeks | Will be assessed by the number of valid wear days. |
| Retention | At 100 days post-hematopoietic cell transplant (HCT) | Will be assessed by the number of post-intervention follow-up assessments completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the intervention | At 100 days post-hematopoietic cell transplant (HCT) | 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. |
Countries
United States
Outcome results
None listed