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Evaluation of a Couple-Based Physical Activity Intervention

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06073951
Collaborator
National Cancer Institute (NCI) (NIH)
100
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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) 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Exercise Counseling
  • Other: Exercise Intervention
  • Other: Medical Device Usage and Evaluation
  • Other: Medical Device Usage and Evaluation
  • Other: Physical Performance Testing
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. To determine feasibility of recruitment, adherence, and retention of a couple-based physical activity (PA) intervention in a pilot randomized controlled trial (RCT).

  2. Determine acceptability of the intervention (multiple dimensions of treatment satisfaction).

  3. 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: Patient-partner 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 emphasis 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 Fitbit 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 Fitbit at the end of the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Mates in Motion: Feasibility and Acceptability of a Couple-Based Physical Activity Intervention
Anticipated Study Start Date :
Nov 30, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (Mates in Motion)

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 Fitbit on study.

Other: Exercise Counseling
Receive walking step goals

Other: Exercise Intervention
Participate in Mates in Motion program

Other: Medical Device Usage and Evaluation
Wear Actigraph

Other: Medical Device Usage and Evaluation
Wear Fitbit

Other: Physical Performance Testing
Undergo walk-test
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

    • Other: Questionnaire Administration
    Complete questionnaires
    Active Comparator: Arm II (usual care)

    Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Fitbit at the end of the study.

    Other: Best Practice
    Receive usual care
    Other Names:
  • standard of care
  • standard therapy

    • Other: Medical Device Usage and Evaluation
    Wear Fitbit

    Other: Physical Performance Testing
    Undergo walk-test
    Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

    • Other: Questionnaire Administration
    Complete questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Observed recruitment [At baseline]

      Will be assessed by the percentage of eligible patient-partner couples agreeing to participate

    2. Intervention adherence [8 weeks]

      Will be assessed by the number of intervention sessions attended.

    3. Actigraph wear adherence [8 weeks]

      Will be assessed by the number of valid wear days.

    4. Fitbit wear adherence [8 weeks]

      Will be assessed by the number of valid wear days.

    5. Retention [At 100 days post-hematopoietic cell transplant (HCT)]

      Will be assessed by the number of post-intervention follow-up assessments completed.

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • PATIENTS: Age 18 years or older

    • PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT)

    • 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: 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Nandita Khera, M.D., M.P.H., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT06073951
    Other Study ID Numbers:
    • 23-008130
    • NCI-2023-07197
    • 23-008130
    • P30CA015083
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 13, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Oct 13, 2023