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Trial Title:
Evaluation of a Couple-Based Physical Activity Intervention
NCT ID:
NCT06073951
Condition:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Arm II (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Exercise Counseling
Description:
Receive walking step goals
Arm group label:
Arm I (Mates in Motion)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Participate in Mates in Motion program
Arm group label:
Arm I (Mates in Motion)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear Actigraph
Arm group label:
Arm I (Mates in Motion)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear Garmin activity tracker
Arm group label:
Arm I (Mates in Motion)
Arm group label:
Arm II (usual care)
Intervention type:
Other
Intervention name:
Physical Performance Testing
Description:
Undergo walk-test
Arm group label:
Arm I (Mates in Motion)
Arm group label:
Arm II (usual care)
Other name:
Physical Fitness Testing
Other name:
Physical Function Testing
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaires
Arm group label:
Arm I (Mates in Motion)
Arm group label:
Arm II (usual care)
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.
Detailed description:
PRIMARY OBJECTIVES:
I. To determine feasibility of recruitment, adherence, and retention of a couple-based
physical activity (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.
Criteria for eligibility:
Criteria:
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: 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Yahaira Perez Gonzales
Phone:
480-342-0671
Email:
PerezGonzalez.Yahaira@mayo.edu
Investigator:
Last name:
Nandita Khera, M.D., M.P.H.
Email:
Principal Investigator
Start date:
March 11, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073951
https://www.mayo.edu/research/clinical-trials
