Hematopoietic and Lymphoid System NeoplasmNCT06073951
Evaluation of a Couple-Based Physical Activity Intervention
A study testing Best Practice, Exercise Counseling and Exercise Intervention in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Exercise Counseling and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mates in Motion: Feasibility and Acceptability of a Couple-Based Physical Activity Intervention
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Best Practice, Exercise Counseling, Exercise Intervention, Medical Device Usage and Evaluation, Physical Performance Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Exercise CounselingOther
Receive walking step goals
Exercise InterventionOther
Participate in Mates in Motion program
Medical Device Usage and EvaluationOther
Wear Actigraph
Medical Device Usage and EvaluationOther
Wear Garmin activity tracker
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Undergo walk-test
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Counseling; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Questionnaire Administration |
| 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. Receives: Other: Best Practice; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed recruitment
Will be assessed by the percentage of eligible patient-partner couples agreeing to participate
Measured: At baseline
Intervention adherence
Will be assessed by the number of intervention sessions attended.
Measured: 8 weeks
Actigraph wear adherence
Will be assessed by the number of valid wear days.
Measured: 8 weeks
Garmin wear adherence
Will be assessed by the number of valid wear days.
Measured: 8 weeks
Retention
Will be assessed by the number of post-intervention follow-up assessments completed.
Measured: At 100 days post-hematopoietic cell transplant (HCT)
Secondary outcomes (1)
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.
Measured: At 100 days post-hematopoietic cell transplant (HCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Mar 2024
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nandita Khera, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073951
- Sponsor's protocol ID
- 23-008130
- Other IDs
- NCI-2023-07197, 23-008130, R21CA275085-01A1
- Status last verified
- Sep 2025
- First submitted
- 2 Oct 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mates in Motion: Feasibility and Acceptability of a Couple-Based Physical Activity Intervention
- ClinicalTrials.gov ID
- NCT06073951
- Acronym / sponsor ID
- 23-008130
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Mates in Motion) | Experimental | Other: Exercise Counseling, Other: Exercise Intervention, Other: Medical Device Usage and Evaluation, Other: Physical Performance Testing, Other: Questionnaire AdministrationDyads 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 (usual care) | Active comparator | Other: Best Practice, Other: Medical Device Usage and Evaluation, Other: Physical Performance Testing, Other: Questionnaire AdministrationPatient-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm II (usual care) |
| Exercise CounselingReceive walking step goals | Other | Arm I (Mates in Motion) |
| Exercise InterventionParticipate in Mates in Motion program | Other | Arm I (Mates in Motion) |
| Medical Device Usage and EvaluationWear Actigraph | Other | Arm I (Mates in Motion) |
| Medical Device Usage and EvaluationWear Garmin activity tracker | Other | Arm I (Mates in Motion), Arm II (usual care) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingUndergo walk-test | Other | Arm I (Mates in Motion), Arm II (usual care) |
| Questionnaire AdministrationComplete questionnaires | Other | Arm I (Mates in Motion), Arm II (usual care) |
Primary outcome
Observed recruitment
Time frame: At baseline
Will be assessed by the percentage of eligible patient-partner couples agreeing to participate
Intervention adherence
Time frame: 8 weeks
Will be assessed by the number of intervention sessions attended.
Actigraph wear adherence
Time frame: 8 weeks
Will be assessed by the number of valid wear days.
Garmin wear adherence
Time frame: 8 weeks
Will be assessed by the number of valid wear days.
Retention
Time frame: At 100 days post-hematopoietic cell transplant (HCT)
Will be assessed by the number of post-intervention follow-up assessments completed.
1 secondary outcome
Acceptability of the intervention
Time frame: At 100 days post-hematopoietic cell transplant (HCT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandita Khera, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Exercise Counseling and Exercise Intervention in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed recruitment (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.