Couple-Based Physical Activity Intervention for Blood Cancer Patients

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Non-partnered, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Mates in Motion, Couple-Based Physical Activity Intervention for blood cancer patients?

Research shows that exercise can improve physical fitness, reduce fatigue, and enhance quality of life for cancer patients, including those with blood cancers. These benefits suggest that a couple-based physical activity program like Mates in Motion could be effective in supporting blood cancer patients. ^{1 2 3 4 5}

Is the Couple-Based Physical Activity Intervention safe for blood cancer patients?

Exercise interventions, including those for cancer patients, are generally considered safe and have health benefits, but specific safety data for blood cancer patients undergoing chemotherapy is limited and under-investigated. ^{6 7 8 9 10}

How is the Couple-Based Physical Activity Intervention different from other treatments for blood cancer patients?

The Couple-Based Physical Activity Intervention is unique because it involves both the cancer survivor and their romantic partner in a joint exercise program, which can improve exercise adherence and outcomes by leveraging the support and motivation from the partner. ^{2 6 7 10 11}

Research Team

Nandita Khera, M.D., M.P.H.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for English-speaking adults over 18 who are about to receive a bone marrow transplant and have a committed partner. Both the patient and caregiver must be approved by a doctor to participate in a walking program.

Inclusion Criteria

I am scheduled for a stem cell transplant using my own or a donor's cells.

I can join a walking program.

PATIENTS: Physician-approved for a walking program

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Dyads participate in the Mates in Motion program with weekly sessions focusing on communal coping strategies and communication skills over 8 weeks

8 weeks

8 weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for retention and intervention adherence, including assessments at 100 days post-HCT

100 days post-HCT

Treatment Details

Interventions

• Mates in Motion

Trial Overview The 'Mates in Motion' intervention is being tested, which includes exercise counseling, physical performance tests, medical device usage, questionnaires, and best practice training for couples where one is undergoing hematopoietic cell transplantation.

Participant Groups

Group I: Arm I (Mates in Motion) Experimental Treatment 5 Interventions

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.

Group II: Arm II (usual care) Active Control 4 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A systematic review of 15 studies found that exercise interventions significantly improved physical fitness in adults with hematological malignancies, as measured by the 6-minute walk test and peak oxygen consumption.

While exercise did not show significant effects on grip strength, fatigue, or overall quality of life when comparing groups, within-group analysis indicated that combination exercise improved quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions for physical fitness, fatigue, and quality of life in adult hematologic malignancy patients without receiving hematopoietic stem cell transplantation: a systematic review and meta-analysis. Xu, W., Yang, L., Wang, Y., et al.[2022]

A systematic review of 56 trials involving 4,826 participants found that exercise interventions significantly improved overall health-related quality of life (HRQOL) and specific domains such as physical and social functioning in adults undergoing cancer treatment.

Moderate-to-vigorous intensity exercise was particularly effective in enhancing HRQOL, suggesting that incorporating such exercise programs into cancer care could be beneficial for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise interventions for improving health-related quality of life from diagnosis through active cancer treatment. Mishra, SI., Scherer, RW., Snyder, C., et al.[2022]

A systematic review of 8 studies found that exercise interventions significantly improve cardiorespiratory fitness and lower extremity muscle strength in patients with hematologic malignancies undergoing stem cell transplantation, with effect sizes of 0.53 and 0.56, respectively.

Exercise also helps reduce fatigue and positively impacts overall quality of life, although all studies had some risk of bias, indicating a need for further high-quality research to confirm these benefits and optimize exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise in patients treated with stem cell transplantation for a hematologic malignancy: a systematic review and meta-analysis. Persoon, S., Kersten, MJ., van der Weiden, K., et al.[2022]

Exercise interventions have strong positive effects on the physical and psychological well-being of cancer patients, improving physical function, muscle strength, emotional health, and reducing fatigue, anxiety, and depression.

Nurses are encouraged to incorporate tailored exercise recommendations into cancer care to enhance patients' physical functioning and psychological health, although more research is needed on the impact of exercise on spiritual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and quality of life outcomes in patients with cancer. Knobf, MT., Musanti, R., Dorward, J.[2007]

Patients with cancer undergoing chemotherapy reported that participating in exercise interventions provided temporary relief from the overwhelming side effects of treatment, suggesting a potential benefit for their well-being.

The qualitative meta-synthesis, which included insights from 193 patients across various demographics, highlighted the complex emotional and existential experiences of patients, indicating that exercise may help them cope with the psychological burdens of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative exploration of the perceptions of exercise in patients with cancer initiated during chemotherapy: a meta-synthesis. Andersen, C., Adamsen, L., Damhus, CS., et al.[2023]

A pilot trial involving 20 cancer survivors and their partners tested a couple-based physical activity intervention, showing that it was generally acceptable and feasible, with 78% of participants completing all sessions.

Participants in the intervention reported greater improvements in physical activity, partner support, and physical well-being compared to those in the control group, suggesting potential benefits for future larger-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors. Porter, LS., Gao, X., Lyna, P., et al.[2023]

A significant majority of cancer survivors (51.8%) and their partners (61.5%) believe that couples-based exercise is important and express interest in participating in such programs, indicating a strong potential for joint exercise initiatives.

Partner support for exercise is a key factor influencing both survivors' and partners' beliefs about couples-based exercise, suggesting that including partners in exercise programs could enhance the effectiveness of physical activity for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beliefs and interests in physical activity programs of cancer survivors and their romantic partners. Ulrich, GR., Callan, S., Ranby, KW.[2023]

A feasibility study involving 14 young adults (ages 20-34) undergoing chemotherapy showed that they are willing to participate in physical activity research, indicating potential for future studies.

Participants reported significant variability in their physical activity levels and experienced high levels of fatigue, suggesting a need for interventions to enhance physical activity during cancer treatment to help manage symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study to Measure Physical Activity, Fatigue, Sleep-Wake Disturbances, and Depression in Young Adults During Chemotherapy. Erickson, JM., Adelstein, KE., Letzkus, LC.[2021]

Exercise interventions during and after chemotherapy for patients with hematological cancer are generally reported as safe and feasible, based on a systematic review of 12 studies, including six randomized controlled trials.

Despite the positive claims about safety and feasibility, many studies lack detailed information on how these conclusions were reached, highlighting the need for more comprehensive reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. Großek, A., Großek, K., Bloch, W.[2023]

A remotely-delivered exercise education video significantly improved exercise knowledge and beliefs among cancer survivors and their partners, with participants in the education group more accurately reporting the recommended physical activity guidelines.

The intervention particularly enhanced survivors' perceptions of the importance of exercise and their likelihood of participating in individual exercise programs, suggesting that targeted education can motivate cancer couples to engage in physical activity together.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of remotely-delivered physical activity education on exercise beliefs and intentions of active and nonactive cancer survivors and their partners. Ulrich, GR., Nogg, KA., Freeman, SZ., et al.[2022]

Only 21% of the studies reviewed showed that participants maintained significantly higher levels of physical activity at least 6 months after completing an exercise intervention, indicating that long-term maintenance of activity is a challenge for cancer survivors.

Key behavior change techniques such as social support, goal setting, and action planning, along with supervised exercise, were identified as important for helping maintain physical activity, but more research is needed to confirm their effectiveness in ensuring lasting health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity behaviour change in people living with and beyond cancer following an exercise intervention: a systematic review. Salisbury, CE., Hyde, MK., Cooper, ET., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions for physical fitness, fatigue, and quality of life in adult hematologic malignancy patients without receiving hematopoietic stem cell transplantation: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise interventions for improving health-related quality of life from diagnosis through active cancer treatment. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of exercise in patients treated with stem cell transplantation for a hematologic malignancy: a systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise and quality of life outcomes in patients with cancer. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Qualitative exploration of the perceptions of exercise in patients with cancer initiated during chemotherapy: a meta-synthesis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Beliefs and interests in physical activity programs of cancer survivors and their romantic partners. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Feasibility Study to Measure Physical Activity, Fatigue, Sleep-Wake Disturbances, and Depression in Young Adults During Chemotherapy. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effects of remotely-delivered physical activity education on exercise beliefs and intentions of active and nonactive cancer survivors and their partners. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Physical activity behaviour change in people living with and beyond cancer following an exercise intervention: a systematic review. [2023]