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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a program called Mates in Motion, a couple-based physical activity intervention, can increase activity levels in blood cancer patients and their partners. It targets those undergoing treatments like stem cell transplants or CAR-T cell therapy, focusing on improving communication and setting goals to enhance physical activity. Participants will either join the Mates in Motion program or receive usual care, with an activity tracker provided at the end. It suits patients in a committed relationship, approved by their doctor for a walking program, and about to begin specific cancer treatments. As an unphased trial, this study offers a unique opportunity to explore innovative ways to enhance well-being during treatment.

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 prior data suggests that this couple-based physical activity intervention is safe for blood cancer patients and their caregivers?

Research has shown that physical activity programs, such as Mates in Motion, are safe for individuals during and after cancer treatment. Participants in similar programs with their partners found them easy and helpful. Studies have found that exercise benefits cancer patients, even those undergoing treatments like hematopoietic cell transplantation (HCT). No major reports of negative effects from these programs have emerged. Participants often find the program useful for improving physical health and activity levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Mates in Motion" program because it offers a unique approach to supporting blood cancer patients through physical activity. Unlike traditional treatments which focus primarily on medical interventions, this program emphasizes communal coping by engaging patients and their partners in a collaborative effort to achieve physical activity goals. The program includes skill-building in effective communication, adaptive speaking, and responsive listening, which can strengthen relationships and potentially improve adherence to physical activity routines. This holistic approach not only targets physical health but also enhances emotional and social well-being, making it an innovative addition to current care strategies.

What evidence suggests that the Mates in Motion intervention is effective for improving physical activity in blood cancer patients?

Research has shown that couple-based exercise programs like Mates in Motion, which participants in this trial may receive, can help people become more active. Studies have found that these programs lead to more weekly steps and increased levels of moderate to vigorous exercise. Participants in these studies reported losing weight and lowering their body mass index (BMI). Additionally, these programs can help reduce pain and improve overall physical health. This suggests that Mates in Motion could effectively boost physical endurance and health for blood cancer patients and their partners. ^{1 2 3 4 6}

Who Is on the Research Team?

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

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-neoplasms-8-2023-daa8b

Couple-Based Physical Activity Intervention for Blood Cancer ... This clinical trial tests how well a couple-based physical activity (PA) intervention, Mates in Motion, works in patients undergoing hematopoietic cell ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06073951

Evaluation 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10877394/

Physical Activity Intervention Characteristics and Effects on ... These improved outcomes included increased weekly steps, decreased BMI and body weight, increased moderate-to-vigorous intensity PA (MVPA)/week, reduced pain ...

4. astctjournal.org astctjournal.org/article/S2666-6367(24)00160-X/pdf

Feasibility and Acceptability of a Couple-Based Physical ... Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors. Health. Psychology ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03266718

Move 2 Health: A Couple-Based Physical Activity ... This pilot study will develop and test a couple-based physical activity intervention among cancer survivors and their partners.

6. astctjournal.org astctjournal.org/article/S2666-6367(24)00160-X/fulltext

Feasibility and Acceptability of a Couple-Based Physical ... A couple-based physical activity intervention for hematopoietic cell transplant recipients and their caregiving partners was deemed feasible and acceptable.