Couple's Exercise Program for Cancer

Overseen By Carolyn Guidarelli

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Neuromuscular drugs

Disqualifiers: Cognitive difficulties, Poorly controlled diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a partnered exercise program can maintain the physical and mental health of couples when one partner undergoes radiation treatment for cancer. The study will test a program called "Exercising Together," which encourages couples to exercise together, emphasizing communication and support. Participants will be divided into two groups: one will follow the exercise program, while the other will receive educational materials about exercise. The trial seeks couples where one partner has been diagnosed with prostate or breast cancer and is scheduled for radiation therapy, with both partners agreeing to participate. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a medical condition or are taking medications that make moderate exercise unsafe, you may not be eligible to participate.

What prior data suggests that the Exercising Together program is safe for couples during cancer treatment?

Research has shown that exercise programs like Exercising Together are generally safe and manageable for participants. In studies incorporating exercise into cancer treatment, up to 20% of participants may stop within 12 weeks. However, fewer participants tend to drop out when all study groups receive some form of support. This suggests that guidance and encouragement from programs like Exercising Together can help maintain participation and reduce negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Couple's Exercise Program for cancer patients because it introduces a novel way to integrate physical activity into cancer treatment. Unlike traditional exercise programs, this program encourages patients to exercise alongside their partners, leveraging live remote video conferencing for convenience and support. This approach not only aims to improve physical health but also strengthens emotional bonds and offers mutual motivation, which could enhance adherence and overall well-being during cancer treatment. Additionally, the trial collects blood samples to explore potential biological changes, offering insights into how exercise might influence cancer recovery on a molecular level.

What evidence suggests that the Exercising Together program is effective for couples during cancer treatment?

Research has shown that the "Exercising Together" program, which participants in this trial may undergo, benefits both physical and mental health for couples undergoing cancer treatment with radiation. A small initial study found that both patients and their partners became more active, with a noticeable increase in activity for the partners. In this trial, one group will participate in the structured exercise program, while another group will receive educational materials specific to exercise. Programs like Exercising Together have been linked to a higher chance of staying cancer-free for five years compared to those who only received information. This suggests that regular exercise as a couple might improve health and strengthen relationships during challenging times. ^{1 2 4 6 7}

Who Is on the Research Team?

Kerri Winters-Stone

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for couples where one partner has non-metastatic breast or prostate cancer and is set to receive radiation therapy. Both must be over 18, live together, have home internet for video calls, consent to participate, and not engage in regular strength training. They can't join if they have certain medical conditions that make moderate exercise unsafe.

Inclusion Criteria

Signed informed consent

I am scheduled for radiation therapy aimed at curing my condition at OHSU.

You live with a partner or spouse who is also willing to take part in the study.

Exclusion Criteria

I have a health condition or use medication that prevents me from doing moderate exercise.

I am able to understand and answer questions, participate in exercises, and give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Exercise Program

Participants undergo the Exercising Together program during radiation therapy, with blood sample collection throughout the trial

6 months

Regular sessions (live-remote format)

Follow-up

Participants are monitored for mental and physical health outcomes, including anxiety, physical functioning, and inflammation

6 months

Assessments at Baseline, Months 2, 4, and 6

What Are the Treatments Tested in This Trial?

Interventions

• Exercising Together

Trial Overview

The 'Exercising Together' program is being tested to see if it helps maintain physical and mental health during cancer radiation treatment. It involves a partnered exercise routine designed to strengthen the couple's relationship while improving their fitness.

How Is the Trial Designed?

Group I: Arm I (Exercise Together exercise program) Experimental Treatment 2 Interventions

Patients and partners undergo Exercising Together supervised group exercise program using live remote video conference technology over 75 minutes three times a week (TIW) for 8 weeks during radiation therapy on study. Patients also undergo collection of blood samples using self-collection methods throughout the trial.

Group II: Arm II (educational material) Active Control 2 Interventions

Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples using self collection methods throughout the trial.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

Incorporating physical exercise into the care plans of cancer patients can significantly enhance their quality of life (QOL), suggesting that exercise is a beneficial component of cancer treatment.

The development of individualized exercise plans for cancer patients requires careful screening, assessment, and collaboration among healthcare professionals, highlighting the need for further research to establish effective exercise protocols in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise as an oncology nursing intervention to enhance quality of life. Smith, SL.[2007]

Couples coping with prostate cancer who participated in a partnered exercise program (Exercising Together) experienced significant increases in affectionate behaviors among wives compared to those in a usual care group, suggesting that collaborative physical activities can enhance physical intimacy.

The study involved 64 couples over a 6-month period, but no significant changes in affectionate or sexual behaviors were observed for husbands, indicating that the benefits of partnered exercise may be more pronounced for wives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of partnered exercise on physical intimacy in couples coping with prostate cancer. Lyons, KS., Winters-Stone, KM., Bennett, JA., et al.[2018]

A study involving focus groups with persons diagnosed with breast cancer, healthcare professionals, and exercise experts identified five key themes for designing community-based exercise programs (CBEPs) that enhance cancer literacy, peer participation, and self-efficacy.

Incorporating these elements into CBEPs can improve accessibility and integration with cancer care, potentially leading to better exercise uptake and overall well-being for individuals with breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It has to be more than exercise": exploring multiple perspectives to community-based exercise program design for persons with breast cancer. Kauffeldt, KD., Sabiston, CM., Latimer-Cheung, AE., 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]

The study involves 294 couples coping with breast, prostate, or colorectal cancer, participating in a 6-month trial to assess the effectiveness of a partnered strength training program called Exercising Together© compared to other exercise formats.

The primary focus is on improving relationship quality and health outcomes for both partners, suggesting that exercising as a team may provide unique benefits over traditional exercise methods, potentially enhancing both physical and mental health for cancer survivors and their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the Exercising Together© trial: a randomized, controlled trial of partnered exercise for couples coping with cancer. Winters-Stone, KM., Lyons, KS., Dieckmann, NF., et al.[2022]

The Breast Cancer Patients Engaging in Activity and Undergoing Treatment (BEAUTY) program is a 12-week evidence-based exercise initiative designed to improve the physical and psychological well-being of women undergoing chemotherapy or radiation for breast cancer, offered at no cost to participants.

The program aims to bridge the gap between research on the benefits of exercise for breast cancer recovery and practical community implementation, ensuring safety and adherence while enhancing quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. Leach, HJ., Danyluk, JM., Culos-Reed, SN.[2022]

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]

Community-based exercise programs for cancer survivors have been shown to significantly improve quality of life, reduce fatigue, and enhance overall well-being.

Engaging in regular physical activity may also lower the risk of recurrence for certain cancers, such as breast and colon cancer, highlighting the importance of exercise in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors. Musanti, R., Murley, B.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8404361/

Study protocol for the Exercising Together© trial

The purpose of this study is to determine the unique benefits of Exercising Together© on physical, mental, and relational health in couples coping with breast, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06049355

NCT06049355 | EMBRACE: Exercising Together

Exercising Together program may be effective on the mental and physical health of couples during radiation treatment for cancer. Detailed Description. PRIMARY ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8653603/

A pilot feasibility study of Exercising Together© during ...

Total physical activity increased non-significantly for patients and significantly for spouses at post-intervention and decreased at follow-up (MD = 179.6; 95% ...

4.

bc.edu

bc.edu/bc-web/schools/cson/faculty-research/project-details/embrace-exercising-together.html

EMBRACE Exercising Together

Project Details. EMBRACE Exercising Together is a research study funded by the National Cancer Institute to examine the effects of shared physical activity ...

5.

asco.org

asco.org/about-asco/press-center/news-releases/movement-medicine-structured-exercise-program-challenge

Structured Exercise Program May Lower Risk of Cancer ...

At five years, the disease-free survival rate was 80% in the structured exercise program and 74% in the health education materials group.

6.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02279

Exercising Together During Radiation Treatment. - NCI

Exercising Together program may be effective on the mental and physical health of couples during radiation treatment for cancer. Eligibility Criteria ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03418025

Exercising Together During Radiation Treatment

This pilot clinical trial studies how well the Exercising Together program works in helping couples cope with radiation treatment for prostate cancer.