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

Trial Summary

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 data supports the effectiveness of the treatment Exercising Together, EMBRACE, Exercising Together Program for cancer?

Research suggests that including partners in exercise programs can improve physical and mental health, as well as relationship quality for cancer survivors and their partners. A study found that couples participating in the Exercising Together program experienced higher levels of physical intimacy compared to those who did not, indicating potential benefits for relational health. ^{1 2 3 4 5}

Is the Couple's Exercise Program for Cancer safe for participants?

The Couple's Exercise Program, also known as Exercising Together, has been designed to be safe for participants, as evidenced by similar community-based exercise programs for cancer patients that focus on safety and adherence. These programs aim to improve physical and mental well-being without compromising safety. ^{2 5 6 7 8}

How is the Exercising Together treatment unique for cancer patients?

The Exercising Together program is unique because it involves cancer survivors and their partners exercising as a team, which aims to improve not only their physical and mental health but also the quality of their relationship. This partnered approach is different from traditional exercise programs that focus on individual or group training without the relational component. ^{2 4 5 6 9}

What is the purpose of this trial?

This phase II trial tests how well an exercise intervention, Exercising Together, works in preventing declines in physical and mental health in couples during radiation treatment for cancer. Treatments for cancer can cause side effects such as fatigue as well as strain on relationships. Exercising Together is a partnered exercise program that adds communication, collaboration and support between partners during exercise to fortify the relationship and amplify the benefits of physical training. Exercising Together program may be effective on the mental and physical health of couples during radiation treatment for cancer.

Research Team

Kerri Winters-Stone

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

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

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

The effects of partnered exercise on physical intimacy in couples coping with prostate cancer. [2018]

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

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

4. 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]

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

Study protocol for the Exercising Together© trial: a randomized, controlled trial of partnered exercise for couples coping with cancer. [2022]

6. Germany 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. [2022]

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

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

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

Community-Based Exercise Programs for Cancer Survivors. [2018]