Group Exercise Program for Prostate Cancer Survivors and Caregivers

(HACER Trial)

Overseen By Marjorie Barrera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Cognitive difficulties, Pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the benefits of a group exercise program for both prostate cancer survivors and their caregivers. The program, called Exercising Together, involves partners working out in a group setting through online video sessions. Participants will exercise three times a week for three months, with a follow-up after another three months. The trial seeks Hispanic prostate cancer survivors who have completed their primary treatment and have a caregiver willing to join the exercise sessions. Both survivors and caregivers should be comfortable using video conferencing technology and able to attend sessions together. As an unphased trial, this study offers a unique opportunity to improve well-being and strengthen bonds through shared physical activity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your medication makes it unsafe to participate in moderate exercise, you may not be eligible.

What prior data suggests that the Exercising Together program is safe for prostate cancer survivors and their caregivers?

Research shows that the "Exercising Together" program is safe for participants. In earlier studies, prostate cancer survivors and their caregivers joined this exercise program and reported positive experiences. The exercise sessions did not cause any serious side effects. Participants managed the exercises well, even when performed three times a week for several months.

One study found that the program increased physical activity levels without causing major issues. This indicates that the exercises are manageable and can be safely integrated into participants' routines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Exercising Together" program for prostate cancer survivors and their caregivers because it offers a unique approach to recovery through partnered exercise. Unlike traditional treatments that focus solely on the patient, this program includes caregivers in a shared physical activity, potentially enhancing emotional bonds and mutual support. Conducted remotely in a group setting, participants can engage from the comfort of their homes, which adds convenience and encourages adherence to the exercise regimen. This holistic approach aims to improve not only physical health but also the emotional well-being of both survivors and their caregivers.

What evidence suggests that the Exercising Together program is effective for prostate cancer survivors and their caregivers?

Research shows that the "Exercising Together" program, which participants in this trial will engage in, can help prostate cancer survivors and their caregivers improve both physical and mental health. Earlier studies found that survivors who did resistance training with a partner experienced less difficulty with daily activities and improved physical abilities. The program also enhances teamwork and commitment, resulting in high attendance at sessions. It supports mental health, crucial for overall well-being. Participants often find their relationships strengthen, making the exercise sessions more enjoyable and effective. Overall, this approach supports both physical health and emotional connections. ^{1 4 5 6 7}

Who Is on the Research Team?

Meghan B Skiba, PhD, MS, MPH, RDN

Principal Investigator

University of Arizona College of Nursing Biobehavioral Health Science Division

Are You a Good Fit for This Trial?

This trial is for Hispanic individuals who have completed primary treatment for prostate cancer at least 6 weeks ago and their caregivers, who can be anyone providing unpaid support. Participants must be over 18, understand English or Spanish, able to exercise and willing to attend online classes and complete surveys.

Inclusion Criteria

Meets the American College of Sports Medicine pre-participation screening criteria for exercise

I can walk by myself or with help from devices.

I am willing to join online exercise classes, do remote assessments, and fill out surveys for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a partnered resistance training program, Exercising Together, for 3 months with supervised group exercise classes delivered remotely.

3 months

3 sessions per week (remote)

Follow-up

Participants are monitored for physical function, quality of life, and relationship health after the intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercising Together

Trial Overview The study tests the 'Exercising Together' program—a partnered resistance training routine conducted via videoconferencing software. It aims to improve physical and mental health of prostate cancer survivors and their caregivers over a period of 3 months with a follow-up after another 3 months.

How Is the Trial Designed?

Group I: Exercising Together Experimental Treatment 1 Intervention

Dyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

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 systematic review of exercise trials in prostate cancer survivors found that while 93% of studies applied the principle of specificity in exercise programming, other key principles like progression and overload were less frequently applied, indicating potential inadequacies in exercise stimulus.

Although 79% of studies reported the components of the exercise prescription, none fully reported participant adherence to the prescribed programs, highlighting a gap that could hinder understanding the optimal exercise dose for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention to the principles of exercise training in exercise studies on prostate cancer survivors: a systematic review. Neil-Sztramko, SE., Medysky, ME., Campbell, KL., et al.[2020]

A four-session individualized and supervised exercise program significantly improved various health metrics in 51 prostate cancer survivors, including muscle strength (17.6% increase) and exercise capacity (9.3% increase), indicating that even short-duration programs can be beneficial.

Participants also experienced improvements in physical function and positive well-being, suggesting that this exercise regimen is both safe and feasible for prostate cancer survivors, warranting further investigation through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a brief exercise program on the physical and psychosocial health of prostate cancer survivors: A pilot study. Skinner, TL., Peeters, GG., Croci, I., et al.[2018]

A study involving 423 prostate cancer survivors found that a self-administered implementation intention intervention significantly increased physical activity by 168 minutes per week after one month, compared to 86 minutes in the standard recommendation group.

While the self-administered approach was effective in the short term, the study suggests that combining it with additional strategies and more frequent interventions could enhance long-term exercise adherence and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a behavior change intervention to increase physical activity and quality of life in prostate cancer survivors. McGowan, EL., North, S., Courneya, KS.[2018]

A 12-week exercise program significantly improved the quality of life for 80 prostate cancer survivors, enhancing physical, emotional, social, and sexual functions while reducing treatment-related symptoms like fatigue and insomnia.

The study suggests that community-based exercise programs can effectively help prostate cancer survivors manage their symptoms and improve overall well-being, highlighting the importance of nurse-led initiatives to encourage participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the exercise programme on the quality of life of prostate cancer survivors: A randomized controlled trial. Mardani, A., Pedram Razi, S., Mazaheri, R., et al.[2021]

Citations

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

Study protocol for the Exercising Together© trial Resistance training reduces disability in prostate cancer survivors on androgen deprivation therapy: evidence from a randomized controlled trial. Arch Phys ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714411002801

The Exercising Together project: Design and recruitment ... Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06049355

NCT06049355 | EMBRACE: Exercising Together This phase II trial tests how well an exercise intervention, Exercising Together, works in preventing declines in physical and mental health in couples ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26715587/

Benefits of partnered strength training for prostate cancer ... Results: Couple retention rates were 100 % for Exercising Together and 84 % for UC. Median attendance of couples to Exercising Together sessions was 75 %. Men ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1294546/full

Adapting a dyadic exercise program to be culturally ... Exercising Together is a six-month, evidence-based dyadic resistance training program that promotes teamwork between prostate cancer survivors and their ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06018311

Hispanic Adapted and Culturally Relevant Exercising ... Self-identifies as Hispanic; Histologically confirmed prostate cancer diagnosis (self-report); Completed primary treatment at least 6 weeks prior at time of ...

7. 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% ...