Lifestyle Intervention for Prostate Cancer Quality of Life

Not currently recruiting at 1 trial location

Overseen By Lorna McNeill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunotherapy, Hormonal therapy, Chemotherapy

Disqualifiers: Noncutaneous malignancy, Prior radiation, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a lifestyle program called Watchful Living can improve the quality of life for African American or Hispanic men with early-stage prostate cancer and their partners. The program includes exercise plans, nutrition counseling, and regular coaching calls. It aims to boost physical activity, diet, and overall well-being. Ideal participants are those who haven't met recommended exercise levels and are on active surveillance for prostate cancer. Participants should also be ready to get active and have internet access.

As an unphased trial, this study offers a unique opportunity to enhance lifestyle and well-being while contributing to valuable research.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not have planned treatments like immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study.

What prior data suggests that this lifestyle intervention is safe for improving quality of life in prostate cancer patients?

Research has shown that supportive care treatments, such as exercise and nutrition counseling, are generally safe and manageable. Studies have found that these activities can significantly improve health without causing serious side effects.

For instance, a program that included group exercise and dietary advice led to better health outcomes without any major issues. Another study found that similar programs, offered by phone or in person, were safe and effective for prostate cancer patients.

Overall, evidence suggests that the supportive care approach used in this trial is safe for participants and can enhance their quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how lifestyle interventions, such as exercise and nutrition counseling, can improve the quality of life for prostate cancer patients. Unlike conventional treatments that often focus on medication or surgery, this approach emphasizes personalized, supportive care through a structured plan of exercise and nutrition, delivered via telephone coaching. This method could empower patients to actively participate in their care and potentially experience improvements in their overall well-being and management of side effects from traditional treatments.

What evidence suggests that this trial's interventions could improve quality of life for prostate cancer patients?

This trial will evaluate supportive care involving exercise and nutrition counseling for prostate cancer survivors. Research has shown that exercise and nutrition counseling can help these survivors become more active. One study found that participants who followed a planned diet and exercise routine increased their activity levels. Another study found that healthy eating and regular exercise helped reduce cancer-related fatigue, improving quality of life. However, some reviews suggest that while activity levels increased, the direct effect on cancer-specific quality of life remains less clear. Overall, these approaches offer promising ways to support better health and well-being for those with prostate cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for African American or Hispanic couples where one partner has localized prostate cancer (stages 0-III) and is on active surveillance. Both must be over 18, have internet access, not meet physical activity recommendations, and agree to not join other lifestyle programs. Patients should have finished any prior therapy and can't be receiving certain treatments during the study.

Inclusion Criteria

My prostate cancer is at stage 0 to III.

Self-identify as black or African American or Hispanic

Have a valid home address and telephone number

Exclusion Criteria

Are enrolled in another active surveillance protocol

Participated in formative focus groups for this study (patient and spouse or intimate partner)

I am scheduled for additional cancer treatments like immunotherapy or chemotherapy during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants receive an exercise plan and printed materials

1 week

Intervention

Participants receive 10 telephone coaching calls and 2 nutrition counseling sessions

6 months

10 calls (telephone), 2 sessions (nutrition counseling)

Follow-up

Participants are monitored for adherence and lifestyle changes

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• Informational Intervention
• Telephone-Based Intervention

Trial Overview The 'Watchful Living' program aims to improve quality of life for patients with localized prostate cancer and their partners through a social support lifestyle intervention. It includes telephone-based counseling, educational materials, assessments of well-being, and questionnaires administered over time.

How Is the Trial Designed?

Group I: Supportive care (exercise, nutrition counseling) Experimental Treatment 5 Interventions

Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 14 men from diverse racial and ethnic backgrounds highlighted the importance of understanding patients' social contexts, motivations, and preparedness for lifestyle changes to improve diet and exercise interventions for men with advanced prostate cancer.

Recommendations for future mobile health (mHealth) interventions include tailoring programs to individual needs based on their home environment, access to resources, and health literacy, which can enhance engagement and effectiveness in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Men of Diverse Racial and Ethnic Groups With Advanced Prostate Cancer in the Design of an mHealth Diet and Exercise Intervention: Focus Group Study. Wang, EY., Borno, HT., Washington Iii, SL., et al.[2023]

The Community of Wellness is a Web-based intervention designed to support prostate cancer survivors in improving their physical activity and dietary habits, with a randomized controlled trial currently enrolling 200 participants to assess its feasibility and acceptability.

Preliminary results will help determine the most effective level of online support needed to promote health behavior changes in men with prostate cancer, potentially informing future scalable health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. Winters-Stone, KM., Kenfield, SA., Van Blarigan, EL., et al.[2020]

Lifestyle factors after a prostate cancer diagnosis, such as smoking and obesity, are linked to increased risks of disease progression and mortality, highlighting the importance of lifestyle management post-diagnosis.

Engaging in vigorous physical activity, walking briskly, and consuming a diet rich in vegetables and healthy fats may lower the risk of prostate cancer progression and improve overall survival, suggesting that these behaviors should be prioritized in patient counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we tell prostate cancer patients about (secondary) prevention? Chan, JM., Van Blarigan, EL., Kenfield, SA.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6361261/

Effects of a Group-Mediated Exercise and Dietary ... Quality of life in prostate cancer ... A systematic review of physical activity in prostate cancer survivors: Outcomes, prevalence, and determinants.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00044980

Diet and Exercise-Based Counseling Program Compared ... Long-term outcomes of the FRESH START trial: exploring the role of self-efficacy in cancer survivors' maintenance of dietary practices and physical activity.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125006792

Effectiveness in physical activity levels of Proactive ... The results of this study indicated a significant improvement in physical activity levels of prostate cancer survivors after implementing ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5622763/

The Effect of Nutrition Therapy and Exercise on Cancer ... Prescribing healthy eating guidelines with combined resistance training and aerobic exercise improved cancer-related fatigue, yet its effect on quality of life ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/15347354211063500

Quality of Life of Prostate Cancer Survivors Participating in ... In this analysis of secondary outcomes, we observed little change in cancer-specific QoL outcomes among prostate cancer survivors participating ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39081227/

Weight loss interventions for patients with prostate cancer Most interventions included both dietary and physical activity components and were delivered 1-on-1 in-person and/or by telephone. Most of the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03880422

Nutrition and Exercise Interventions in Reducing Androgen ... This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer ...

8. mdpi.com mdpi.com/2072-6643/9/9/1003

The Effect of Nutrition Therapy and Exercise on Cancer- ... Advances in treatment for prostate cancer have improved prostate cancer-specific survival, with 5–10-year disease-free survival rates in Western countries now ...