Lifestyle Intervention for Prostate Cancer Quality of Life

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

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot trial studies how well Watchful Living works in improving quality of life in participants with prostate cancer that has not spread to other parts of the body who are on active surveillance and their partners. A social support lifestyle intervention (called Watchful Living) may help African American prostate cancer participants and their partners improve their quality of life, physical activity, diet, and inflammation.

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 data supports the effectiveness of this treatment for improving quality of life in prostate cancer patients?

Research shows that providing information support can boost self-confidence in managing prostate cancer, and healthy diet and exercise can improve quality of life and outcomes for these patients. Additionally, self-efficacy, or belief in one's ability to manage their health, is linked to better quality of life. ^{1 2 3 4 5}

Is the lifestyle intervention for prostate cancer safe?

The studies suggest that lifestyle interventions, including behavioral counseling and physical activity, are generally safe for prostate cancer survivors. Participants in these studies reported high satisfaction and adherence, with no significant adverse events noted. ^{6 7 8 9 10}

How does this lifestyle intervention treatment for prostate cancer differ from other treatments?

This lifestyle intervention treatment focuses on improving quality of life for prostate cancer patients through healthy diet and exercise, which is different from traditional medical treatments that often involve surgery, radiation, or medication. It emphasizes patient engagement and addresses barriers to lifestyle changes, particularly in diverse racial and ethnic groups, to enhance health equity. ^{2 3 11 12 13}

Research Team

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Have a valid home address and telephone number

Self-identify as black or African American or Hispanic

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

The Effect of an Information Support Program on Self-Efficacy of Prostate Cancer Patients during Hormonal Therapy. [2022]

2. Canada 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. [2023]

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

Lifestyle recommendations to prevent prostate cancer, part I: time to redirect our attention? [2013]

4. Canada 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. [2020]

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

The role of self-efficacy in quality of life for disadvantaged men with prostate cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prostate cancer survivors' preferences on the delivery of diet and lifestyle advice: a pilot best-worst discrete choice experiment. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Exploring health behaviors, quality of life, and support needs in African-American prostate cancer survivors: a pilot study to support future interventions. [2022]

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

A pilot feasibility randomized controlled trial adding behavioral counseling to supervised physical activity in prostate cancer survivors: behavior change in prostate cancer survivors trial (BOOST). [2021]

9. England pubmed.ncbi.nlm.nih.gov

Creating a teachable moment in community pharmacy for men with prostate cancer: A qualitative study of lifestyle changes. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Community pharmacy lifestyle intervention to increase physical activity and improve cardiovascular health of men with prostate cancer: a phase II feasibility study. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of dietary, nutritional, and physical activity interventions for the prevention of prostate cancer progression and mortality. [2023]

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

What should we tell prostate cancer patients about (secondary) prevention? [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Problem of Underrepresentation: Black Participants in Lifestyle Trials Among Patients with Prostate Cancer. [2022]