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Lifestyle Changes for Prostate Cancer

N/A

Waitlist Available

Led By Dalnim Cho

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate cancer survivors must not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week)

Prostate cancer survivors must not participate in another physical activity, diet, or lifestyle program

Must not have

Spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded

Spouses or romantic partners who are not able to understand and speak English will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a lifestyle intervention can help African American prostate cancer patients and their partners improve their quality of life, support from their partner, physical activity, diet, and inflammation.

Who is the study for?

This trial is for African American prostate cancer survivors who've finished therapy, and their spouses or partners. Participants must be underactive in physical activity, not involved in other lifestyle programs, and have internet access. Partners must live together without major health issues. Healthcare providers treating prostate cancer are also eligible.

What is being tested?

The study tests a lifestyle intervention to see if it helps improve the quality of life, partner support, physical activity levels, diet habits, and reduces inflammation among African American men with prostate cancer and their partners.

What are the potential side effects?

Since this trial involves lifestyle changes like exercise and nutrition rather than medication or medical procedures, side effects may include muscle soreness from increased physical activity or changes in digestion due to dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do less than 150 minutes of moderate exercise weekly.

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I am a prostate cancer survivor not enrolled in any other health program.

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I am a prostate cancer survivor with a valid home address and phone number.

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My prostate cancer is at stage 0 to III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My partner and I have not both enrolled in protocol #2017-0556.

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My spouse or partner and I can both understand and speak English.

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I do not have any active cancer other than in my prostate.

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I am a prostate cancer survivor not planning any cancer treatment during the study.

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I have prostate cancer but no history of other cancers or metastatic disease.

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I am a prostate cancer survivor and I am married or in a partnership.

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I am not on active surveillance for prostate cancer.

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I am a prostate cancer survivor who speaks and understands English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Provider Interviews (interviews)Experimental Treatment1 Intervention

Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.

Group II: Group I (exercise plan, coaching calls, nutrition counseling)Experimental Treatment5 Interventions

Patients and their partners receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their partners also receive coaching calls discussing physical activity and diet related questions, each lasting 45-60 minutes and occurring every 2 weeks for 6 months. In addition, patients and their partners complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian.

Group III: Group II (physical activity/healthy eating information)Active Control2 Interventions

Patients and their partners receive information/materials regarding physical activity and healthy eating.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telephone-Based Intervention

2017

Completed Phase 2

~3400

Exercise Intervention

2016