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Clinical Trial Summary

The goal of this study is to learn if a social support lifestyle intervention (called Watchful Living) can help African American prostate cancer patients and their partners improve their quality of life, physical activity, diet, and inflammation.

This is an investigational study.

Up to 80 participants (40 patients and their partners) will be enrolled in this part of the study. All will take part at MD Anderson.

Clinical Trial Description

Baseline Visit:

If you agree to take part in this study, the following procedures will be performed at your baseline (first) visit:

- You will complete a computer-based questionnaire about your age, education, social status, health status, mood, diet, level of physical activity, and quality of life. The questionnaire should take 45 minutes to complete.

- Blood (about 2 teaspoons) will be drawn to measure inflammation in the body that may be linked to health problems, such as diabetes and high levels of cholesterol.

- You will be given a pedometer which is a small device worn on the hip that counts the number of steps you have taken each day.

- You will complete a physical fitness test. During this test, your upper and lower body strength and endurance will be measured. Among other tests, you will used a hand grip to test your upper body strength, walk about 400 meters at a fast pace, and be asked to sit down in a chair and stand up as many times as possible within a certain amount of time. This fitness test should take about 15 minutes to complete.

- You will be given a blinded accelerometer. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do. However, a blinded accelerometer means that you will not be able to see the results of the accelerometer, so you will not know how much physical activity the accelerometer has measured. You will be given a self-addressed prepaid envelope to return the accelerometer to the study staff after you have worn it for 7 days.

Home-Based Physical Activity Program:

During your baseline study visit, you will also receive an exercise plan and printed materials, which will include instructions for walking (or other moderate-intensity activities if walking is difficult for you). These are activities that you can do on your own at home.

After your baseline visit, you and your partner will receive 10 telephone coaching calls lasting about 45-60 minutes each. Coaching calls will occur every week during Month 1, every 2 weeks during Month 2, and every month during Months 3-6. A health coach will discuss physical activity and diet-related questions or concerns with you and your partner.

You may choose to stop receiving coaching calls at any time. If you choose to stop receiving coaching calls this will not impact your ability to continue participation in the study.

Nutrition Counseling:

You and your partner will complete 2 nutrition counseling sessions with an MD Anderson registered dietitian. The first session will occur in-person at your baseline visit. The second session will occur before Month 3 over the phone at a time that is convenient for you and your partner. During nutrition counseling, you will discuss goals, objectives, lifestyles, and current eating habits with the dietitian.

Study Visits:

About 3 and 6 months after the baseline visit:

- You will complete the computer-based questionnaires.

- You will be given an accelerometer that will measure the amount of physical activity you do over the next 7 days. For Month 3 the device will be mailed to you. You will be given a self-addressed prepaid envelope to return the accelerometer to the study staff after you have worn it for 7 days. For Month 6 you will receive the device 1 week before and return it at your Month 6 visit.

- Blood (about 2 teaspoons) will be drawn to measure inflammation in the body that may be linked to health problems, such as diabetes and high levels of cholesterol (Month 6 only).

- You will complete a physical fitness test (Month 6 only).

Some participants may be invited to participate in a group discussion called a focus group about two months after the Month 6 visit. The focus group will be made up of 10 study participants, and will be led by a study staff member who will ask questions about how you feel in general and what you thought about the study. This focus group may last up to 2 hours.

The focus group will be audio recorded and then transcribed (written down) without your name or any other identifying information. The digital audio files will be destroyed after they are transcribed.

Length of Study:

Participation in this study for most participants will be over after the study visit at Month 6, but may last up to a total of 8 months for those who participate in the follow-up focus group. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03575832
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Lorna H. McNeill, PHD, MPH
Phone 713-563-1103
Status Recruiting
Phase N/A
Start date January 25, 2018
Completion date August 2019

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