This clinical 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.
Additional locations may be listed on ClinicalTrials.gov for NCT03575832.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the feasibility of recruiting and implementing a lifestyle intervention for prostate cancer patients and their partners.
SECONDARY OBJECTIVES:
I. To evaluate the preliminary efficacy of a lifestyle intervention in improving diet, physical activity, physical fitness, partner's support, quality of life, and inflammation at the end of the study (month 6).
II. To conduct a process evaluation of the lifestyle intervention.
III. Explore participants’ satisfaction, likes/dislikes, strengths, weaknesses, and areas of improvement regarding the program.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants receive an exercise plan and printed materials at baseline. Participants also receive 12 telephone coaching calls over 45-60 minutes over 6 months. Participants complete nutrition counseling sessions within 10 days and before month 3.
ARM II: Participants receive an exercise plan and printed materials at baseline.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLorna McNeill