This trial studies how well a lifestyle intervention works in reducing prostate cancer disparities among African American prostate cancer patients and their spouses or romantic partners. A lifestyle intervention may help researchers learn if social support can help African American prostate cancer patients and their partners improve their quality of life, support from their partner, physical activity, diet, and inflammation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04215029.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Dalnim Cho
Phone: 713-745-8476
PRIMARY OBJECTIVE:
I. To expand an existing couple-based behavioral intervention developed for African American (AA) or Hispanic men on active surveillance (Watchful Living; protocol #: 2017-0556) to AA prostate cancer (PCa) survivors who underwent active treatments to examine its feasibility of recruiting AA PCa survivor-partner dyads (N = 40 dyads) and implementing a lifestyle intervention.
SECONDARY OBJECTIVES:
I. Evaluate a preliminary efficacy of the intervention in improving quality of life, physical activity, nutrient intake, and inflammation.
II. Explore psychosocial mediators and moderators of the intervention.
III. Conduct a process evaluation.
IV. Assess healthcare-provider level factors (with N=15 providers) that influence both survivors’ and partners’ healthy lifestyle behaviors.
OUTLINE: Patients and their partners are randomized to 1 of 2 groups.
GROUP I: Patients and their caregivers receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their caregivers 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 caregivers complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian.
GROUP II: Patients and their caregivers receive information/materials regarding physical activity and healthy eating.
PROVIDER INTERVIEWS: Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDalnim Cho