NCT04215029

Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans

Reducing Prostate Cancer Disparities Among African Americans

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 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 II: Patients and their partners 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.

Conditions

• Cancer Survivor
• Partner
• Spouse
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage IIA Prostate Cancer AJCC v8
• Stage IIB Prostate Cancer AJCC v8
• Stage IIC Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	Receive exercise plan
OTHER	Informational Intervention	Receive printed exercise materials
OTHER	Informational Intervention	Receive physical activity and healthy eating information/materials
OTHER	Interview	Participate in interview
OTHER	Nutritional Assessment	Complete nutrition counseling sessions
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive coaching calls

Timeline

• Start date: 2019-08-27
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2020-01-02
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States