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NCT04215029 Clinical Trial

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

Cancer Survivor Clinical Trial

Official title:
Reducing Prostate Cancer Disparities Among African Americans

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04215029
Other study ID # 2019-0361
Secondary ID NCI-2019-0591220
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 27, 2019
Est. completion date July 31, 2024

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 6
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - To be eligible, prostate cancer survivors must self-identify as black or African American - Prostate cancer survivors must have 0-III stage prostate cancer - Prostate cancer survivors must have completed therapy (e.g., surgery, chemotherapy [chemo] and/or radiation) - Prostate cancer survivors must enroll with a spouse or a romantic partner - Prostate cancer survivors must not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week) - Prostate cancer survivors must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q) - Prostate cancer survivors must not participate in another physical activity, diet, or lifestyle program - Prostate cancer survivors must have a valid home address and telephone number - Prostate cancer survivors must be able to access internet over a smartphone or a computer at home or other location (e.g., work, church, library, community center, etc.) - To be eligible, spouses or romantic partners must be >=18 years of age - Spouses or romantic partners must enroll with a spouse or a romantic partner with prostate cancer - Spouses or romantic partners must live together with the survivors - Spouses or romantic partners must not have major health problems (e.g., cancer, dementia, stroke, and heart and lung diseases) - Spouses or romantic partners must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q) - To be eligible, healthcare providers must be currently providing care with individuals diagnosed with prostate cancer - Any professionals such as surgical and medical oncologists, fellows, nurse practitioners, physical assistants, and primary care physicians will be eligible Exclusion Criteria: - Prostate cancer survivors will be excluded if they are not married or partnered - Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site - Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer - Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period - Prostate cancer survivors will be excluded if they are on active surveillance - Prostate cancer survivors will be excluded if they enrolled in a protocol #: 2017-0556 - Prostate cancer survivors will be excluded if they are not able to understand and speak English - Spouses or romantic partners who are not able to understand and speak English will be excluded - Also, spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded - There are no exclusion criteria for healthcare providers

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise Intervention
Receive exercise plan
Other:
• Informational Intervention
Receive printed exercise materials
• Informational Intervention
Receive physical activity and healthy eating information/materials
• Interview
Participate in interview
• Nutritional Assessment
Complete nutrition counseling sessions
• Questionnaire Administration
Ancillary studies
Behavioral:
• Telephone-Based Intervention
Receive coaching calls

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (3)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center Brander Beacons Cancer Research, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men We will calculate rates of recruitment and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs) up to 6 months
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