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

NCT04215029 | Active Not Recruiting

• 2 other identifiers: 2019-0361NCI-2019-05912
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group I (exercise plan, coaching calls, nutrition counseling)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Other: Informational Intervention; Other: Nutritional Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Group II (physical activity/healthy eating information)

ACTIVE COMPARATOR

Patients and their partners receive information/materials regarding physical activity and healthy eating.

Other: Informational Intervention; Other: Questionnaire Administration

Provider Interviews (interviews)

EXPERIMENTAL

Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.

Other: Interview

Interventions

Exercise Intervention BEHAVIORAL

Receive exercise plan

Group I (exercise plan, coaching calls, nutrition counseling)

Informational Intervention OTHER

Receive printed exercise materials

Group I (exercise plan, coaching calls, nutrition counseling)

Interview OTHER

Participate in interview

Provider Interviews (interviews)

Nutritional Assessment OTHER

Complete nutrition counseling sessions

Also known as: Dietary Assessment, dietary counseling, nutritional counseling

Group I (exercise plan, coaching calls, nutrition counseling)

Questionnaire Administration OTHER

Ancillary studies

Group I (exercise plan, coaching calls, nutrition counseling); Group II (physical activity/healthy eating information)

Telephone-Based Intervention BEHAVIORAL

Receive coaching calls

Group I (exercise plan, coaching calls, nutrition counseling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Brander Beacons Cancer Research: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interviews as Topic; Nutrition Assessment

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Epidemiologic Measurements

Study Officials

• Dalnim Cho

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: January 2, 2020
• Study Start: August 27, 2019
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)