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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04215029
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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.

Study Timeline

• Study Start: 2019-08-27
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group I (exercise plan, coaching calls, nutrition counseling)	Informational Intervention	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 (physical activity/healthy eating information)	Informational Intervention	Patients and their partners receive information/materials regarding physical activity and healthy eating.
Group I (exercise plan, coaching calls, nutrition counseling)	Exercise Intervention	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 I (exercise plan, coaching calls, nutrition counseling)	Telephone-Based Intervention	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 I (exercise plan, coaching calls, nutrition counseling)	Nutritional Assessment	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 I (exercise plan, coaching calls, nutrition counseling)	Questionnaire Administration	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.
Provider Interviews (interviews)	Interview	Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.
Group II (physical activity/healthy eating information)	Questionnaire Administration	Patients and their partners receive information/materials regarding physical activity and healthy eating.

Primary Outcome Measures

Name	Time	Method
Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men	up to 6 months	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)

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States