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

August 28, 2023 updated by: M.D. Anderson Cancer Center

Reducing Prostate Cancer Disparities Among African Americans

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • Dalnim Cho
          • Phone Number: 713-745-8476
        • Principal Investigator:
          • Dalnim Cho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (exercise plan, coaching calls, nutrition counseling)
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.
Other: Questionnaire Administration
Ancillary studies
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: Nutritional Assessment
Complete nutrition counseling sessions
Other Names:
  • dietary counseling
  • Dietary Assessment
  • nutritional counseling
Behavioral: Telephone-Based Intervention
Receive coaching calls
Active Comparator: Group II (physical activity/healthy eating information)
Patients and their partners receive information/materials regarding physical activity and healthy eating.
Other: Questionnaire Administration
Ancillary studies
Other: Informational Intervention
Receive printed exercise materials
Other: Informational Intervention
Receive physical activity and healthy eating information/materials
Experimental: Provider Interviews (interviews)
Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.
Other: Interview
Participate in interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men
Time Frame: 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)
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
Brander Beacons Cancer Research

Investigators

  • Principal Investigator: Dalnim Cho, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2019

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0361 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-05912 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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