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

  • STATUS
    Recruiting
  • participants needed
    95
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 16 February 2024
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cancer
stroke
dementia
exercise intervention
lung disease
nutritional assessment
lung diseases
prostate cancer stage
stage ii prostate cancer
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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.

Details
Condition spouse, Cancer Survivor, Partner, 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
Age 18years - 100years
Treatment Exercise Intervention, Informational Intervention, Interview, Nutritional Assessment, Questionnaire Administration, Telephone-Based Intervention
Clinical Study IdentifierNCT04215029
SponsorM.D. Anderson Cancer Center
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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stage iia prostate cancer
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