Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans
NCT ID: NCT04215029
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
6 participants
INTERVENTIONAL
2019-08-27
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Exercise Intervention
Receive exercise plan
Informational Intervention
Receive printed exercise materials
Nutritional Assessment
Complete nutrition counseling sessions
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Receive coaching calls
Group II (physical activity/healthy eating information)
Patients and their partners receive information/materials regarding physical activity and healthy eating.
Informational Intervention
Receive physical activity and healthy eating information/materials
Questionnaire Administration
Ancillary studies
Provider Interviews (interviews)
Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.
Interview
Participate in interview
Interventions
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Exercise Intervention
Receive exercise plan
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
Telephone-Based Intervention
Receive coaching calls
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Brander Beacons Cancer Research
UNKNOWN
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dalnim Cho
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-05912
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0361
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0361
Identifier Type: -
Identifier Source: org_study_id
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