M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT04215029
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive exercise plan
Receive printed exercise materials
Participate in interview
Complete nutrition counseling sessions
Other names: Dietary Assessment, dietary counseling, nutritional counseling
Ancillary studies
Receive coaching calls
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)
M.D. Anderson Cancer Center
Other
Reducing Prostate Cancer Disparities Among African Americans
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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