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NCT04189770 Clinical Trial

Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners

Cancer Survivor Clinical Trial

Official title:
One Plus One Can Be Greater Than Two: Ecological Momentary Assessment for Black Prostate Cancer Survivors and Partners

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04189770
Other study ID # 2019-0579
Secondary ID NCI-2019-0793720
Status Recruiting
Phase
First received
Last updated
Start date February 26, 2020
Est. completion date February 28, 2024

Study information
Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Dalnim Cho
Phone 713-745-8476
Email dcho1@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This trial studies the day-to-day stress, social support, and health lifestyle behaviors (such as physical activity and nutrition) in African American patients with stage 0-III prostate cancer survivors and their partners. How patients cope with stress may affect their lifestyle behaviors. This study may help understand not only survivors' behaviors but also partners' behaviors and how they interact.

Description:

PRIMARY OBJECTIVES: I. Examine temporal associations between dyadic coping and health behaviors such as physical activity and diet. II. Identify social and physical contexts in which health behaviors occur/co-occur among survivors and their partners. EXPLORATORY OBJECTIVE: I. Investigate potential moderators for the associations between stress and dyadic coping. OUTLINE: Patients and partners complete questionnaires over 60 minutes about demographic information, stress, coping, and lifestyle behaviors at baseline and end of study. Patients and partners also receive an accelerometer and complete Ecological Momentary Assessment (EMA) questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes four time daily (QID; 7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone application (app) for 14 days. Patients and partners also complete a survey on nutrition twice weekly (BIW) for a total of 4 surveys.

Recruitment information / eligibility
Status Recruiting
Enrollment 240
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Survivors are eligible if they self-identify as African American adults - Had stage 0-III prostate cancer (no restriction on time elapsed since diagnosis) - Completed adjuvant therapy (i.e., chemo and/or radiation therapy) - Live together with a current partner/spouse who is eligible for the study - Do not need physical assistance (e.g., wheelchair, cane) - Have a smartphone - Can read and speak English - Currently are not participating in a health behavior or weight management program - Men on active surveillance will be included - Partners are eligible if they are adults - Partners are eligible if they do not have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia) - Partners are eligible if they have a smartphone - Partners are eligible if they can read and speak English - Partners are eligible if they currently are not participating in a health behavior or weight management program - The dyad can be either married or unmarried and same-sex or heterosexual Exclusion Criteria: - Survivors will be excluded if they had a prior history of other cancer or have metastatic cancer

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Accelerometer
Wear accelerometer
Other:
• Ecological Momentary Assessment
Complete EMA questionnaire
• Questionnaire Administration
Complete questionnaire
• Survey Administration
Complete survey

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physical activity in both patients and partners To assess the association between the common dyadic coping of partner or survivor and physical activity of the survivor or partner, will construct 2 new variables corresponding to each common dyadic coping variable for each individual. Up to 14 days
Primary Nutrition in both patients and partners To assess the association between the common dyadic coping of partner or survivor and nutrition of the survivor or partner, will construct 2 new variables corresponding to each common dyadic coping variable for each individual. Up to 14 days
Primary Stress in both patients and partners To assess the association between the common dyadic coping of partner or survivor and nutrition of the survivor or partner, will construct 2 new variables corresponding to each common dyadic coping variable for each individual. Up to 14 days
Primary Social and physical contexts where health behaviors occur/co-occur among survivors and partners Descriptive analysis (e.g., frequency) will be conducted to examine the places (e.g., home, neighborhood) in which the health behaviors occurred and the number of health behaviors engaged alone and with others (especially with partner). Also, contexts (days of a week and times of a day and place) in which survivors and partners engaged in health behaviors together will be investigated. All analyses will be exploratory in nature. Up to 14 days
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