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

Recruiting

• Conditions: Partner; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Spouse; Stage II Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Cancer Survivor; Stage I Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8
• Interventions: Device: Accelerometer; Other: Ecological Momentary Assessment; Other: Questionnaire Administration; Other: Survey Administration

• Registration Number: NCT04189770
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Study Start: 2020-02-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

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Exclusion Criteria

• Survivors will be excluded if they had a prior history of other cancer or have metastatic cancer

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, accelerometer, EMA, survey)	Accelerometer	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 EMA questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes QID (7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone app for 14 days. Patients and partners also complete a survey on nutrition BIW for a total of 4 surveys.
Observational (questionnaire, accelerometer, EMA, survey)	Questionnaire Administration	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 EMA questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes QID (7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone app for 14 days. Patients and partners also complete a survey on nutrition BIW for a total of 4 surveys.
Observational (questionnaire, accelerometer, EMA, survey)	Ecological Momentary Assessment	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 EMA questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes QID (7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone app for 14 days. Patients and partners also complete a survey on nutrition BIW for a total of 4 surveys.
Observational (questionnaire, accelerometer, EMA, survey)	Survey Administration	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 EMA questionnaire on stress, coping, physical activity, and eating behaviors over 5-10 minutes QID (7:30 am, 11:30 am, 3:30 pm, and 7:30 pm) via an smartphone app for 14 days. Patients and partners also complete a survey on nutrition BIW for a total of 4 surveys.

Primary Outcome Measures

Name	Time	Method
Physical activity in both patients and partners	Up to 14 days	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.
Nutrition in both patients and partners	Up to 14 days	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.
Stress in both patients and partners	Up to 14 days	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.
Social and physical contexts where health behaviors occur/co-occur among survivors and partners	Up to 14 days	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States