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

NCT ID: NCT04189770

Last Updated: 2026-01-14

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-26

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Cancer Survivor Partner Spouse 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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (questionnaire, accelerometer, EMA, survey)

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.

Ecological Momentary Assessment

Intervention Type OTHER

Complete EMA questionnaire

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

Survey Administration

Intervention Type OTHER

Complete survey

Accelerometer

Intervention Type DEVICE

Wear accelerometer

Interventions

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Ecological Momentary Assessment

Complete EMA questionnaire

Intervention Type OTHER

Questionnaire Administration

Complete questionnaire

Intervention Type OTHER

Survey Administration

Complete survey

Intervention Type OTHER

Accelerometer

Wear accelerometer

Intervention Type DEVICE

Other Intervention Names

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EMA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-07937

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-0579

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-0579

Identifier Type: -

Identifier Source: org_study_id

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