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

Clinicaltrials.gov ID: NCT04189770
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 240

Conditions

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

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Dalnim Cho
  • 713-745-8476

Principal Investigator

  • Dalnim Cho

Eligibility Criteria

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 Plan

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.

  • DEVICE:

    Accelerometer

    Description:

    Wear accelerometer
  • OTHER:

    Ecological Momentary Assessment

    Description:

    Complete EMA questionnaire
  • OTHER:

    Questionnaire Administration

    Description:

    Complete questionnaire
  • OTHER:

    Survey Administration

    Description:

    Complete survey

Outcome Measures

Primary Outcome Measures

Physical activity in both patients and partners

Time Frame: Up to 14 days

Nutrition in both patients and partners

Time Frame: Up to 14 days

Stress in both patients and partners

Time Frame: Up to 14 days

Social and physical contexts where health behaviors occur/co-occur among survivors and partners

Time Frame: Up to 14 days

Timeline

  • Last Updated
    August 15, 2024
  • Start Date
    December 6, 2019
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    February 28, 2026

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