NCT04189770

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

December 3, 2019

Last Update Submit

January 12, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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: AccelerometerOther: Ecological Momentary AssessmentOther: Questionnaire AdministrationOther: Survey Administration

Interventions

Wear accelerometer

Observational (questionnaire, accelerometer, EMA, survey)

Complete EMA questionnaire

Also known as: EMA
Observational (questionnaire, accelerometer, EMA, survey)

Complete questionnaire

Observational (questionnaire, accelerometer, EMA, survey)

Complete survey

Observational (questionnaire, accelerometer, EMA, survey)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African American prostate cancer survivors and their partners

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Dalnim Cho

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 6, 2019

Study Start

February 26, 2020

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations