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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04189770
Collaborator
National Cancer Institute (NCI) (NIH)
240
1
34.2
7

Study Details

Study Description

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:
  1. Examine temporal associations between dyadic coping and health behaviors such as physical activity and diet.

  2. Identify social and physical contexts in which health behaviors occur/co-occur among survivors and their partners.

EXPLORATORY OBJECTIVE:
  1. 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 Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
One Plus One Can Be Greater Than Two: Ecological Momentary Assessment for Black Prostate Cancer Survivors and Partners
Actual Study Start Date :
Feb 26, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Wear accelerometer

Other: Ecological Momentary Assessment
Complete EMA questionnaire
Other Names:
  • EMA
  • Other: Questionnaire Administration
    Complete questionnaire

    Other: Survey Administration
    Complete survey

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Dalnim Cho, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04189770
    Other Study ID Numbers:
    • 2019-0579
    • NCI-2019-07937
    • 2019-0579
    • P30CA016672
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2022