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Active, Not Recruiting

NCT Number: NCT04189770

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Survivor Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Partner Prostatic Diseases Prostatic Neoplasms 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 Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerometer

Device

Wear accelerometer

ecological momentary assessment

Other

Complete EMA questionnaire

Other names: EMA

Questionnaire Administration

Other

Complete questionnaire

Survey Administration

Other

Complete survey

Primary outcomes

  1. Physical activity in both patients and partners

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

One Plus One Can Be Greater Than Two: Ecological Momentary Assessment for Black Prostate Cancer Survivors and Partners

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2019
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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