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

Cancer Survivor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04189770
• Other study ID #: 2019-0579
• Secondary ID: NCI-2019-0793720
• Status: Recruiting
• Start date: February 26, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Dalnim Cho
• Phone: 713-745-8476
• Email: dcho1[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Partner
• 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

Intervention

Device:
• Accelerometer
Wear accelerometer

Other:
• Ecological Momentary Assessment
Complete EMA questionnaire
• Questionnaire Administration
Complete questionnaire
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website