Clinical trial NCT04189770: Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners
Official title: One Plus One Can Be Greater Than Two: Ecological Momentary Assessment for Black Prostate Cancer Survivors and Partners
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American prostate cancer survivors and their partners

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:

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.

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

Primary outcomes:
measure: Physical activity in both patients and partners
timeFrame: Up to 14 days
measure: Nutrition in both patients and partners
timeFrame: Up to 14 days
measure: Stress in both patients and partners
timeFrame: Up to 14 days
measure: Social and physical contexts where health behaviors occur/co-occur among survivors and partners
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Dalnim Cho
role: PRINCIPAL_INVESTIGATOR
References: