- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04189770
Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners
One Plus One Can Be Greater Than Two: Ecological Momentary Assessment for Black Prostate Cancer Survivors and Partners
Study Overview
Status
Conditions
- Cancer Survivor
- Stage I Prostate Cancer AJCC v8
- Stage II Prostate Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Stage IIIB Prostate Cancer AJCC v8
- Stage IIC Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Stage IIIC Prostate Cancer AJCC v8
- Stage IIA Prostate Cancer AJCC v8
- Stage IIB Prostate Cancer AJCC v8
- Partner
- Spouse
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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.
|
Complete survey
Complete questionnaire
Wear accelerometer
Complete EMA questionnaire
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 14 days
|
|
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.
|
Up to 14 days
|
|
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.
|
Up to 14 days
|
|
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.
|
Up to 14 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dalnim Cho, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0579 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2019-07937 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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