Cancer SurvivorNCT04189770
Lifestyle Behavior Influences Among African American Patients With Stage 0-III Prostate Cancer Survivors and Their Partners
An observational study of Cancer Survivor and Partner, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivor, Partner, Spouse
- What is being tested?
- Accelerometer, Ecological Momentary Assessment and Questionnaire Administration
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 28 Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: African American prostate cancer survivors and their partners
Who may be able to join
- 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
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- 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
Who cannot join
- Survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Plus One Can Be Greater Than Two: Ecological Momentary Assessment for Black Prostate Cancer Survivors and 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cancer Survivor, Partner, Spouse, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8
- Being tested
- Accelerometer, Ecological Momentary Assessment, Questionnaire Administration, Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
Wear accelerometer
Ecological Momentary AssessmentOther
Also called EMA
Complete EMA questionnaire
Questionnaire AdministrationOther
Complete questionnaire
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accelerometer; Other: Ecological Momentary Assessment; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days
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.
Measured: Up to 14 days
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.
Measured: Up to 14 days
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.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start26 Feb 2020
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dalnim Cho, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189770
- Sponsor's protocol ID
- 2019-0579
- Other IDs
- NCI-2019-07937, 2019-0579, P30CA016672
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2019
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No