NCT04545021Completed
My Health Day by Day (Mi Salud Dia a Dia)
Multilevel and Ecologically Grounded Assessments of Personality, Emotions and Self- Regulation as Determinants of Psychological and Physiological Adaptation in Latino Prostate Cancer Survivors Undergoing Stress Management Training
Source: ClinicalTrials.gov · Last updated 1 Aug 2024
Brief summary (registry, in English)
The purpose of this study is to is to evaluate how Cognitive Behavioral Stress Management (CBSM) targets (e.g., anxiety reduction, cognitive reappraisal, coping, emotional expression, communication skills, social support) operate through Science of Behavior Change (SOBC) measures and influence dyadic adjustment and Health Related Quality of Life (HRQoL) in Prostate Cancer (PC) survivors and spouses/partners, in addition to physiologic adaptation and symptom burden in PC survivors.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 28 Aug 2020
- Start date
- 11 Oct 2019
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- University of Miami
- Diseases
- Prostate cancer
- NCT number
- NCT04545021
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 11 Oct 2019 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not meeting all of the inclusion criteria
Who the study is looking for
- Prostate Cancer Survivor
- ≥18 years of age
- Hispanic/Latino self- identification
- Spanish speakers (including bilinguals who agree to participate in a Spanish intervention)
- primary diagnosis of localized PC (T1-T3, N0, M0)
- surgical or radiation treatment in the past 4-months
- no history of non-skin cancer for the past 2 years
- no psychiatric treatment or overt signs of severe psychopathology (e.g., psychosis, substance dependence)
- owning a smartphone device with an Android or iPhone Operating System (iOS), which is necessary to collect the proposed Ecological Momentary Assessment (EMA) data or a valid email address.
- (I) willingness to wear the E4 wristband at 5 time points, over the course of 4 days (J) has a spouse/partner that is willing to participate or is willing to participate in the study alone
- Spouses/Partners:
- female or male ≥18 years of age
- have no history of inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis, substance dep., dementia)
- willingness to be assessed and followed for 6 months
- no life-threatening illness with a life expectancy \< 12 months
- identifies as a spouse/partner and is willing to participate in the study.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.