My Health Day by Day (Mi Salud Dia a Dia)

University of Miami

Status: Completed

Conditions: Stress, Emotional

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04545021

20190613

1R01CA206456-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Prostate Cancer Survivor

1. ≥18 years of age
2. Hispanic/Latino self- identification
3. Spanish speakers (including bilinguals who agree to participate in a Spanish intervention)
4. primary diagnosis of localized PC (T1-T3, N0, M0)
5. surgical or radiation treatment in the past 4-months
6. no history of non-skin cancer for the past 2 years
7. no psychiatric treatment or overt signs of severe psychopathology (e.g., psychosis, substance dependence)
8. 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:

1. female or male ≥18 years of age
2. have no history of inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis, substance dep., dementia)
3. willingness to be assessed and followed for 6 months
4. no life-threatening illness with a life expectancy < 12 months
5. identifies as a spouse/partner and is willing to participate in the study.

Exclusion criteria

• Not meeting all of the inclusion criteria

Trial design

200 participants in 4 patient groups

Cognitive Behavioral Stress Management (CBSM) - PC Survivor

Description:

Participant receives standard cognitive behavioral stress management from the Parent study NCT03344757.

CBSM - PC Survivor Partner

Description:

The survivor partner does not receive any intervention.

Cultural CBSM (C-CBSM) - PC Survivor

Description:

Participant receives culturally adapted cognitive behavioral stress management from the Parent study NCT03344757.

Cultural CBSM (C-CBSM) - PC Survivor Partner

Description:

The survivor partner does not receive any intervention.