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

July 26, 2023 updated by: Frank Penedo, University of Miami

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The participants concurrently enrolled in the parent study NCT03344757.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cognitive Behavioral Stress Management (CBSM) - PC Survivor
Participant receives standard cognitive behavioral stress management from the Parent study NCT03344757.
CBSM - PC Survivor Partner
The survivor partner does not receive any intervention.
Cultural CBSM (C-CBSM) - PC Survivor
Participant receives culturally adapted cognitive behavioral stress management from the Parent study NCT03344757.
Cultural CBSM (C-CBSM) - PC Survivor Partner
The survivor partner does not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in emotion regulation
Time Frame: Baseline to month 4, baseline to month 6
Change in emotion regulation will be measured using the Emotion Regulation Questionnaire (ERQ). ERQ is a 10-item questionnaire with a total score ranging from 0-70 with the higher score indicating greater use of emotional regulation strategy.
Baseline to month 4, baseline to month 6
Change in self regulation
Time Frame: Baseline to month 4, baseline to month 6
Change in self-regulation will be measured using the Short Self-Regulation Questionnaire (SSRQ). The SSRQ is a 31-item self-report questionnaire with a total score ranging from 30-150 with the higher score indicating greater self-regulation.
Baseline to month 4, baseline to month 6
Change in mindfulness attention awareness
Time Frame: Baseline to month 4, baseline to month 6
Change in mindfulness attention awareness is measured using the Mindfulness Attention Awareness Scale (MAAS). MAAS has 15 questions with a total score ranging from 15-90 with the higher score indicating higher levels of dispositional mindfulness
Baseline to month 4, baseline to month 6
Change in couple coercion
Time Frame: Baseline to month 4, baseline to month 6
Change in couple coercion is measured using the Couple Coercion Questionnaire (CCQ). The CCQ is a 12 item questionnaire with the total score ranging from 12-72, with the higher score indicating increased perception of how coercion exemplifies his/her relationship with his/her partner.
Baseline to month 4, baseline to month 6
Change in behavioral inhibition
Time Frame: Baseline to month 4, baseline to month 6
Behavioral Inhibition is measured using the Behavioral Inhibition and Activation Scale (BIS/BAS). BIS/BAS scale is a 24-item questionnaire with the BIS composing of items 2, 8, 13, 16, 19, 22 and 24. The total score for BIS has a range of 7-28 with the higher score indicating increase avoidance of aversive outcomes.
Baseline to month 4, baseline to month 6
Change in behavioral activation
Time Frame: Baseline to month 4, baseline to month 6
Behavioral Activation is measured using the Behavioral Inhibition and Activation Scale (BIS/BAS). BIS/BAS scale is a 24-item questionnaire with the BAS composing of a subset of questions with a total score ranging from of 13-52 with the higher score indicating increased motivation to approach goal-oriented outcomes.
Baseline to month 4, baseline to month 6
Change in relationship satisfaction
Time Frame: Baseline to month 4, baseline to month 6
Changes in relationship satisfaction as assessed by the Revised Dyadic Adjustment Scale (RDAS). RDAS is a 14-item measure with total scores ranging from 0-69 with the higher scores indicate greater relationship satisfaction.
Baseline to month 4, baseline to month 6
Heart rate variability
Time Frame: Up to Month 6
Heart rate variability collected via the Empatica wrist watch
Up to Month 6
Electrodermal activity
Time Frame: Up to Month 6
Electrodermal activity collected via the Empatica wrist watch
Up to Month 6
Life satisfaction as measured by the Affective Balance Scale (ABS)
Time Frame: Up to Month 6
ABS is 10 item questionnaire with a total score ranging from 0-5, with the higher score indicating higher life satisfaction.
Up to Month 6
Measure of Current Status (MOCS)
Time Frame: Up to Month 6
The MOCS questionnaire has a total score ranging from 0-52 with the higher score indicating increased likelihood of having the ability to relax at will.
Up to Month 6
Level of stress
Time Frame: Up to Month 6
Level of stress will be measured using a Likert Scale question ranging from 1-4 with the higher value indicating greater stress.
Up to Month 6
Frequency of Text messages
Time Frame: Month 6
The frequency of text messages will be reported as total amount of text messages sent and received per month, collected via Short Messaging Service (SMS) extraction software.
Month 6
Length of Text messages
Time Frame: Month 6
The length of text messages will be reported as average number of lines per text message collected via SMS extraction software
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frank Penedo, Ph.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2019

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20190613
  • 1R01CA206456-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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