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

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04545021

Collaborator

National Cancer Institute (NCI) (NIH)

240

Enrollment

Location

39.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Emotional

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 11, 2019

Anticipated Primary Completion Date :

Oct 11, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Change in emotion regulation [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.
Change in self regulation [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.
Change in mindfulness attention awareness [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
Change in couple coercion [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.
Change in behavioral inhibition [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.
Change in behavioral activation [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.
Change in relationship satisfaction [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.
Heart rate variability [Up to Month 6]
Heart rate variability collected via the Empatica wrist watch
Electrodermal activity [Up to Month 6]
Electrodermal activity collected via the Empatica wrist watch
Life satisfaction as measured by the Affective Balance Scale (ABS) [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.
Measure of Current Status (MOCS) [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.
Level of stress [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.
Frequency of Text messages [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.
Length of Text messages [Month 6]
The length of text messages will be reported as average number of lines per text message collected via SMS extraction software

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

Not meeting all of the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami
National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frank Penedo, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04545021

Other Study ID Numbers:

20190613
1R01CA206456-01A1

First Posted:

Sep 10, 2020

Last Update Posted:

Dec 3, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Frank Penedo, Professor, University of Miami

Prostate Cancer Survivors

Cognitive Stress Management

Hispanic/Latino

Study Results

No Results Posted as of Dec 3, 2021