- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545021
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
- Name: Dolores M Perdomo, Ph.D.
- Phone Number: 305-431-2574
- Email: dpedomo@med.miami.edu
Study Contact Backup
- Name: Madeline Hernandez-Krause
- Phone Number: 305-243-3329
- Email: madeline@miami.edu
Study Locations
-
-
Florida
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Miami, Florida, United States, 33136
- University of Miami
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-
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
- ≥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
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 |
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Cognitive Behavioral Stress Management (CBSM) - PC Survivor
Participant receives standard cognitive behavioral stress management from the Parent study NCT03344757.
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CBSM - PC Survivor Partner
The survivor partner does not receive any intervention.
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Cultural CBSM (C-CBSM) - PC Survivor
Participant receives culturally adapted cognitive behavioral stress management from the Parent study NCT03344757.
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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.
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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
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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
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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.
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Baseline to month 4, baseline to month 6
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Heart rate variability
Time Frame: Up to Month 6
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Heart rate variability collected via the Empatica wrist watch
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Up to Month 6
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Electrodermal activity
Time Frame: Up to Month 6
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Electrodermal activity collected via the Empatica wrist watch
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Up to Month 6
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Life satisfaction as measured by the Affective Balance Scale (ABS)
Time Frame: Up to Month 6
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ABS is 10 item questionnaire with a total score ranging from 0-5, with the higher score indicating higher life satisfaction.
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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.
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Up to Month 6
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Frequency of Text messages
Time Frame: Month 6
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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.
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Month 6
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Length of Text messages
Time Frame: Month 6
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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.
Sponsor
Collaborators
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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