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ClinicalTrials.gov Identifier: NCT04545021
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : December 3, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Frank Penedo, University of Miami

Study Description
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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
Stress, Emotional

Study Design
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Study Type : Observational
Estimated 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 : October 11, 2019
Estimated Primary Completion Date : October 11, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  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.

  7. 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.

  8. Heart rate variability [ Time Frame: Up to Month 6 ]
    Heart rate variability collected via the Empatica wrist watch

  9. Electrodermal activity [ Time Frame: Up to Month 6 ]
    Electrodermal activity collected via the Empatica wrist watch

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The participants concurrently enrolled in the parent study NCT03344757.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545021


Contacts
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Contact: Dolores M Perdomo, Ph.D. 305-431-2574 dpedomo@med.miami.edu
Contact: Madeline Hernandez-Krause 305-243-3329 madeline@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Dolores M Perdomo, Ph.D.    305-431-2574    dperdomo@med.miami.edu   
Contact: Madeline Hernandez-Krause    305-243-3329    madeline@miami.edu   
Principal Investigator: Frank Penedo, Ph.D         
Sponsors and Collaborators
University of Miami
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Frank Penedo, Ph.D. University of Miami
More Information
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Responsible Party: Frank Penedo, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04545021    
Other Study ID Numbers: 20190613
1R01CA206456-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frank Penedo, University of Miami:
Prostate Cancer Survivors
Cognitive Stress Management
Hispanic/Latino