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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04545021
Other study ID # 20190613
Secondary ID 1R01CA206456-01A
Status Active, not recruiting
Phase
First received
Last updated
Start date October 11, 2019
Est. completion date July 31, 2024

Study information

Verified date July 2023
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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