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

Stress, Emotional Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04545021
• Other study ID #: 20190613
• Secondary ID: 1R01CA206456-01A
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Stress, Emotional

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