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

NCT04545021 | Completed

• 2 other identifiers: 201906131R01CA206456-01A1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Emotional

Keywords

Prostate Cancer Survivors; Cognitive Stress Management; Hispanic/Latino

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Heart rate variability

  Heart rate variability collected via the Empatica wrist watch

  Up to Month 6

• Electrodermal activity

  Electrodermal activity collected via the Empatica wrist watch

  Up to Month 6

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participants concurrently enrolled in the parent study NCT03344757.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Frank Penedo, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 10, 2020
• Study Start: October 11, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)