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Completed

NCT Number: NCT04545021

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

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.

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Key information

Conditions

Stress, Emotional Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2020
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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