Clinical trial NCT04545021: My Health Day by Day (Mi Salud Dia a Dia)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress, Emotional
Keywords: Prostate Cancer Survivors
Cognitive Stress Management
Hispanic/Latino
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants concurrently enrolled in the parent study NCT03344757.

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.


Eligibility 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

Primary outcomes:
measure: Change in emotion regulation
timeFrame: Baseline to month 4, baseline to month 6
measure: Change in self regulation
timeFrame: Baseline to month 4, baseline to month 6
measure: Change in mindfulness attention awareness
timeFrame: Baseline to month 4, baseline to month 6
measure: Change in couple coercion
timeFrame: Baseline to month 4, baseline to month 6
measure: Change in behavioral inhibition
timeFrame: Baseline to month 4, baseline to month 6
measure: Change in behavioral activation
timeFrame: Baseline to month 4, baseline to month 6
measure: Change in relationship satisfaction
timeFrame: Baseline to month 4, baseline to month 6
measure: Heart rate variability
timeFrame: Up to Month 6
measure: Electrodermal activity
timeFrame: Up to Month 6
measure: Life satisfaction as measured by the Affective Balance Scale (ABS)
timeFrame: Up to Month 6
measure: Measure of Current Status (MOCS)
timeFrame: Up to Month 6
measure: Level of stress
timeFrame: Up to Month 6
measure: Frequency of Text messages
timeFrame: Month 6
measure: Length of Text messages
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Frank Penedo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: