Stress, EmotionalNCT04545021
My Health Day by Day (Mi Salud Dia a Dia)
An observational study of Stress, Emotional, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants concurrently enrolled in the parent study NCT03344757.
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- 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.
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to month 4, baseline to month 6
Heart rate variability
Heart rate variability collected via the Empatica wrist watch
Measured: Up to Month 6
Electrodermal activity
Electrodermal activity collected via the Empatica wrist watch
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start11 Oct 2019
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, EmotionalStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank Penedo, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545021
- Sponsor's protocol ID
- 20190613
- Other IDs
- 1R01CA206456-01A1
- Status last verified
- Jul 2024
- First submitted
- 28 Aug 2020
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04545021
- Acronym / sponsor ID
- 20190613
- Conditions
- Stress, Emotional
- Keywords
- Prostate Cancer Survivors, Cognitive Stress Management, Hispanic/Latino
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants concurrently enrolled in the parent study NCT03344757.
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
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.
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.
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.
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.
Heart rate variability
Time frame: Up to Month 6
Heart rate variability collected via the Empatica wrist watch
Electrodermal activity
Time frame: Up to Month 6
Electrodermal activity collected via the Empatica wrist watch
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Penedo, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Emotional, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in emotion regulation (time frame: Baseline to month 4, baseline to month 6). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.