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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in mindfulness attention awareness
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Not meeting all of the inclusion criteria
结局指标
主要结局
Change in mindfulness attention awareness
时间窗: 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
Heart rate variability
时间窗: Up to Month 6
Heart rate variability collected via the Empatica wrist watch
Change in relationship satisfaction
时间窗: 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.
Change in behavioral activation
时间窗: 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 emotion regulation
时间窗: 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
时间窗: 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 couple coercion
时间窗: 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.
Life satisfaction as measured by the Affective Balance Scale (ABS)
时间窗: 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.
Frequency of Text messages
时间窗: 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.
Change in behavioral inhibition
时间窗: 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.
Electrodermal activity
时间窗: Up to Month 6
Electrodermal activity collected via the Empatica wrist watch
Measure of Current Status (MOCS)
时间窗: 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
时间窗: 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.
Length of Text messages
时间窗: Month 6
The length of text messages will be reported as average number of lines per text message collected via SMS extraction software
次要结局
未报告次要终点
研究者
Frank Penedo
Professor
University of Miami