Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Determine the acceptability of the P1-CaLL intervention using a Likert scale
研究概览
简要总结
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial.
详细描述
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial. The P1-CaLL study uses a psychosocial intervention aimed at decreasing distress through the utilization of adaptive coping strategies (e.g., meditation, emotion-focused coping) and cognitive behavioral techniques. Caregivers will receive 4 weeks of stress-management sessions (over the phone). Then, they will be randomized to receive 4 more weekly sessions of either Cognitive Behavioral Therapy or Metta-Meditation (over the phone). Participants will receive tasks to complete each week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informal caregiver of a patient screening for a phase 1 clinical trial
- •Self-identifies as a caregiver as consistent with the National Study Of Caregiving (NSOC) definition13- individuals who help a patient with self-care, mobility, or household activities (the latter, for health or functioning related reasons) and are either related to the patient (paid or and non-paid) or are unrelated non-paid helpers.
- •Provision to sign and date the consent form.
- •Completes the Patient Health Questionnaire (PHQ-4) screener with a total score of >
- •Stated willingness to comply with all study procedures and be available for the duration of the study.
- •Has consistent access to a telephone
- •Able to read and understand English
排除标准
- •Has a cognitive or psychiatric condition prohibiting participation.
- •Current enrollment in another psychosocial intervention trial.
结局指标
主要结局
Determine the acceptability of the P1-CaLL intervention using a Likert scale
时间窗: Baseline to end of study period (up to one year)
Quantitatively measure the acceptability of the P1-CaLL intervention (at least fifty percent of those that complete the intervention rate it) as average or above average on a Likert Scale of Acceptability.
Assessing the feasibility of the P1-CaLL intervention by determining the percentage of recruitment and retention
时间窗: Baseline to end of study period (up to one year)
Fifty percent of those approached decide to enroll (recruitment), and fifty percent of those enrolled complete all sessions (retention).
次要结局
- PROMIS-Anxiety(Baseline to post-assessment (up to 9 weeks))
- Caregiver Burden (CRA)(Baseline to post-assessment (up to 9 weeks))
- PROMIS-Depression(Baseline to post-assessment (up to 9 weeks))
- Positive Benefit Finding (Positive Aspects of Caregiving)(Baseline to post-assessment (up to 9 weeks))
- Compassion (Compassion Scale)(Baseline to post-assessment (up to 9 weeks))
- Dysfunctional Thoughts (ATD)(Baseline to post-assessment (up to 9 weeks))
- Depression Anxiety and Stress Scale (DASS)(Baseline to post-assessment (up to 9 weeks))
- Self-Efficacy (CGI)(Baseline to post-assessment (up to 9 weeks))