Couple-Focused ACT Intervention for Couples Coping With Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in avoidance as measured by the Acceptance and Action Questionnaire-II
研究概览
简要总结
This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in patients with stage III-IV cancer and their partners.
详细描述
PRIMARY OBJECTIVES:
I. To examine the feasibility and acceptability of couples' acceptance and commitment therapy (ACT) (C-ACT).
II. To collect pilot data on the impact of C-ACT on patients' and partners' anxiety, depression, and quality of life.
OUTLINE:
Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months
- •Married or cohabiting with a significant other of either gender for more than one year
- •At the time of recruitment, a life expectancy of greater than 6 months and/or a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •English speaking
- •No significant hearing impairment that would prevent participation in sessions
- •Live within a 1 hour commuting distance from Rutgers Cancer Institute of New Jersey
排除标准
- •Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment
研究组 & 干预措施
Supportive Care (ACT)
Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.
干预措施: Cognitive Behavior Therapy (Behavioral)
Supportive Care (ACT)
Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (ACT)
Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.
干预措施: Questionnaire Administration (Other)
Supportive Care (ACT)
Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.
干预措施: Survey Administration (Other)
结局指标
主要结局
Change in avoidance as measured by the Acceptance and Action Questionnaire-II
时间窗: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Change in acceptance as measured by the COPE acceptance subscale
时间窗: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Change in value based living as measured by the Valued Living questionnaire
时间窗: Baseline to 1-week post intervention
Pre-post changes will be examined using t-tests in the primary outcomes as well as the mechanisms of change (e.g., flexibility, avoidance self-disclosure). Because this is primarily a pilot and feasibility study and not an efficacy test, these data will be used primarily to examine whether an impact on distress and well-being was made but statistical significance will not be the primary aim.
Feasibility defined as acceptance
时间窗: Up to 1-week post intervention
This trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 30%
Feasibility defined as session drop out
时间窗: Up to 1-week post intervention
This trial will be considered feasible if drop out from sessions (at any point over the 6 sessions) is less than 20% (thus, 6/30)
Feasibility defined as survey follow ups
时间窗: Up to 1-week post intervention
This trial will be considered feasible if 3) completion of study surveys at the follow up is 80%, and patients are not lost to progressive disease.
次要结局
未报告次要终点
研究者
Sharon Manne, PhD
Professor of Medicine
Rutgers Cancer Institute of New Jersey