FAmily CEntered (FACE) Advance Care Planning for Teens With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Statement of Treatment Preferences
研究概览
简要总结
Advance Care Planning (ACP) prepares patients and their loved ones for future health care decisions, including end-of-life decisions. Yet, the needs of adolescent oncology patients for participation in ACP, despite its priority, is not well studied. Our goal is to test a model of ACP that anticipates these issues, fully empowers the family and adolescent, and keeps the key role of health care professionals central, building on our earlier work. We hypothesized FAmily CEntered (FACE) ACP, would: (1) increase congruence in treatment preferences between adolescents and surrogates; (2) decrease decisional conflict for adolescents; and (3) increase quality of communication compared with controls.
详细描述
Condition The purpose of the FACE intervention is to facilitate conversations about EOL care between adolescents and their legal guardians or surrogates in order to increase congruence in treatment preferences, to decrease decisional conflict, while supporting plans and actions, psychological adjustment and quality of life. This intervention will consist of three 60 to 90-minute sessions in a dyadic format with a trained/certified interviewer. Each session will be followed by a 15 minute assessment, using process measures to assess participants' ratings of the quality of the communication with the facilitator and satisfaction (negative and positive emotions in response to session) on a Likert scale. A research assistant, not the facilitator, will conduct the immediate post evaluation sessions. A Standard of Care comparison condition will also be assessed and measures administered at the same time intervals: at baseline, one week intervals for three weeks for process measures and Statement of Treatment Preferences, and at 3 month-post intervention follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥14.0 years and <21.0 years for adolescents at enrollment;
- •Age ≥ 21.0 years for surrogates at enrollment;
- •IQ > 70 or not known to be developmentally delayed;
- •Depression score on Beck Depression Inventory, Second Edition (BDI-II) Total Score < 26;
- •Primary language English
排除标准
- •In foster care;
- •Developmentally delayed;
- •Suicidal or homicidal or psychotic at time of screening;
- •Not understand or speak English; and
- •Failure on mini mental status exam
研究组 & 干预措施
Standard of Care (SOC) Control
Standard of Care Control: Advance Directive Information Booklet plus Advance Directive Checklist.
干预措施: Standard of Care (SOC) Control (Behavioral)
FACE Advance Care Planning
FACE intervention goal is to facilitate conversations about EOL care between adolescents and their legal guardians/surrogates to increase congruence in treatment preferences, to decrease decisional conflict, while supporting plans and actions, psychological adjustment and quality of life. Three 60 to 90-minute sessions in a dyadic format with a trained/certified interviewer. Session 1. The Lyon Family Centered Advance Care Planning Survey©. Session 2. Respecting Choices® Family-Centered Cancer Specific ACP Interview. Session 3. Completion of Five Wishes©.
干预措施: FACE (Behavioral)
结局指标
主要结局
Statement of Treatment Preferences
时间窗: Week 3
Statement of Treatment Preferences expresses values and goals related to future decision making regarding frequently occurring scenarios common to individuals dying of cancer). This instrument will be used to document specific treatment preferences of patients and the surrogate's understanding of what the patient would want. Patients and surrogates choose one of three options, "to continue all treatment and keep fighting," "to stop all treatment to prolong my life," and "don't know." It can also be used to monitor changes in patient's preferences over time. This tool has been used in adults and in adolescents in the FACE study conducted by the PI.
次要结局
- Quality of Patient-Interviewer Communication(Week 2, 3 and 4)
- Decisional Conflict Scale(Week 3)
研究者
Maureen Lyon
Associate Research Professor in Pediatrics
Children's National Research Institute