Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness to Patient With Terminal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 28
- 主要终点
- Decisional conflict & satisfaction: Decisional Conflict Scale
研究概览
简要总结
This study is a randomized controlled trial that will compare two arms: an experimental intervention group that receives a decision aid consisting of an educational video and targeted manual providing a protocol for the family members' disclosing terminal illness to the patients and aimed at improving communication, satisfaction with decision making process, and quality of life between patients and their family versus an attention control group that receives a video and non-tailored manual on pain control.
详细描述
Inclusion and exclusion criteria:
This study is aimed at decreasing the decisional conflict among family members who are ready or not to disclose patients' terminal illness. The decision aid will lead to effective communication between patients and family and the effective decision making process will lead to the final outcome to improve the quality of life in patients and their family. This trial is limited to situations where the family and their patients are cognitively capable of participating in decision-making process.
Measures:
Baseline Measures. At baseline, before randomization, self-reported questionnaire is used to collect data. To correct possible confounders in this study, family' background variables are assessed on entry to the study, including sociodemographic and decisional conflicts, decisional-role preference, stage of readiness, level of anxiety and depression, and QOL.
Family decisional conflict is assessed using four subscales of the Decisional Conflict Scale which assessed how well informed participants feel about their choices and the associated benefits and risks; the clarity of their values; the support they have in the decision-making process; and their level of uncertainty. It consists of 16 items followed by a Likert response of 1, strongly agree, to 5, strongly disagree. A mean score is obtained for each participant. The Decisional Conflict Scale (DCS) is translated into Korean by two bilingual individuals, using a forward-backward translation procedure, and completed pilot test.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥ 18years
- •cancer patient
- •terminally ill
- •mentally competent
- •Family members:
- •age≥ 18years
- •having terminally ill cancer patients
- •Spouse, daughter or son, parent, brother or sister
- •having ability to understand the content of educational material
排除标准
- •serious comorbidity(stroke, heart attack, acute or chronic respiratory, acute or chronic renal disease, or cancer)
- •inability to speak, hear or read Korean
- •mentally incompetence (schizophrenia, bipolar, psychiatric or addictive disorder, or severe emotional distress)
- •Pregnancy
结局指标
主要结局
Decisional conflict & satisfaction: Decisional Conflict Scale
时间窗: baseline, 1month, 3month, 6month
次要结局
- Quality of Life: Quality Care Questionnaire-End of Life(QCQ-EOL), Korean version of the Caregiver Quality of Life Index - Cancer(CQOLC-K)(baseline, 1month, 3month, 6month)