A Communication-based Intervention for Advanced Cancer Patient-caregiver Dyads to Increase Engagement in Advance Care Planning and Reduce Caregiver Burden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Prognostic Understanding
研究概览
简要总结
The purpose of this study is to: (1) develop a communication-based intervention to improve advanced cancer patients' and caregivers' prognostic understanding using communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention among advanced cancer patients and their caregivers; and (3) test the preliminary efficacy of the intervention on patients' and caregivers' prognostic understanding (primary outcome); completion of DNR order, living will, and health care proxy; psychological distress; communication quality; caregiver burden; and healthcare utilization (secondary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy.
- •Ability to provide informed consent
- •Identification of an informal caregiver
- •Oncologist reported discussion of prognosis with the patient and/or caregiver.
排除标准
- •Not fluent in English
- •Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)
- •Too ill or weak to complete the interviews (as judged by the interviewer)
- •Currently receiving palliative care/hospice at the time of enrollment
- •Children and young adults under age 18
- •Deemed inappropriate for the study by their treating oncologist.
- •In addition, patient-caregiver dyads in which both members have an accurate understanding of prognosis (terminal status and life-expectancy) will be excluded due to the lack of need for an intervention.
- •Caregiver inclusion criteria:
- •The person (family member or friend) whom the patient indicates provides their informal (unpaid) care
- •English speaking
- •Able to provide informed consent
结局指标
主要结局
Change in Prognostic Understanding
时间窗: Baseline, post-intervention (within 30 days)
Change in prognostic understanding is assessed at baseline and post-intervention with two items on prognostic understanding: (1) Terminal illness acknowledgement with the item "How would you describe your current health status?" Answer choices include: 1) Relatively healthy, 2) relatively healthy but terminally ill, 3) seriously ill but not terminally ill, and 4) seriously ill and terminally ill, and (5) I don't know\]. Responses 2 and 4 are coded as accurate and responses 1, 3, and 5 are coded as inaccurate. (2) Life-expectancy \[Months, Years, and "I don't know"\]. Months are coded as accurate and years and I don't know are coded as inaccurate. Each variable is coded as 0=inaccurate or 1=accurate, for a total summary score range of 0 to 2. Differences between baseline and post-intervention assessments are calculated (possible range, -2 to +2) to determine changes in prognostic understanding.
次要结局
- Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention(Baseline, post-intervention (within 30 days))
- Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to 3-month Follow-up(Baseline, follow-up (3 months))
- Change in Communication Quality, as Measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF)(Baseline, post-intervention (within 30 days))
- Change in Caregiver Burden (Caregivers Only), as Measured by the Zarit Burden Interview(Baseline, post-intervention (within 30 days))
- Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention(Baseline, post-intervention (within 30 days))
- Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up(Baseline, follow-up (3 months))
- Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to Post-Intervention(Baseline, post-intervention (within 30 days))
- Change in the Number of Advance Directives Completed(Baseline, post-intervention (within 30 days))
- Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up(Baseline, follow-up (3 months))
- Change in Psychological Distress, as Measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline, post-intervention (within 30 days))