A Pilot Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- DLR Intervention Enrollment Rate
研究概览
简要总结
The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work.
详细描述
The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work. The study will enroll dyads (pairs) of caregivers and older patients with advanced cancer and dyads of caregivers and patients with advanced cancer. A previous single-arm study was performed testing the feasibility of the adapted DLR intervention in older adults with advanced cancer and their caregivers. The single-arm pilot demonstrated DLR was feasible and acceptable by both patients and caregivers. This innovative pilot study will gather data to test the feasibility of a pilot and examine pre-post intervention changes in caregiver psychological distress.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Patient has a Stage III or IV advanced cancer diagnosis of any type
- •Score of 4 or more on National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT)*
- •Able to read and understand English
排除标准
- •Unable to identify caregiver to participate in study
- •Caregiver Inclusion Criteria:
- •One caregiver must enroll with each patient for either subject to be eligible.
- •Caregivers will be selected by the patient when asked if there is a "significant other, spouse, romantic partner, or adult child with whom you discuss or can be helpful in health-related matters;"
- •Age 50 or older
- •Able to reach and understand English
- •Caregiver Exclusion Criteria:
- •Caregivers unable to provide consent
研究组 & 干预措施
Dyadic Life Review
The Dyadic Life Review Arm (DLR) consists of 8 sessions delivered by a trained licensed clinician. Each session facilitates a recall of each phase of life. The patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life. Interventionists are able to use clinical judgment to prompt further or ask follow-up questions or reflections. Additionally, the patient and caregiver will be asked to respond to the other dyad member's memory or reflection. Each session will have flexibility for clinical judgement.
干预措施: Dyadic Life Review (Behavioral)
Case-As-Usual
The Care-As-Usual (CAU) arm will follow current practices for responding to patient distress. The CAU for patients involves a supportive follow-up phone call from the social work team to further assess the patient's experience of distress. In some instances, the social worker will use their clinical judgement to further refer the patient to community resources to support distress. The number of phone calls and any subsequent community referrals or appointments related to distress that occur will be tracked.
结局指标
主要结局
DLR Intervention Enrollment Rate
时间窗: 18 weeks
Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate.
DLR Intervention Retention Rate
时间窗: 18 weeks
Evaluate the feasibility of DLR in older patients and caregivers based on retention rate.
次要结局
- Unidimensional Relationship Closeness Scale(18 weeks)
- Distress Thermometer(18 weeks)
- Communication Satisfaction Scale(18 weeks)
研究者
Lee Kehoe
PhD
University of Rochester