Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Completion of advance directives
研究概览
简要总结
The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.
详细描述
Patients with advanced cancer have not fully benefited from advance care planning due to the high levels of anxiety and depression experienced and other barriers that affect their appraisals and coping. Despite the protective effects of resilience, there have been few clinical trials improving the resilience skills of patients with advanced cancer and their family caregivers to help initiate advance care planning discussions and sustain engagement. This research evaluates the impact of a web-based resilience-building intervention called ROCKS on enhancing the completion of advance directives, as well as improving resilience, coping, anxiety, and depression among patients with advanced cancer and their family caregivers.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients will (1) be ≥ 18 years of age; (2) be diagnosed with stage 3 or 4 cancer; and (3) have a family caregiver who is willing to participate.
- •Eligible family caregivers will be ≥ 18 years of age. All participants must be able to read, write, and speak English with minimal assistance from others and have access to the internet on a smartphone, laptop, or computer.
排除标准
- •Patient participants will be ineligible if they have (1) a Short Portable Mental Status Questionnaire (SPMSQ) score < 8; or (2) have completed any form of advance directive.
研究组 & 干预措施
ROCKS
Participants assigned to this arm will receive a web-based resilience-building intervention.
干预措施: ROCKS (Behavioral)
Usual Care
Participants assigned to this arm will receive an advance directive called Five Wishes.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Completion of advance directives
时间窗: Week 8
Completion of Five Wishes
次要结局
- Knowledge(Week 8)
- Self-efficacy(Week 8)
- Anxiety(Week 8)
- Depression(Week 8)
- Resilience(Week 8)
- Optimism(Week 8)
- Dyadic communication and coping(Week 8)