Patient-centered, Optimal Integration of Survivorship and Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Feasibility of POISE - enrollment
研究概览
简要总结
The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are
- is POISE feasible to deliver and acceptable to patients
- what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.
详细描述
This research study involves an intervention consisting of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with NSCLC.
The research study procedures include:
- Four 60-minute visits with a trained palliative care clinician
- Questionnaires and an exit interview
- Chart Review
It is expected that about 70 participants currently receiving targeted therapy at Massachusetts General Hospital for lung cancer will take part in this research study: 10 patients in an open pilot study, followed by 60 patients in a randomized controlled trial.
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
- Single (Outcomes Assessor)
盲法说明
Masking of participants and care providers is not possible in this clinical intervention. However, we will mask the outcomes assessor to minimize bias.
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 18 or older
- •MGH Cancer Center patient
- •Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)
- •Receiving targeted therapy
- •Ability to respond in English or Spanish
排除标准
- •Cognitive impairment or serious mental illness that limits ability to provide informed consent
- •Need for urgent palliative care or hospice referral
- •Pregnant women
- •Prisoners
结局指标
主要结局
Feasibility of POISE - enrollment
时间窗: 20 weeks
≥60% enrollment among eligible patientsamong patients in the POISE group
Feasibility of POISE - completion of all sessions among patients in intervention group
时间窗: 20 weeks
≥70% completion of all sessions in the intervention arm
Feasibility of POISE - completion of surveys in both arms
时间窗: 20 weeks
≥70% completion of all surveys in both arms
次要结局
- Acceptability(20 Weeks)
- Self efficacy(20 weeks)
- Documentation of Goals and Values(20 weeks)
- Acceptability(20 Weeks)
- Emotional coping with prognosis and prognostic awareness(20 weeks)
- Self efficacy(20 weeks)
- Documentation of Goals and Values(20 weeks)
研究者
Laura Petrillo, M.D.
Principal Investigator
Massachusetts General Hospital