Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility)
研究概览
简要总结
The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups.
The names of the study intervention groups involved in this study are:
- Palliative care (PEACE) plus usual oncology care
- Usual care (standard oncology care)
Participation in this research study is expected to last for up to 2 years.
It is expected that about 90 people will take part in this research study.
详细描述
This is a single-center, parallel-group, randomized controlled study to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT).
10 participants with planned ACT will be enrolled into an open pilot and will receive a palliative care intervention (PEACE) for the duration of treatment. Once the palliative care intervention has been refined by feedback from the pilot participants, the study will enroll 80 participants and will randomly assign the participants into one of two study intervention groups. Randomization means that a participant is put into a group by chance.
The names of the study intervention groups involved in this study are:
- Palliative care intervention (PEACE) plus usual oncology care
- Usual care (standard oncology care)
Participation in this research study is expected to last for up to 2 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Ability to complete surveys in English or with assistance of an interpreter.
- •Diagnosis of a hematologic malignancy.
- •Receiving autologous adoptive cellular therapy (ACT) at MGH with an FDA approved cellular therapy product.
排除标准
- •Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment.
- •Already receiving palliative care (PC).
研究组 & 干预措施
Palliative Care Intervention (PEACE) Group
Participants will be randomly assigned, and stratified by disease, to the PEACE Group.
- Participants will meet with palliative care (PC) clinician within 1 week of T-cell collection and within 72 hours of hospital admission for ACT.
- Participants will meet with PC clinician at least 2 x weekly during hospitalization.
- PC clinician will follow participants up to one year after randomization (or enrollment for the open pilot) and will meet participant at least 2 x weekly during inpatient hospitalizations.
- Participants will complete follow-up study assessments on pre-determined days per protocol. The assessments will be filled out remotely or via paper.
- Participants will complete exit interviews in the open pilot only.
干预措施: Palliative Care (Behavioral)
Usual Care Group
Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility)
时间窗: 1 day
Defined as at least 60% of eligible participants enrolling in the study, and among those enrolled and randomized to PEACE, 80% receiving PEACE as intended.
次要结局
- Quality of Life - FACT-G(Baseline to day 90)
- Prognostic Understanding(Baseline to day 90)
- End-of-Life Communication(Baseline to day 90)
- Acceptability(Up to Day 90)
- Post-Traumatic Stress Disorder (PTSD) Symptoms(Baseline to day 90)
- Depression Symptoms(Baseline to day 90)
- Physical Symptom Burden(Baseline to day 90)
- Anxiety Symptoms(Baseline to day 90)
- Coping(Baseline to day 90)
研究者
Patrick C. Johnson, MD
Principal Investigator
Massachusetts General Hospital