Early Integration of Palliative and Supportive Care for Patients and Family Caregivers Undergoing Hematopoietic Stem Cell Transplantation or Chimeric Antigen Receptor T-Cell Therapy: A Prospective Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Patient quality of life
研究概览
简要总结
Research has shown that early palliative care in cancer care is associated with improved symptom management, better prognostic understanding, improved quality of life for patients and family caregivers, and even improved survival. Yet, in spite of the proven benefits of integration of palliative care in oncology, it has been well established that patients with hematologic malignancies and those undergoing cellular therapy (hematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor (CAR) T-cell therapy) do not routinely receive palliative care. Most of the published research on the early integration of palliative care in oncology describes studies that have involved patients with solid tumours. To date, only one randomized trial examining the impact of integrated palliative care among patients undergoing HSCT has been published and there have been no studies examining the impact of integrated palliative care for patients undergoing CAR T-cell therapy. The American Society of Clinical Oncology recommends early palliative care for patients with advanced cancers or for those with high symptom burden. Patients with blood cancers experience high symptom burden and in the last 30 days of life, compared to patients with solid tumours, patients with blood cancers are more likely to die in hospital, have more intensive care unit admissions, have prolonged hospitalizations (>14 days), and pass away in an acute care facility. There is an urgent need to proactively address suffering throughout cellular therapy trajectories, even before treatment starts, so that patients and caregivers are not inevitably waiting for symptoms to arise before they can be addressed and to optimize quality of life for patients undergoing transplant as well as their family caregivers.
PALS_CT will compare early palliative care to standard care for patients and their family caregivers undergoing HSCT or CAR T-cell therapy for blood cancers.
详细描述
Problem: patients undergoing HSCT and CAR T-cell therapy experience high symptom burden (physical, psychological, spiritual), lack illness and prognostic understanding (which can adversely impact medical decision making). Research has found that patients with blood cancers experience poor end-of-life (EOL) quality indicators such as disease-directed therapy in the weeks before death, emergency room visits in the weeks before death, intensive care unit (ICU) admissions near the EOL, low rates of hospice use, and dying in hospital. Family caregivers (CGs) of patients undergoing HSCT and CAR T-cell therapy experience impaired QOL, physical and psychosocial concerns, and have expressed that their needs have not been adequately addressed by care teams. Palliative care, with its multidisciplinary approach and focus on improving QOL from a holistic perspective, can help reduce symptom burden and improve QOL, improve illness and prognostic understanding, and improve EOL care for patients undergoing HSCT and CAR T-cell therapy and their family CGs. This trial will assess the effectiveness of early PC in improving QOL for patients and their family CGs undergoing HSCT or CAR T-cell therapy for hematological malignancies.
Objectives The objectives for this study were developed after extensive review of the literature as well as were informed by preliminary data derived from an ongoing qualitative study that sought the perspectives of patients, family CGs, and clinicians regarding the integration of PC in HSCT.
Objective 1: To examine the impact of an outpatient PC intervention on patient-reported QOL for patients undergoing HSCT or CAR T-cell therapy Hypothesis: patients randomized to the PC intervention will report greater improvement in QOL at 1-month post-HSCT/CAR T-cell therapy and at 3 months post-HSCT/CAR T-cell therapy compared to patients receiving standard care.
Objective 2: To examine the impact of an outpatient PC intervention on symptoms at 2 weeks, 1 month, and 3 months post-HSCT/CAR T-cell therapy for patients undergoing HSCT/CAR T-cell therapy Hypothesis: patients randomized to the PC intervention will report a greater reduction in physical symptoms at 2 weeks, 1 month, and 3 months post-HSCT/CAR T-cell therapy compared to patients receiving standard care
Objective 3: To examine the impact of an outpatient PC intervention on family CG QOL at 1 month and 3 months post-HSCT/CAR T-cell therapy for CGs of patients undergoing HSCT/CAR T-cell therapy Hypothesis: family CGs of patients randomized to the PC intervention will report greater improvement in QOL compared to family CGs of patients receiving standard care
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
It will not be possible to blind participants or researchers (PC clinicians who will be involved in delivery the intervention) to the intervention but the individual doing the data collection, the research assistant, will be blinded to the randomization allocation.
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
- •Clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy
- •Ability to speak, read, and understand English or, be able to complete questionnaires with minimal assistance required from an interpreter
- •Inclusion Criteria - Family Caregivers
- •Family caregivers of patients with a clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy
- •A spouse, relative, or friend, identified by the patient, who either lives with the patient or has in-person contact with the patient at least twice per week. Only one family CG per patient will be asked to participate.
- •Ability to speak, read, and understand English or willing to complete questionnaires with minimal assistance required from an interpreter
排除标准
- •Patients undergoing HSCT for a non-malignant hematologic condition
- •Inability to provide informed consent
- •Exclusion Criterion - Family Caregivers
- •* Inability to provide informed consent
结局指标
主要结局
Patient quality of life
时间窗: 3 months
The primary outcome of the study, QOL, will be assessed using the McGill Quality of Life Questionnaire - Expanded (MQOL-E) summary score of QOL monthly for a period of three months. The MQOL-E consists of 21 items with possible scores of 0 to 10 for each item. The higher the score, the better the QOL. The trajectories of QOL will be evaluated rather than looking at change in scores as it is anticipated that there will be significant fluctuation in QOL scores over time. The Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) will also be used to measure QOL. The FACT-BMT is more specific to BMT and may capture issues that are unique to BMT. The FACT-BMT consists of 47 items; a 5-point Likert-type scale is used for item. The total score ranges from 0-196 and higher scores indicate better QOL.
次要结局
- Family caregiver quality of life(3 months)
- Patient symptom burden(3 months)
- Patient and family caregiver prognostic understanding(3 months)
研究者
Reanne Booker
Principal Investigator
Alberta Health Services, Calgary