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.
Patients
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
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
Patients
Patients undergoing HSCT for a non-malignant hematologic condition
Inability to provide informed consent
Parallel
Early palliative and supportive care
Other interventionThe intervention itself will be predominantly the provision of education and information. It is possible that patients in the intervention arm may receive treatment recommendations to help manage symptoms.
Patient quality of life
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.
Patient symptom burden
The Edmonton Symptom Assessment System (ESAS) is a validated scale that assesses symptom burden in patients with cancer. While several iterations of the ESAS are available, this study will use the ESAS-revised (ESAS-r) which includes 10 items scored using a numeric rating scale, where 0=no symptom and 10=worst symptom. The ESAS assesses physical symptoms (pain, fatigue, nausea, drowsiness, dyspnea, loss of appetite), emotional symptoms (anxiety and depression), and well-being. Individual patient scores will be tracked over time to assess the trajectory of symptom burden.
Patient and family caregiver prognostic understanding
The Perception of Treatment and Prognosis Questionnaire (PTPQ) is 10 item self-report questionnaire that assesses patients' beliefs about the likelihood of cure, the importance and helpfulness of knowing about prognosis, the primary goal of cancer treatment, the preferences for information about treatment, and the satisfaction with quality of information provided regarding prognosis and treatment. Items on the questionnaire are scored individually with statements about the degree to which the patient agrees with each item. Patients and CGs will complete the PTPQ pre-HSCT/CAR T-cell therapy and at 3 months post HSCT/CAR T-cell therapy.
Family caregiver quality of life
The Quality of Life in Life-Threatening Illness - Family carer version 2 (QOLLTI-F v2) will be used to assess CG QOL. The QOLLTI-Fv2 is a 17-item questionnaire that includes seven subscales that assess the following domains: environment, patient condition, the CG's own state, quality of care, relationships, and financial worries. In addition, there is a single item that pertains to overall QOL. Items on the QOLLTI-Fv2 are ranked from 0-10 (total possible score ranges from 0-170), where higher scores are associated with better QOL. Caregivers in both the intervention and standard care arms will complete the QOLLTI-Fv2 pre-HSCT/CAR T-cell therapy, and at 2-weeks, 1-month, and 3-months post-HSCT/CAR T-cell therapy.
1 year overall survival
Patient survival at 1 year post-study enrolment
5 year overall survival
Patient survival at 5 years post-study enrolment
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Alberta Health Services, Calgary
Lead sponsor
Alberta Cancer Foundation
Collaborator
University of Victoria
Collaborator
