Recruiting

Palliative Care

Sponsor:

Alberta Health Services, Calgary

Code:

NCT05190653

Conditions

Leukemia

Lymphoma

Multiple Myeloma

Blood Cancer

Stem Cell Transplant Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early palliative and supportive care

Study Details

Brief summary:

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.

Conditions

Leukemia

Lymphoma

Multiple Myeloma

Blood Cancer

Stem Cell Transplant Complications

Study ID

NCT05190653

Start date

Apr 8, 2022

Status verified date

Jul, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Apr 8, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria - 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

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

Exclusion Criteria - Patients

  • Patients undergoing HSCT for a non-malignant hematologic condition
  • Inability to provide informed consent

Exclusion Criterion - Family Caregivers

\* Inability to provide informed consent

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Palliative and Supportive Care Intervention

Participants randomized to the intervention arm will meet (either by phone or Zoom contingent upon participant preference) with a palliative care nurse practitioner or palliative care physician. During the first meeting, pre-transplant/CAR T-cell therapy, content will focus on the provision of information and education, including: a description of palliative and supportive care, symptom management, advance care planning, prognostic and illness understanding and treatment expectations, and coping strategies. All subsequent visits will include, at minimum, these topics. All meetings will be audio-recorded using a handheld audio-recorder; the record feature of Zoom will not be utilized. Participants in the intervention arm will meet with a member of the study team (palliative care nurse practitioner or palliative care physician) one to two times weekly, or more frequently if requested by the patient and/or family caregiver, until 3 months post-transplant/CAR T-cell therapy.

no intervention: Standard Care

Standard care will involve the usual care that patients undergoing HSCT/CAR T-cell therapy would be expected to receive, including palliative care consultation as needed or upon request. Palliative care interventions beyond what are provided in the study will be tracked in both the intervention and the standard care arms.

Interventions

Early palliative and supportive care

The 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.

Primary outcome measure

  • Patient quality of life [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Don Morris, MD PhD

403-521-370

Principal Investigator:

Reanne Booker, PhD(c) MN

More Information

Sponsor

Alberta Health Services, Calgary

Last update posted

Jul 31, 2024

Last verified

Jul, 2024

Keywords

  • palliative care
  • supportive care
  • quality of life
  • symptom burden
  • hematologic malignancies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alberta Health Services, Calgary on 2024-07-31.