Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05190653

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

Led by Alberta Health Services, Calgary · Updated on 2024-07-31

152

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

Sponsors

A

Alberta Health Services, Calgary

Lead Sponsor

A

Alberta Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the early integration of palliative and supportive care for patients undergoing hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T-cell therapy for blood cancers. Patients with these conditions face high symptom burdens and often experience poor end-of-life outcomes compared to those with solid tumors. The study also focuses on the quality of life for family caregivers, recognizing their physical and psychosocial challenges. Participants will be randomly assigned to receive either early outpatient palliative care or standard care. The palliative care intervention includes education and support delivered by a nurse practitioner or physician, focusing on symptom management, advance care planning, prognostic understanding, and coping strategies. Meetings occur one to two times weekly from before treatment until three months after HSCT or CAR T-cell therapy. Standard care follows usual procedures, with palliative care consultations as needed. During the study, patients and caregivers will complete questionnaires at baseline, at specific times shortly after treatment, and at one and three months post-treatment. Data will be collected remotely via secure electronic surveys. Researchers will assess patient quality of life, symptom burden, and understanding of prognosis, as well as caregiver quality of life. Medical records may be accessed for up to five years to gather treatment and disease information. The total participation duration includes follow-up evaluations up to three months post-treatment, with optional longer-term questionnaire completion.

CONDITIONS

Brief Title

Early Integration of Palliative and Supportive Care in Cellular Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a clinical diagnosis of blood cancer scheduled for hematopoietic stem cell transplantation or CAR T-cell therapy
  • Ability to speak, read, and understand English or complete questionnaires with minimal interpreter assistance
  • Family caregivers who are spouses, relatives, or friends identified by the patient
  • Family caregivers who live with the patient or have in-person contact at least twice per week
  • Family caregivers able to speak, read, and understand English or complete questionnaires with minimal interpreter assistance
Not Eligible

You will not qualify if you...

  • Patients undergoing transplantation for non-malignant blood conditions
  • Inability of patients to provide informed consent
  • Inability of family caregivers to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Outpatient Palliative and Supportive Care Intervention

Duration - From pre-transplant/CAR T-cell therapy to 3 months post-treatment

Participants randomized to the intervention arm will meet with a palliative care nurse practitioner or physician via phone or Zoom. The first meeting occurs before transplant or CAR T-cell therapy to provide education on palliative care, symptom management, advance care planning, and coping strategies. Subsequent meetings occur 1 to 2 times weekly until 3 months post-treatment to support symptom management and illness understanding.

Weekly visits 1 to 2 times per week until 3 months post-treatment

Standard Care Observation

Duration - From treatment initiation to 3 months post-treatment

Participants receiving standard care will undergo usual treatment for HSCT or CAR T-cell therapy, which may include palliative care consultations as needed or upon request.

Follow usual care schedule; no additional study visits required

Post-Treatment Questionnaire Assessments

Duration - Up to 3 months post-treatment with optional assessments at 6 to 12 months

Participants and their family caregivers complete questionnaires remotely via email at specific time points to assess quality of life, symptom burden, and prognostic understanding.

Questionnaires completed remotely at 2 weeks, 1 month, 3 months, and optionally 6 to 12 months post-treatment

Long-term Medical Chart Access

Duration - Up to 5 years post-treatment

Patient participants who consent allow researchers to access their medical charts for up to 5 years post-treatment to collect disease and treatment information.

No visits; data collected via medical record review

Trial Site Locations

Total: 1 location

1

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Actively Recruiting

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Research Team

R

Reanne Booker, PhD(c)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial.

Areej El-Jawahri, Thomas LeBlanc, Harry VanDusen...

https://pubmed.ncbi.nlm.nih.gov/27893130

Effects of Early Integrated Palliative Care in Patients With Lung and GI Cancer: A Randomized Clinical Trial.

Jennifer S Temel, Joseph A Greer, Areej El-Jawahri...

https://pubmed.ncbi.nlm.nih.gov/28029308

Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update.

Betty R Ferrell, Jennifer S Temel, Sarah Temin...

https://pubmed.ncbi.nlm.nih.gov/28034065