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/27893130Actively Recruiting
Led by Alberta Health Services, Calgary · Updated on 2024-07-31
152
Participants Needed
1
Research Sites
33 weeks
Total Duration
A
Alberta Health Services, Calgary
Lead Sponsor
A
Alberta Cancer Foundation
Collaborating Sponsor
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
Early Integration of Palliative and Supportive Care in Cellular Therapy
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
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
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
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
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
Total: 1 location
1
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Actively Recruiting
R
Reanne Booker, PhD(c)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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