Actively Recruiting
Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
Led by University Health Network, Toronto · Updated on 2025-12-03
144
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
M
Myeloma Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate an early palliative care approach for patients with multiple myeloma and aggressive B cell lymphoma, as well as caregivers of lymphoma patients. The study addresses the need for better symptom management and quality of life improvements since these patients often face significant physical and psychological challenges. Early palliative care has shown benefits in solid tumor cancers, but its effects on blood cancers have not yet been explored extensively. Participants will be randomly assigned to two groups. One group will receive early palliative care plus usual care from their blood cancer doctor, including an initial comprehensive assessment by a palliative care nurse and physician, and monthly follow-up visits for three months, which may be in-person or virtual. Caregivers are encouraged to attend at least one palliative care visit. The other group will receive usual care alone, with palliative care referrals made at the hematologist’s discretion or upon patient request. Throughout the study, patients and caregivers will complete questionnaires measuring quality of life, symptom burden, mood, and satisfaction with care at baseline and monthly for three months. Select participants and healthcare providers will be interviewed about their experiences. Researchers will review these measures to assess feasibility, preliminary benefits, and perceptions of early palliative care. The total study duration includes 12 months for recruitment and a 3-month follow-up period for each participant.
CONDITIONS
Brief Title
Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- New diagnosis of multiple myeloma or progression requiring treatment change, or relapsed/refractory aggressive B cell lymphoma after one prior therapy
- ECOG performance status between 0 and 3
- Willingness to complete symptom screening
- At least one symptom scored 3 or higher on ESAS-r-plus at recruitment
You will not qualify if you...
- Insufficient English literacy to complete study procedures
- Poor cognitive status as determined by hematologist
- Current involvement with palliative care team at the study center or elsewhere
- Not receiving ongoing follow-up with malignant hematology team at the study center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 3 months
Participants in the intervention group receive early palliative care alongside usual care. This includes a comprehensive interdisciplinary assessment by a specialist palliative care nurse and physician within two weeks of referral, with monthly follow-up visits assessing physical symptoms, psychological distress, social supports, and advance care planning. Caregivers are encouraged to attend at least one visit.
1 initial consultation and monthly follow-up visits for 3 months (in-person, via Microsoft Teams, or phone)
Duration - 3 months
Participants in the usual care group continue their care with their hematologist, with referral to palliative care at the hematologist's discretion or upon patient request.
As per usual care schedule determined by hematologist
Duration - 3 months
Participants and caregivers complete questionnaires measuring quality of life, symptom burden, depression, and satisfaction with care at recruitment and monthly for three months.
4 questionnaire completions (baseline, 1 month, 2 months, 3 months)
Duration - One-time after 3-month follow-up
Select patients, caregivers, and healthcare providers participate in one-time semi-structured interviews or focus groups exploring experiences and perceptions of palliative care.
1 interview or focus group session
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Actively Recruiting
Research Team
B
Breffni Hannon, MB BCh BAO, MMedSci, MCFP
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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