Early palliative care for patients with multiple myeloma and aggressive lymphoma
Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
This study is testing if early palliative care can improve the quality of life and comfort for people with multiple myeloma and aggressive lymphoma while they receive their usual cancer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06485076 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and preliminary efficacy of an early palliative care intervention for patients diagnosed with multiple myeloma and aggressive B cell lymphoma. Participants will be randomly assigned to receive either standard symptom screening or early palliative care alongside their usual cancer treatment. The study will measure various outcomes, including quality of life, symptom burden, and patient satisfaction, through questionnaires at multiple time points. Additionally, select participants will engage in semi-structured interviews to share their experiences with the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a new diagnosis or progression of multiple myeloma or relapsed/refractory aggressive B cell lymphoma.
Not a fit: Patients who are currently involved with a palliative care team or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and symptom management for patients with multiple myeloma and aggressive lymphoma.
How similar studies have performed: While early palliative care has shown benefits in solid tumors, this approach has not been extensively tested in blood cancers, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient eligibility criteria: Inclusion criteria: (i) Age ≥18 years; (ii) A new diagnosis of multiple myeloma or at progression of disease necessitating a change in treatment plan, or relapsed/refractory aggressive B cell lymphoma after one prior line of therapy; (iii) Eastern Cooperative Oncology Group (ECOG) performance status 0-3; (iv) Willingness to complete symptom screening; and (v) At least one ESAS-r-plus symptom scored at ≥3 at time of recruitment. Exclusion criteria: (i) Insufficient English literacy to complete study procedures; (ii) Hematologist-determined poor cognitive status; (iii) Current palliative care team involvement at PM or elsewhere; and (iv) Not receiving ongoing follow up with malignant hematology team at PM. Caregiver eligibility criteria: Inclusion criteria: (i) Age ≥18 years; (ii) Caregiver of a patient with relapsed B cell lymphoma; and (iii) Willing to attend at least 1 PCC visit with the patient. Exclusion criteria: (i) Insufficient verbal and/or written English literacy to complete study procedures; or (ii) Patient not participating in study. Healthcare provider eligibility criteria: Inclusion criteria: (i) Specialized staff physician, fellow, clinical nurse specialist, or clinic nurse from the outpatient malignant hematology team or palliative care team at PM working clinically with patients with multiple myeloma; and (ii) Working in their clinical area for at least 12 months.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Breffni Hannon, MB BCh BAO, MMedSci, MCFP — Princess Margaret Cancer Centre
- Study coordinator: Breffni Hannon, MB BCh BAO, MMedSci, MCFP
- Email: Breffni.Hannon@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.