Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma

NCT06485076 | Recruiting DMC

• 1 other identifier: DeGasperis
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis. Meanwhile, patients with aggressive lymphomas undergo unpredictable illness courses, resulting in goals of care conversations occurring late in the illness trajectory and aggressive care being received in the last 30 days of life. Early palliative care alongside usual cancer care has been shown to improve patient outcomes such as symptom burden, mood, and quality of life in patients with solid tumours (e.g. lung, breast or gynecological cancers), but has not been explored among patients with blood cancers to date. The goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) attending the Princess Margaret Cancer Centre. The main goals of the study are:

• To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only)
• To see if this early palliative care intervention works well for these patients and caregivers
• To compare patient and caregiver experiences with early palliative care and usual care
• To explore perceptions and experiences of providing palliative care among healthcare providers involved in the care of these patients and caregivers. Patients, and their respective caregivers if participating, will be randomly assigned to one of two groups: one group will receive early palliative care in addition to usual care from their blood cancer doctor, and the other group will receive usual care from their blood cancer doctor only. All participants will be asked to fill out questionnaires about their quality of life, symptom burden, mood, and satisfaction with care throughout the study. Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care and their caregivers. Some patients and caregivers will be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study. Some healthcare providers who care for these patients will also be asked to take part in interviews at the end of the trial to describe their perceptions and experiences of providing palliative care. The researchers will use the results of this study to guide in the development of a larger clinical trial.

Conditions

Multiple Myeloma, Refractory; Multiple Myeloma Stage III; Multiple Myeloma Progression; Multiple Myeloma; B Cell Lymphoma; Lymphoma, B-Cell; Aggressive Lymphoma; Multiple Myeloma in Relapse

Keywords

early palliative care; multiple myeloma; quality of life; symptom management; aggressive lymphoma

Outcome Measures

Primary Outcomes (2)

• Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only)

  The intervention will be feasible if the following criteria are met: (i) accrual of at least 80 patients (40 with multiple myeloma and 40 with aggressive B cell lymphoma) and up to 40 caregivers of patients with aggressive B cell lymphoma over 12 months; (ii) ≥60% of recruited patients and caregivers complete self-reported outcomes (PROs) at baseline, and monthly for three months; and (iii) ≥60% of patients and their caregivers in the intervention arm have at least one visit to the palliative care clinic.

  12 months

• Patient quality of life as measured by the FACIT-Pal

  The FACIT-Pal (Functional Assessment of Chronic Illness Therapy-Palliative Care) quality of life scale is a version of the 27-item FACT-G (Functional Assessment of Cancer Therapy-General) scale, with the addition of 19 items for patients with advanced illness. These 46 items measure physical, social/family, emotional, functional well-being, and additional concerns. Total scores range from 0-184, with higher scores indicating better quality of life.

  3 months after enrollment

Secondary Outcomes (7)

• Patient quality of life as measured by the FACIT-Pal

  1 month and 2 months after enrollment

• Patient symptom control as measured by the ESAS-r-CS

  1 month, 2 months, and 3 months after enrollment

• Patient and caregiver depression as measured by the PHQ-9

  1 month, 2 months, and 3 months after enrollment

• Patient satisfaction with care as measured by the FAMCARE-P16

  1 month, 2 months, and 3 months after enrollment

• Patient performance status as measured by the PRFS

  1 month, 2 months, and 3 months after enrollment

Study Arms (2)

Early Palliative Care

EXPERIMENTAL

Patients in the intervention/early palliative care arm will be invited to attend a consultation (in-person or via Microsoft Teams) in the outpatient palliative care clinic alongside ongoing care from their hematologist. The intervention will comprise of a comprehensive interdisciplinary assessment from a specialist palliative care nurse and a physician within two weeks of referral and monthly follow-up visits (in-person, via Microsoft Teams, or via phone) for 3 months. This will include an assessment of physical symptoms, psychological distress, social supports and advance care planning, as well as 24/7 telephone support between visits, community-based resources, and access to the acute palliative care unit, if required. Caregivers of these patients will be encouraged to attend at least one palliative care clinic visit with the patient.

Other: Early Palliative Care

Usual Care

NO INTERVENTION

Patients in the usual care arm will receive care from their hematologist as usual, with referral to the outpatient palliative care clinic at the discretion of the hematologist or upon patient request

Interventions

Early Palliative Care OTHER

see previous description

Early Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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:
• (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.
• (i) Insufficient verbal and/or written English literacy to complete study procedures; or (ii) Patient not participating in study.
• Healthcare provider eligibility 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.

Sponsors & Collaborators

• The Leukemia and Lymphoma Society of Canada: collaborator
• Myeloma Canada: collaborator
• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphatic Diseases

Study Officials

• Breffni Hannon, MB BCh BAO, MMedSci, MCFP

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breffni Hannon, MB BCh BAO, MMedSci, MCFP

CONTACT

416-946-4501; Breffni.Hannon@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: July 3, 2024
• Study Start: July 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)