Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma (EPC-MM+L)

Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma, B-Cell; Multiple Myeloma; B Cell Lymphoma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory; Multiple Myeloma Progression; Multiple Myeloma Stage III; Aggressive Lymphoma
• Intervention / Treatment: Other: Early Palliative Care

Detailed Description

In this study, the investigators will test an early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) in a randomized phase II trial in which outpatients and their caregivers will be allocated to one of two groups: symptom screening alone (usual care) or early palliative care alongside usual care (intervention).

Participants will be recruited from multiple myeloma and lymphoma outpatient clinics at the Princess Margaret Cancer Centre. Consenting patients and caregivers will complete questionnaires measuring outcomes of quality of life, symptom burden, depression, and satisfaction with care at recruitment, 1 month, 2 months, and 3 months. After the 3-month follow-up time point, select patients and caregivers will complete a one-time semi-structured interview that explores their experiences taking part in the study. Select healthcare providers from the multiple myeloma, lymphoma, and palliative care teams will also be invited to participate in a one-time focus group or individual interview. Healthcare providers in malignant hematology will be asked to describe their perceptions of palliative care and providers in palliative care will be asked to describe their experiences providing palliative care to patients with multiple myeloma and aggressive lymphoma and their caregivers.

The purposes of this phase II trial are to:

1. Assess the feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only).
2. Assess preliminary efficacy of early palliative care for these outpatients and caregivers.
3. Qualitatively compare patient and caregiver experiences and perceptions of palliative care between the intervention and usual care arms of the study.
4. Qualitatively describe perceptions of palliative care among healthcare providers in malignant hematology, as well as the experiences of providing palliative care to patients with multiple myeloma and aggressive lymphoma among healthcare providers in palliative care.

Feasibility criteria are: (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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Breffni Hannon, MB BCh BAO, MMedSci, MCFP; Phone Number: 3261 416-946-4501; Email: Breffni.Hannon@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Princess Margaret Cancer Centre
      • Contact: Breffni Hannon, MB BCh BAO, MMedSci, MCFP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Palliative Care; 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; see previous description
No Intervention: Usual Care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month and 2 months after enrollment
Patient symptom control as measured by the ESAS-r-CS	The ESAS-r-CS (Edmonton Symptom Assessment System-revised plus constipation and trouble sleeping) consists of 11 scales with anchors of 0 (best) and 10 (worst) with symptom descriptions for pain, fatigue, drowsiness, nausea, anxiety, depression, appetite, dyspnea, well-being. Individual symptom scores are summed for the ESAS Distress Score (9-items) and Total Distress Score (11-items). Individual scores range from 0-10, with lower scores indicating better symptom control.	1 month, 2 months, and 3 months after enrollment
Patient and caregiver depression as measured by the PHQ-9	The PHQ-9 (Patient Health Questionnaire-9 item version) is a measure for screening, diagnosing, and monitoring the severity of depression. Total scores range from 0-27, with higher scores indicating worse depression.	1 month, 2 months, and 3 months after enrollment
Patient satisfaction with care as measured by the FAMCARE-P16	The FAMCARE-P16 (FAMCARE satisfaction with care scale-16-item patient version) is a 16-item scale that measures patient satisfaction with information-giving, availability of care, psychological care and physical patient care in patients with advanced cancer. Total scores range from 16-80, with higher scores indicating greater satisfaction with care.	1 month, 2 months, and 3 months after enrollment
Patient performance status as measured by the PRFS	The PRFS (Patient-Reported Function Status) measures a patient's own activities and function on a five-point scale. It is based on the ECOG (Eastern Cooperative Oncology Group) performance scale, but is expressed in lay language. Total scores range from 0-4, with lower scores indicating better performance status.	1 month, 2 months, and 3 months after enrollment
Caregiver quality of life as measured by the CQOLC	The CQOLC (Caregiver Quality of Life Index-Cancer) is a 35-item measure of burden, disruptiveness, adaptation, financial, and additional caregiver concerns. Total scores range from 0-140, with higher scores indicating worse quality of life.	1 month, 2 months, and 3 months after enrollment
Caregiver satisfaction with patient care as measured by the FAMCARE-caregiver	The FAMCARE-caregiver is a 19-item caregiver version of the FAMCARE scale. Total scores range from 20-100, with higher scores indicating greater satisfaction with patient care.	1 month, 2 months, and 3 months after enrollment

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Myeloma Canada; The Leukemia and Lymphoma Society of Canada
• Investigators: Principal Investigator: Breffni Hannon, MB BCh BAO, MMedSci, MCFP, Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; symptom management; multiple myeloma; aggressive lymphoma; early palliative care
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Multiple Myeloma
• Other Study ID Numbers: DeGasperis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No