Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma

Not Applicable

Recruiting

• Conditions: Multiple Myeloma in Relapse; Aggressive Lymphoma; Multiple Myeloma Stage III; Multiple Myeloma Progression; Multiple Myeloma; Multiple Myeloma, Refractory; B Cell Lymphoma; Lymphoma, B-Cell
• Interventions: Other: Early Palliative Care

• Registration Number: NCT06485076
• Lead Sponsor: University Health Network, Toronto

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 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

* To see if this early palliative care intervention works well for these patients

* To compare patient experiences with early palliative care and usual care.

Participants 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 symptom burden, mood, quality of life, and satisfaction with care throughout the study. Some participants will also be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in 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. The researchers will use the results of this study to guide in the development of a larger clinical trial.

Detailed Description

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

Participants will be recruited from multiple myeloma and lymphoma outpatient clinics at the Princess Margaret Cancer Centre. Consenting participants 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 participants will complete a one-time semi-structured interview that explores their experiences taking part in the study.

The purpose of this phase II trial is to assess the feasibility and preliminary efficacy of early palliative care for outpatients with multiple myeloma and aggressive lymphoma. Feasibility criteria are: (i) accrual of at least 80 patients over 12 months; (ii) ≥60% complete patient-reported outcomes (PROs) at baseline, 1 month, 2 months, and 3 months; and (iii) in the early palliative care group, ≥60% of patients have at least one visit to the palliative care clinic.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-07-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age ≥18 years;
• a new diagnosis of multiple myeloma or at time of progression of disease necessitating a change in treatment plan, or relapsed/refractory aggressive B cell lymphomas after one prior line of therapy;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-3; and
• willingness to complete symptom screening.

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Exclusion Criteria

• insufficient English literacy to complete study procedures;
• hematologist-determined poor cognitive status;
• current palliative care team involvement at Princess Margaret Cancer Centre or elsewhere;
• referred to the Princess Margaret Cancer Centre for once-off a second opinion and not receiving ongoing follow up with hematology team at the Princess Margaret Cancer Centre; and
• failure to score a single item at ≥3 of the ESAS-r-plus at time of recruitment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Palliative Care	Early Palliative Care	Participants 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 1 week of referral and monthly follow-up visit 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.

Primary Outcome Measures

Name	Time	Method
Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma	12 months	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) over 12 months; (ii) ≥60% complete patient-reported outcomes (PROs) at baseline, and monthly for 3 months; and (iii) in the early palliative care group, ≥60% of patients have at least one visit to the palliative care clinic.
Quality of Life as measured by the FACIT-Pal	3 months after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with care as measured by the FAMCARE-P16	1 month, 2 months, and 3 months after enrollment	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. Scores range from 16-80, with higher scores indicating greater patient satisfaction with care.
Symptom control as measured by the ESAS-r-CS	1 month, 2 months, and 3 months after enrollment	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.
Performance status as measured by the PRFS	1 month, 2 months, and 3 months after enrollment	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. Scores range from 0-4, with lower scores indicating better performance status.
Depression as measured by the PHQ-9	1 month, 2 months, and 3 months after enrollment	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.
Quality of Life as measured by the FACIT-Pal	1 month and 2 months after enrollment	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.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Canada