Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
NCT Number: NCT06485076
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Myeloma in Relapse|Multiple Myeloma, Refractory|Multiple Myeloma Stage III|Multiple Myeloma Progression|Multiple Myeloma|B Cell Lymphoma|Lymphoma, B-Cell|Aggressive Lymphoma
Interventions: OTHER: Early Palliative Care
Sponsor: University Health Network, Toronto
Collaborators: Myeloma Canada|The Leukemia and Lymphoma Society of Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-18
Completion Date: 2026-06
Locations: Princess Margaret Cancer Centre, Toronto, Canada

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.

Primary Outcome Measures: Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma, 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., 12 months|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: 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|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|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|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. Scores range from 16-80, with higher scores indicating greater patient satisfaction with care., 1 month, 2 months, and 3 months after enrollment|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. Scores range from 0-4, with lower scores indicating better performance status., 1 month, 2 months, and 3 months after enrollment