Clinical trial NCT06485076: Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
Official title: Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: 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
Keywords: early palliative care
multiple myeloma
quality of life
symptom management
aggressive lymphoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Myeloma Canada
name: The Leukemia and Lymphoma Society of Canada
First posted: 2024-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma
timeFrame: 12 months
measure: Quality of Life as measured by the FACIT-Pal
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Quality of Life as measured by the FACIT-Pal
timeFrame: 1 month and 2 months after enrollment
measure: Symptom control as measured by the ESAS-r-CS
timeFrame: 1 month, 2 months, and 3 months after enrollment
measure: Depression as measured by the PHQ-9
timeFrame: 1 month, 2 months, and 3 months after enrollment
measure: Satisfaction with care as measured by the FAMCARE-P16
timeFrame: 1 month, 2 months, and 3 months after enrollment
measure: Performance status as measured by the PRFS
timeFrame: 1 month, 2 months, and 3 months after enrollment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Breffni Hannon, MD
role: PRINCIPAL_INVESTIGATOR
References: