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Behavioural Intervention

Early Palliative Care for Multiple Myeloma and Lymphoma

N/A

Recruiting

Led By Breffni Hannon, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-3

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the effectiveness of providing early palliative care alongside usual cancer care for patients with multiple myeloma and aggressive B cell lymphoma. Patients will be split into two groups: one

Who is the study for?

This trial is for patients with multiple myeloma or aggressive B-cell lymphoma. It's designed to see if early palliative care, alongside standard cancer treatment, can improve their well-being and quality of life.

What is being tested?

The study tests whether introducing early palliative care improves outcomes like symptom management and mood compared to usual cancer care alone. Participants are randomly assigned to receive either additional early palliative care or just the standard treatment.

What are the potential side effects?

Since this trial focuses on palliative care (comfort measures), it does not involve new medications; therefore, typical drug side effects are not a concern here. The impact will be more on emotional and psychological aspects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may not be able to do heavy physical work.

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I have a new or worsening multiple myeloma or aggressive B cell lymphoma after one treatment.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 2 months, and 3 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 2 months, and 3 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 2 months, and 3 months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma

Quality of Life as measured by the FACIT-Pal

Secondary study objectives

Depression as measured by the PHQ-9

Performance status as measured by the PRFS

Satisfaction with care as measured by the FAMCARE-P16

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early Palliative CareExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

Participants 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

0 / 3Eligibility criteria met