Recruiting

Palliative Care

Sponsor:

University Health Network, Toronto

Code:

NCT06485076

Conditions

Multiple Myeloma in Relapse

Multiple Myeloma, Refractory

Multiple Myeloma Stage III

Multiple Myeloma Progression

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Early Palliative Care

Study Details

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 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.

Conditions

Multiple Myeloma in Relapse

Multiple Myeloma, Refractory

Multiple Myeloma Stage III

Multiple Myeloma Progression

Multiple Myeloma

Study ID

NCT06485076

Start date

Jul 18, 2024

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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

Interventions

Early Palliative Care

see previous description

Primary outcome measure

  • Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only) [ Time Frame: 12 months ]
  • Patient quality of life as measured by the FACIT-Pal [ Time Frame: 3 months after enrollment ]

Central Contacts and Locations

Central contacts

Breffni Hannon, MB BCh BAO, MMedSci, MCFP

416-946-4501Breffni.Hannon@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Keywords

  • early palliative care
  • multiple myeloma
  • quality of life
  • symptom management
  • aggressive lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-03.