Early Palliative Care for Multiple Myeloma and Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by Breffni Hannon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: Poor English literacy, Poor cognitive status, Current palliative care, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual cancer care, but it's best to confirm with the trial coordinators.

What data supports the effectiveness of the treatment Early Palliative Care, Supportive Care, Palliative Medicine for Multiple Myeloma and Lymphoma?

Research shows that early palliative care can improve the quality of life and reduce symptoms for patients with advanced cancer. It also suggests that early palliative care may help reduce depression and increase survival time. ^{1 2 3 4 5}

Is early palliative care safe for humans?

The research does not provide specific safety data for early palliative care, but it is generally considered safe as it focuses on improving quality of life and managing symptoms rather than aggressive treatments. ^{3 6 7 8 9}

How is early palliative care treatment different for multiple myeloma and lymphoma?

Early palliative care for multiple myeloma and lymphoma focuses on improving quality of life by addressing symptoms and emotional needs earlier in the treatment process, rather than waiting until the end stages of the disease. This approach is unique because it integrates supportive care alongside standard treatments from the beginning, which is not commonly done for these conditions. ^{3 8 10 11 12}

Research Team

Breffni Hannon, MD

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

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.

Inclusion Criteria

Willingness to complete symptom screening

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

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

Exclusion Criteria

Insufficient English literacy to complete study procedures

Failure to score a single item at ≥3 of the ESAS-r-plus at time of recruitment

Hematologist-determined poor cognitive status

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Palliative Care Intervention

Participants receive a comprehensive interdisciplinary assessment and monthly follow-up visits for 3 months, including 24/7 telephone support and access to community-based resources.

3 months

1 initial consultation (in-person or virtual), monthly follow-up visits

Follow-up

Participants are monitored for outcomes such as quality of life, symptom burden, and satisfaction with care.

3 months

Monthly assessments

Treatment Details

Interventions

• Early Palliative Care (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Early Palliative Care Experimental Treatment 1 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 Care Active Control 1 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Myeloma Canada

Collaborator

Trials

2

Recruited

640+

The Leukemia and Lymphoma Society of Canada

Collaborator

Trials

1

Recruited

80+

Findings from Research

The EMPOWER 2 intervention, developed with input from 21 stakeholders and tested with 10 patients, effectively increased knowledge about palliative care by 83.1% and improved attitudes towards it by 18.9 points, indicating its potential to enhance patient readiness for palliative care.

The intervention was highly acceptable to stakeholders (3.78/4.00) and successfully met feasibility criteria, enrolling 10 patients within 14 days with an 83.3% consent rate, suggesting it can be implemented in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Readiness for Early Integrated Palliative Oncology Care: Development and Initial Evaluation of the EMPOWER 2 Intervention. Perry, LM., Sartor, O., Malhotra, S., et al.[2022]

Early palliative care, recommended in international guidelines, significantly improves patients' quality of life and reduces symptom burden, as confirmed by a meta-analysis of seven randomized studies.

There is a trend indicating that early palliative care may also reduce depressive disorders and potentially increase overall survival, while benefiting patients' relatives and decreasing aggressive end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early palliative care in oncology]. Bouleuc, C., Burnod, A., Angellier, E., et al.[2019]

Patients with multiple myeloma receiving early palliative care (EPC) showed significantly better quality of care indicators compared to those receiving usual hematological care (UHC), with an average of 2.62 indicators versus 1.12 (p<0.0001).

EPC patients experienced a significant reduction in pain intensity over time and demonstrated a trend towards less aggressive end-of-life care, while having similar survival rates compared to UHC patients (5.3 vs 5.46 years; p=0.74).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early palliative care versus usual haematological care in multiple myeloma: retrospective cohort study. Giusti, D., Colaci, E., Pioli, V., et al.[2023]

A meta-analysis of 12 randomized controlled trials involving 2980 advanced cancer patients found that early palliative care significantly improves quality of life (QoL) both within 3 months and after 3 months compared to usual care.

Patients receiving early palliative care also experienced a notable reduction in symptom intensity and improved functional well-being, suggesting that this approach offers substantial clinical benefits over standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Early Palliative Care in Advanced Cancer Patients: A Meta-Analysis. Shih, HH., Chang, HJ., Huang, TW.[2022]

Recent studies have shown that high-cutoff hemodialysis can effectively remove free light chains in patients with renal disease related to multiple myeloma, improving their kidney function.

Updated guidelines recommend the use of levofloxacin to prevent infections and suggest effective management strategies for bone disease and anemia, which are crucial for enhancing the quality of life in myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care in Multiple Myeloma. Guzdar, A., Costello, C.[2020]

Among 5095 patients with multiple myeloma analyzed from 2006 to 2018, a significant majority (65.4%) received supportive care at the end of life, indicating a shift towards more compassionate care options.

Despite improvements in supportive care over the years, disparities still exist, with older patients and those from lower-income neighborhoods less likely to receive adequate supportive care, highlighting ongoing challenges in end-of-life treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of end-of-life care in multiple myeloma: A 13-year analysis of a population-based cohort in Ontario, Canada. Mohyuddin, GR., Sinnarajah, A., Gayowsky, A., et al.[2022]

In a study of 119 older patients with multiple myeloma, 63% were hospitalized in their last month of life, and 64% continued to receive aggressive antimyeloma treatments, indicating a high level of intervention even at the end-of-life stage.

Only 20% of patients received palliative care referrals, highlighting a significant gap in support for managing pain and other symptoms, suggesting a need for better collaboration between palliative care teams and hematologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective review of end-of-life care in the last month of life in older patients with multiple myeloma: what collaboration between haematologists and palliative care teams? Chalopin, T., Vallet, N., Benboubker, L., et al.[2020]

Out of 456 deceased multiple myeloma patients studied, only 45.4% received specialist palliative care (SPC) during their illness, indicating low rates of SPC involvement in managing end-of-life care.

There was no significant correlation between receiving outpatient SPC and a reduction in deaths occurring in acute care settings, suggesting that SPC may not have effectively decreased aggressive end-of-life treatments for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care utilization, transfusion burden, and end-of-life care for patients with multiple myeloma. McInturf, G., Younger, K., Sanchez, C., et al.[2022]

Patients and caregivers in a study of early palliative care alongside standard oncology care viewed the roles of oncologists and palliative care physicians as distinct yet complementary, enhancing overall cancer care.

The study suggests that integrating early palliative care into oncology can improve patient experiences by providing holistic symptom management alongside disease-focused treatment, advocating for more ambulatory palliative care clinics and timely referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Palliative Care and Its Role in Oncology: A Qualitative Study. Hannon, B., Swami, N., Pope, A., et al.[2022]

In a study of 238 multiple myeloma patients, researchers identified four distinct health-related quality of life trajectories, with two classes showing stable poor or declining quality of life over an 8-month period.

Key predictors of declining quality of life included high general symptom levels, clinically relevant anxiety, and pain, suggesting that early palliative care should focus on these patient-reported symptoms and psychosocial factors to identify those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms and anxiety predict declining health-related quality of life in multiple myeloma: A prospective, multi-centre longitudinal study. Ramsenthaler, C., Gao, W., Siegert, RJ., et al.[2020]

In a 10-year study of 26 multiple myeloma patients in the Niger-Delta region, most presented with advanced disease (61.5% in stage III) and experienced severe complications like bone pain (84.6%) and anemia (61.5%), highlighting the need for earlier diagnosis and better palliative care.

Only 7.6% of patients survived up to 5 years post-diagnosis, with a mean survival of 39.7 months, indicating that late diagnosis and inadequate palliative interventions significantly contribute to poor outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple myeloma in Niger Delta, Nigeria: complications and the outcome of palliative interventions. Nwabuko, OC., Igbigbi, EE., Chukwuonye, II., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Increasing Readiness for Early Integrated Palliative Oncology Care: Development and Initial Evaluation of the EMPOWER 2 Intervention. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Early palliative care in oncology]. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Early palliative care versus usual haematological care in multiple myeloma: retrospective cohort study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Early Palliative Care to Improve Quality of Life of Advanced Cancer Patients: A Meta-Analysis of Randomised Controlled Trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Early Palliative Care in Advanced Cancer Patients: A Meta-Analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Supportive Care in Multiple Myeloma. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Quality of end-of-life care in multiple myeloma: A 13-year analysis of a population-based cohort in Ontario, Canada. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Retrospective review of end-of-life care in the last month of life in older patients with multiple myeloma: what collaboration between haematologists and palliative care teams? [2020]

9. England pubmed.ncbi.nlm.nih.gov

Palliative care utilization, transfusion burden, and end-of-life care for patients with multiple myeloma. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Early Palliative Care and Its Role in Oncology: A Qualitative Study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Symptoms and anxiety predict declining health-related quality of life in multiple myeloma: A prospective, multi-centre longitudinal study. [2020]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Multiple myeloma in Niger Delta, Nigeria: complications and the outcome of palliative interventions. [2020]