Palliative Care for Blood Cancer

(PALS_CT Trial)

Overseen By Reanne Booker, PhD(c)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alberta Health Services, Calgary

Disqualifiers: Non-malignant conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 months

152 Participants Needed

Trial Summary

What is the purpose of this trial?

Research has shown that early palliative care in cancer care is associated with improved symptom management, better prognostic understanding, improved quality of life for patients and family caregivers, and even improved survival. Yet, in spite of the proven benefits of integration of palliative care in oncology, it has been well established that patients with hematologic malignancies and those undergoing cellular therapy (hematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor (CAR) T-cell therapy) do not routinely receive palliative care. Most of the published research on the early integration of palliative care in oncology describes studies that have involved patients with solid tumours. To date, only one randomized trial examining the impact of integrated palliative care among patients undergoing HSCT has been published and there have been no studies examining the impact of integrated palliative care for patients undergoing CAR T-cell therapy. The American Society of Clinical Oncology recommends early palliative care for patients with advanced cancers or for those with high symptom burden. Patients with blood cancers experience high symptom burden and in the last 30 days of life, compared to patients with solid tumours, patients with blood cancers are more likely to die in hospital, have more intensive care unit admissions, have prolonged hospitalizations (\>14 days), and pass away in an acute care facility. There is an urgent need to proactively address suffering throughout cellular therapy trajectories, even before treatment starts, so that patients and caregivers are not inevitably waiting for symptoms to arise before they can be addressed and to optimize quality of life for patients undergoing transplant as well as their family caregivers. PALS_CT will compare early palliative care to standard care for patients and their family caregivers undergoing HSCT or CAR T-cell therapy for blood cancers.

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Early palliative and supportive care for blood cancer?

Research shows that early palliative care can improve the quality of life and reduce symptom severity in patients with advanced cancer. This suggests that similar benefits might be seen in blood cancer patients receiving early palliative and supportive care. ^{1 2 3 4 5}

Is early palliative and supportive care safe for humans?

The research suggests that early palliative and supportive care is generally safe for patients with advanced cancer, as it is recommended by international medical organizations and is associated with improved quality of life. ^{1 2 6 7 8}

How is the treatment 'Early palliative and supportive care' different for blood cancer patients?

Early palliative and supportive care is unique for blood cancer patients because it focuses on improving quality of life by integrating care earlier in the disease process, unlike traditional approaches that often start palliative care only at the end of life. This treatment addresses specific needs like symptom control and transfusion requirements, which are particularly important for patients with blood cancers. ^{1 9 10 11 12}

Research Team

Reanne Booker, PhD(c)

Principal Investigator

AHS Calgary

Eligibility Criteria

This trial is for patients with blood cancers like leukemia, lymphoma, or multiple myeloma who are scheduled for stem cell transplants or CAR-T therapy. They must understand English well enough to complete questionnaires. Their family caregivers can also join if they're in close contact at least twice a week and meet similar language criteria.

Inclusion Criteria

I am a family caregiver for someone with blood cancer scheduled for stem cell transplant or CAR T-cell therapy.

I am diagnosed with a blood cancer and scheduled for a stem cell transplant or CAR T-cell therapy.

Patients: Ability to speak, read, and understand English or, be able to complete questionnaires with minimal assistance required from an interpreter

Exclusion Criteria

I am having a stem cell transplant for a blood condition that is not cancer.

I am unable to understand or sign the consent form.

Family Caregivers: Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants meet with a palliative care nurse practitioner or physician to discuss palliative and supportive care, symptom management, and treatment expectations

1-2 weeks

1-2 visits (virtual or in-person)

Treatment

Participants undergo HSCT or CAR T-cell therapy with integrated palliative care intervention

3 months

Weekly visits (virtual or in-person)

Follow-up

Participants are monitored for quality of life and symptom burden post-treatment

3 months

Monthly assessments (remote)

Long-term Follow-up

Participants' survival and quality of life are assessed at 1 and 5 years post-study enrollment

5 years

Treatment Details

Interventions

• Early palliative and supportive care

Trial Overview The PALS_CT study is testing whether getting palliative and supportive care early on helps improve the quality of life for patients undergoing stem cell transplants or CAR-T therapy, as well as their family caregivers, compared to standard care.

Participant Groups

Group I: Palliative and Supportive Care Intervention Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will meet (either by phone or Zoom contingent upon participant preference) with a palliative care nurse practitioner or palliative care physician. During the first meeting, pre-transplant/CAR T-cell therapy, content will focus on the provision of information and education, including: a description of palliative and supportive care, symptom management, advance care planning, prognostic and illness understanding and treatment expectations, and coping strategies. All subsequent visits will include, at minimum, these topics. All meetings will be audio-recorded using a handheld audio-recorder; the record feature of Zoom will not be utilized. Participants in the intervention arm will meet with a member of the study team (palliative care nurse practitioner or palliative care physician) one to two times weekly, or more frequently if requested by the patient and/or family caregiver, until 3 months post-transplant/CAR T-cell therapy.

Group II: Standard Care Active Control 1 Intervention

Standard care will involve the usual care that patients undergoing HSCT/CAR T-cell therapy would be expected to receive, including palliative care consultation as needed or upon request. Palliative care interventions beyond what are provided in the study will be tracked in both the intervention and the standard care arms.

Early palliative and supportive care is already approved in United States, European Union for the following indications:

Approved in United States as Early palliative care for:

• Hematologic malignancies
• Blood cancers
• Advanced cancers
• High symptom burden

Approved in European Union as Early palliative care for:

• Hematologic malignancies
• Blood cancers
• Advanced cancers
• High symptom burden

Who Is Running the Clinical Trial?

Alberta Health Services, Calgary

Lead Sponsor

Trials

15

Recruited

2,600+

University of Victoria

Collaborator

Trials

59

Recruited

12,000+

Alberta Cancer Foundation

Collaborator

Trials

18

Recruited

5,600+

Findings from Research

In a study of 215 patients with acute myeloid leukaemia receiving early palliative supportive care, over 50% met four or more quality indicators for palliative care, indicating effective implementation of supportive measures.

Patients receiving early palliative care showed low rates of aggressive treatments at the end of life, with only 2.7% undergoing chemotherapy in the last 14 days and many dying at home or in hospice, suggesting a focus on comfort rather than intensive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early palliative/supportive care in acute myeloid leukaemia allows low aggression end-of-life interventions: observational outpatient study. Potenza, L., Scaravaglio, M., Fortuna, D., et al.[2021]

This study will assess the impact of 'Enhanced Supportive Care', an early palliative care intervention provided by nurses, on the quality of life and symptoms of 360 advanced cancer patients undergoing chemotherapy, with evaluations at 3 and 6 months.

The trial aims to provide evidence on how early palliative care can improve not only patient outcomes, such as coping and depression, but also the well-being of caregivers, potentially enhancing overall cancer care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. Choi, YY., Rha, SY., Cho, S., et al.[2022]

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]

Patients and caregivers reported feeling supported and guided through their illness and healthcare navigation when receiving early palliative care, highlighting the importance of personalized symptom management and holistic support.

No distress was reported from the intervention, even among patients who were unsure about their need for palliative care, suggesting that early palliative care can be safely integrated into cancer treatment without causing additional anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of patients and caregivers with early palliative care: A qualitative study. Hannon, B., Swami, N., Rodin, G., et al.[2022]

Early palliative care (EPC) significantly improves the quality of life (QoL) for patients with advanced cancer, based on a systematic review of 12 randomized controlled trials involving various interventions.

While EPC shows positive effects on QoL, it does not significantly impact mood or symptom control, indicating that further research is needed to optimize these interventions and determine the best timing for their implementation.

NCBI (Pubmed)

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. Gautama, MSN., Damayanti, A., Khusnia, AF.[2023]

There is a significant gap in palliative care practices for patients with hematological cancers, as highlighted by the experiences of family members and caregivers during institutional deaths.

The study emphasizes the urgent need for changes in current practices to improve the quality of palliative care in oncology, particularly for hematology patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dying in the curative system: the haematology/oncology dilemma. Part 2. McGrath, P.[2013]

A multicenter randomized controlled trial involving 150 adult patients with advanced cancer found that a structured early palliative care intervention did not significantly reduce patient distress or improve health-related quality of life after 6 months compared to usual oncology care.

The study suggests that patients with advanced cancer may require more intensive and continuous palliative care support to effectively address their needs and improve their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single early palliative care intervention added to usual oncology care for patients with advanced cancer: A randomized controlled trial (SENS Trial). Eychmüller, S., Zwahlen, S., Fliedner, MC., et al.[2021]

The EVI project aims to implement early palliative care in Comprehensive Cancer Centers, evaluating its impact on patient quality of life and the economic burden on families, with a focus on patients with metastatic cancer.

This multi-center study will involve hiring palliative care physicians to establish care structures and offer consultations within eight weeks of diagnosis, assessing patient outcomes through standardized questionnaires and qualitative interviews over an 18-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Palliative Care-Health services research and implementation of sustainable changes: the study protocol of the EVI project. Meffert, C., Gaertner, J., Seibel, K., et al.[2018]

Early palliative care combined with standard treatment for patients with haematological cancers is an important area of research, but current studies are limited and lack robust design, with only eight articles meeting the criteria for review.

The evidence available suggests that while early palliative care may impact quality of life and resource use, the overall quality of studies is low, indicating a need for more well-designed research to better understand its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early palliative care in haematological patients: a systematic literature review. Tanzi, S., Venturelli, F., Luminari, S., et al.[2021]

Early palliative care can significantly enhance the quality of life for patients with serious illnesses, but it is underutilized in patients with hematologic malignancies, who face unique challenges such as high illness burden and aggressive end-of-life care.

The article identifies barriers to integrating palliative care in hematology and discusses successful examples of its implementation, emphasizing the need for targeted strategies to improve palliative care access for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Palliative Care for Patients with Hematologic Malignancies: Is It Really so Difficult to Achieve? LeBlanc, TW., Roeland, EJ., El-Jawahri, A.[2021]

Palliative care is increasingly recognized as essential throughout the course of illness, yet patients with haematological malignancies often receive it later than those with other cancers, highlighting a need for earlier integration.

Effective communication and tailored strategies are crucial for providing palliative care to patients with haematological malignancies, considering their unique treatment needs and the complexities of their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care of patients with haematological malignancies: strategies to overcome difficulties via integrated care. Wedding, U.[2022]

Palliative care for patients with haematological malignancies is often limited to end-of-life situations, with many patients receiving late referrals, indicating a need for earlier intervention.

Patients and families generally report satisfaction with palliative care, but there is a significant symptom burden in haematological malignancies compared to non-haematological cancers, highlighting the need for improved collaboration between palliative care and onco-haematology departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care in patients with haematological neoplasms: An integrative systematic review. Moreno-Alonso, D., Porta-Sales, J., Monforte-Royo, C., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Early palliative/supportive care in acute myeloid leukaemia allows low aggression end-of-life interventions: observational outpatient study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Experiences of patients and caregivers with early palliative care: A qualitative study. [2022]

5. 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]

6. Australia pubmed.ncbi.nlm.nih.gov

Dying in the curative system: the haematology/oncology dilemma. Part 2. [2013]

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

Single early palliative care intervention added to usual oncology care for patients with advanced cancer: A randomized controlled trial (SENS Trial). [2021]

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

Early Palliative Care-Health services research and implementation of sustainable changes: the study protocol of the EVI project. [2018]

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

Early palliative care in haematological patients: a systematic literature review. [2021]

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

Early Palliative Care for Patients with Hematologic Malignancies: Is It Really so Difficult to Achieve? [2021]

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

Palliative care of patients with haematological malignancies: strategies to overcome difficulties via integrated care. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Palliative care in patients with haematological neoplasms: An integrative systematic review. [2019]