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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early palliative care (extra support for serious illness) can improve life for patients with blood cancers who are about to start intense treatments like stem cell or CAR T-cell therapy. Researchers seek to assess whether this approach aids in managing symptoms and enhances life quality for both patients and their family caregivers. The trial will compare usual care with the addition of early palliative care. It is suitable for those diagnosed with a blood cancer, scheduled for these specific treatments, and proficient in English.

As an unphased trial, this study provides a unique opportunity to explore innovative care strategies that could enhance quality of life during challenging treatments.

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 prior data suggests that early palliative and supportive care is safe for patients undergoing HSCT or CAR T-cell therapy?

Research has shown that starting palliative care early is safe and well-received by cancer patients. Studies have found it improves quality of life and helps manage symptoms without causing major side effects. For those with advanced cancer, early palliative care can lead to a better understanding of their condition and greater satisfaction with their care.

In past experiences with patients receiving treatments like stem cell transplants and CAR T-cell therapy, early palliative care has proven helpful. It eases symptoms and might even help patients live longer. No strong evidence of safety issues exists with early palliative care, making it a comforting choice for those considering such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the palliative and supportive care intervention for blood cancer patients because it offers a personalized approach that starts early in the treatment process. Unlike standard care, which provides palliative support mainly upon request, this intervention involves proactive, regular meetings with a palliative care specialist right from the beginning of a patient's transplant or CAR T-cell therapy journey. This approach emphasizes education, symptom management, and emotional support, aiming to improve patients' quality of life and understanding of their treatment. By integrating consistent, early support, this method holds promise for better overall patient outcomes and coping strategies during a challenging treatment period.

What evidence suggests that early palliative care is effective for blood cancer patients?

Research has shown that starting palliative care early for cancer patients can better manage symptoms and provide a clearer understanding of the illness. In this trial, participants in the Palliative and Supportive Care Intervention arm will receive early palliative care, which studies have found often leads to a better quality of life and less emotional distress. For those with blood cancers, early palliative care is linked to less use of intense treatments like chemotherapy and fewer hospital visits near the end of life. Additionally, patients often live longer when palliative care is included early in their treatment plan. The American Society of Clinical Oncology strongly recommends this approach for patients with advanced or very symptomatic cancers. ^{2 3 6 7 8}

Who Is on the Research Team?

Reanne Booker, PhD(c)

Principal Investigator

AHS Calgary

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Early Palliative Care Services and End-of-Life ... Conclusion: Among patients with HM, there was an upward trend in PC services, and early PC services were associated with less aggressive EOL care. Our results ...