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Palliative Care for Blood Cancer (PALS_CT Trial)

N/A

Recruiting

Led By Reanne Booker, PhD(c)

Research Sponsored by Alberta Health Services, Calgary

Eligibility Criteria Checklist

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

Must have

Patients: Clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy

Be older than 18 years old

Must not have

Patients: Patients undergoing HSCT for a non-malignant hematologic condition

Patients: Inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare early palliative care to standard care for patients and their family caregivers undergoing hematopoietic stem cell transplantation for blood cancers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on palliative and supportive care rather than direct medical treatments, side effects may not be applicable in the traditional sense. However, participants might experience emotional or psychological responses to discussions about their illness and future.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patient quality of life

Secondary study objectives

Family caregiver quality of life

Patient and family caregiver prognostic understanding

Patient symptom burden

Other study objectives

1 year overall survival

5 year overall survival

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: Palliative and Supportive Care InterventionExperimental Treatment1 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 CareActive Control1 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.

0 / 3Eligibility criteria met