Early Integration of Palliative and Supportive Care in Cellular Therapy

NCT05190653 | Recruiting DMC

• 1 other identifier: 27265
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Blood Cancer; Stem Cell Transplant Complications; Chimeric Antigen Receptor T-cell Therapy

Keywords

palliative care; supportive care; quality of life; symptom burden; hematologic malignancies

Outcome Measures

Primary Outcomes (1)

• Patient quality of life

  The primary outcome of the study, QOL, will be assessed using the McGill Quality of Life Questionnaire - Expanded (MQOL-E) summary score of QOL monthly for a period of three months. The MQOL-E consists of 21 items with possible scores of 0 to 10 for each item. The higher the score, the better the QOL. The trajectories of QOL will be evaluated rather than looking at change in scores as it is anticipated that there will be significant fluctuation in QOL scores over time. The Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) will also be used to measure QOL. The FACT-BMT is more specific to BMT and may capture issues that are unique to BMT. The FACT-BMT consists of 47 items; a 5-point Likert-type scale is used for item. The total score ranges from 0-196 and higher scores indicate better QOL.

  3 months

Secondary Outcomes (3)

• Patient symptom burden

  3 months

• Patient and family caregiver prognostic understanding

  3 months

• Family caregiver quality of life

  3 months

Other Outcomes (2)

• 1 year overall survival

  1 year

• 5 year overall survival

  5 years

Study Arms (2)

Palliative and Supportive Care Intervention

EXPERIMENTAL

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.

Other: Early palliative and supportive care

Standard Care

NO 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.

Interventions

Early palliative and supportive care OTHER

The intervention itself will be predominantly the provision of education and information. It is possible that patients in the intervention arm may receive treatment recommendations to help manage symptoms.

Palliative and Supportive Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy
• Ability to speak, read, and understand English or, be able to complete questionnaires with minimal assistance required from an interpreter
• Family caregivers of patients with a clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy
• A spouse, relative, or friend, identified by the patient, who either lives with the patient or has in-person contact with the patient at least twice per week. Only one family CG per patient will be asked to participate.
• Ability to speak, read, and understand English or willing to complete questionnaires with minimal assistance required from an interpreter

You may not qualify if:

• Patients undergoing HSCT for a non-malignant hematologic condition
• Inability to provide informed consent
• \* Inability to provide informed consent

Sponsors & Collaborators

• Alberta Health Services, Calgary: lead
• Alberta Cancer Foundation: collaborator
• University of Victoria: collaborator

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

RECRUITING

Related Publications (11)

• El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, Jackson VA, Telles J, Rhodes A, Spitzer TR, McAfee S, Chen YA, Lee SS, Temel JS. Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2016 Nov 22;316(20):2094-2103. doi: 10.1001/jama.2016.16786.

  PMID: 27893130 BACKGROUND

• Hui D, Didwaniya N, Vidal M, Shin SH, Chisholm G, Roquemore J, Bruera E. Quality of end-of-life care in patients with hematologic malignancies: a retrospective cohort study. Cancer. 2014 May 15;120(10):1572-8. doi: 10.1002/cncr.28614. Epub 2014 Feb 18.

  PMID: 24549743 BACKGROUND

• Hui D, Hannon BL, Zimmermann C, Bruera E. Improving patient and caregiver outcomes in oncology: Team-based, timely, and targeted palliative care. CA Cancer J Clin. 2018 Sep;68(5):356-376. doi: 10.3322/caac.21490. Epub 2018 Sep 13.

  PMID: 30277572 BACKGROUND

• Kaasa S, Loge JH, Aapro M, Albreht T, Anderson R, Bruera E, Brunelli C, Caraceni A, Cervantes A, Currow DC, Deliens L, Fallon M, Gomez-Batiste X, Grotmol KS, Hannon B, Haugen DF, Higginson IJ, Hjermstad MJ, Hui D, Jordan K, Kurita GP, Larkin PJ, Miccinesi G, Nauck F, Pribakovic R, Rodin G, Sjogren P, Stone P, Zimmermann C, Lundeby T. Integration of oncology and palliative care: a Lancet Oncology Commission. Lancet Oncol. 2018 Nov;19(11):e588-e653. doi: 10.1016/S1470-2045(18)30415-7. Epub 2018 Oct 18.

  PMID: 30344075 BACKGROUND

• Temel JS, Greer JA, El-Jawahri A, Pirl WF, Park ER, Jackson VA, Back AL, Kamdar M, Jacobsen J, Chittenden EH, Rinaldi SP, Gallagher ER, Eusebio JR, Li Z, Muzikansky A, Ryan DP. Effects of Early Integrated Palliative Care in Patients With Lung and GI Cancer: A Randomized Clinical Trial. J Clin Oncol. 2017 Mar 10;35(8):834-841. doi: 10.1200/JCO.2016.70.5046. Epub 2016 Dec 28.

  PMID: 28029308 BACKGROUND

• Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

  PMID: 20818875 BACKGROUND

• Gray TF, Temel JS, El-Jawahri A. Illness and prognostic understanding in patients with hematologic malignancies. Blood Rev. 2021 Jan;45:100692. doi: 10.1016/j.blre.2020.100692. Epub 2020 Apr 6.

  PMID: 32284227 BACKGROUND

• Hochman MJ, Yu Y, Wolf SP, Samsa GP, Kamal AH, LeBlanc TW. Comparing the Palliative Care Needs of Patients With Hematologic and Solid Malignancies. J Pain Symptom Manage. 2018 Jan;55(1):82-88.e1. doi: 10.1016/j.jpainsymman.2017.08.030. Epub 2017 Sep 5.

  PMID: 28887271 BACKGROUND

• Ferrell BR, Temel JS, Temin S, Alesi ER, Balboni TA, Basch EM, Firn JI, Paice JA, Peppercorn JM, Phillips T, Stovall EL, Zimmermann C, Smith TJ. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Jan;35(1):96-112. doi: 10.1200/JCO.2016.70.1474. Epub 2016 Oct 28.

  PMID: 28034065 BACKGROUND

• El-Jawahri A, Nelson AM, Gray TF, Lee SJ, LeBlanc TW. Palliative and End-of-Life Care for Patients With Hematologic Malignancies. J Clin Oncol. 2020 Mar 20;38(9):944-953. doi: 10.1200/JCO.18.02386. Epub 2020 Feb 5.

  PMID: 32023164 BACKGROUND

• El-Jawahri A, Traeger L, Kuzmuk K, Eusebio J, Vandusen H, Keenan T, Shin J, Gallagher ER, Greer JA, Pirl WF, Jackson VA, Ballen KK, Spitzer TR, Graubert TA, McAfee S, Dey B, Chen YB, Temel JS. Prognostic understanding, quality of life and mood in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2015 Aug;50(8):1119-24. doi: 10.1038/bmt.2015.113. Epub 2015 May 11.

  PMID: 25961772 BACKGROUND

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Hematologic Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Reanne Booker, PhD(c)

  AHS Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reanne Booker, PhD(c)

CONTACT

403-990-1425; Reanne.booker@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It will not be possible to blind participants or researchers (PC clinicians who will be involved in delivery the intervention) to the intervention but the individual doing the data collection, the research assistant, will be blinded to the randomization allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 13, 2022
• Study Start: April 8, 2022
• Primary Completion: April 8, 2025
• Study Completion: December 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)