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A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease.

Publication ,  Journal Article
Patel, SS; Hong, S; Rybicki, L; Farlow, S; Dabney, J; Kalaycio, M; Sobecks, R; Majhail, NS; Hamilton, BK
Published in: Transplant Cell Ther
July 2023

Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality after allogeneic hematopoietic cell transplantation (HCT). Acute GVHD is associated with severe physical and psychosocial symptoms. We sought to evaluate the feasibility of capturing patient-reported outcome (PRO) measures in acute GVHD to better measure symptom burden and quality of life (QOL). We conducted a pilot study of adult patients undergoing first allogeneic HCT. Questions from Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT), Patient-Reported Outcomes Measurement Information System (PROMIS-10), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were selected, and the survey was administered electronically before HCT, at days 14, 50, and 100 after HCT. In addition, patients who developed grade 2-4 acute GVHD received it weekly for 4 weeks and then monthly up to 3 months. From 2018 to 2020, 73 patients were consented, of which 66 went on to undergo HCT and were included in the analysis. Median age at transplantation was 63 years, and 92% were Caucasian. Only 47% of expected surveys were completed (range 0%-67% for each time point). Descriptive exploratory analysis demonstrate an expected trajectory of QOL using the FACT-BMT and PROMIS-10 scores throughout transplantation. Patients who developed acute GVHD (N = 15) generally had lower QOL scores compared to those with no or mild GVHD post-HCT. The PRO-CTCAE captured several physical and mental/emotional symptoms in all patients and those with GVHD. Fatigue (100%), decreased appetite (92%), problem tasting (85%), loose stools (77%), pain (77%), skin itching (77%), and depression (feeling sad) (69%) were the most prevalent symptoms among patients with grade 2-4 acute GVHD. Patients with acute GVHD generally reported worse symptoms than those with no/mild GVHD in frequency, severity, and interference in normal activities. Several challenges were identified including poor access/literacy of electronic surveys, acute illness, and need for extensive research/resource support. We demonstrate the challenges yet potential of using PRO measures in acute GVHD. We demonstrate that the PROMIS-10 and PRO-CTCAE measures are able to capture several symptoms and QOL domains of acute GVHD. Further investigation into making PROs feasible in acute GVHD are needed.

Duke Scholars

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Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

July 2023

Volume

29

Issue

7

Start / End Page

465.e1 / 465.e7

Location

United States

Related Subject Headings

  • Quality of Life
  • Pilot Projects
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Bone Marrow Transplantation
  • Adult
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences
 

Citation

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MLA
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Patel, S. S., Hong, S., Rybicki, L., Farlow, S., Dabney, J., Kalaycio, M., … Hamilton, B. K. (2023). A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease. Transplant Cell Ther, 29(7), 465.e1-465.e7. https://doi.org/10.1016/j.jtct.2023.03.030
Patel, Sagar S., Sanghee Hong, Lisa Rybicki, Stephanie Farlow, Jane Dabney, Matt Kalaycio, Ronald Sobecks, Navneet S. Majhail, and Betty K. Hamilton. “A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease.Transplant Cell Ther 29, no. 7 (July 2023): 465.e1-465.e7. https://doi.org/10.1016/j.jtct.2023.03.030.
Patel SS, Hong S, Rybicki L, Farlow S, Dabney J, Kalaycio M, et al. A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease. Transplant Cell Ther. 2023 Jul;29(7):465.e1-465.e7.
Patel, Sagar S., et al. “A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease.Transplant Cell Ther, vol. 29, no. 7, July 2023, pp. 465.e1-465.e7. Pubmed, doi:10.1016/j.jtct.2023.03.030.
Patel SS, Hong S, Rybicki L, Farlow S, Dabney J, Kalaycio M, Sobecks R, Majhail NS, Hamilton BK. A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease. Transplant Cell Ther. 2023 Jul;29(7):465.e1-465.e7.

Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

July 2023

Volume

29

Issue

7

Start / End Page

465.e1 / 465.e7

Location

United States

Related Subject Headings

  • Quality of Life
  • Pilot Projects
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Bone Marrow Transplantation
  • Adult
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences