Stem cell transplantation patients receiving a novel oral care protocol for oral mucositis prevention and treatment: patient-reported outcomes and quality of life.


Journal

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
ISSN: 1433-7339
Titre abrégé: Support Care Cancer
Pays: Germany
ID NLM: 9302957

Informations de publication

Date de publication:
Jul 2022
Historique:
received: 14 02 2022
accepted: 18 04 2022
pubmed: 28 4 2022
medline: 31 5 2022
entrez: 27 4 2022
Statut: ppublish

Résumé

Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hematopoietic stem cell transplantation (HSCT) conditioning regimens. The aim of this secondary analysis of the data of a phase II study designed to assess the efficacy of a novel oral care protocol containing bovine colostrum and aloe vera to prevent oral mucositis was to compare outcomes reported by patients with those collected by healthcare professionals (HCPs). Data on oral mucositis severity, duration, time of onset and related pain were collected from patients using the Oral Mucositis Daily Questionnaire (OMDQ). HCPs assessed the same outcomes using the World Health Organization oral mucositis scale and pain numerical rating scale. Quality of life was assessed with the 3-level EuroQol-5 dimensions. Fifty-nine autologous/allogeneic graft patients were recruited, 46 of whom (78.0%) experienced OM. Mean onset was 9.1 (SD ± 3.5) days after conditioning initiation, mean duration was 10.4 (SD ± 4.3) days, and the average maximum pain score was 3.7 (SD ± 2.7). Self-administration of the OMDQ detected oral symptoms at least 1 day sooner compared to objective assessments (p = 0.025). Significant differences were observed between the patient-reported and the HCP-assessment data on oral mucositis severity grading distribution (p < 0.0001) and highest pain score (p < 0.0001). Quality of life score variations were correlated with changes in oral mucositis severity during patients' hospital stay. Further studies are necessary to improve the understanding of these findings; a randomised controlled trial is being set up at our institution.

Sections du résumé

BACKGROUND BACKGROUND
Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hematopoietic stem cell transplantation (HSCT) conditioning regimens. The aim of this secondary analysis of the data of a phase II study designed to assess the efficacy of a novel oral care protocol containing bovine colostrum and aloe vera to prevent oral mucositis was to compare outcomes reported by patients with those collected by healthcare professionals (HCPs).
METHOD METHODS
Data on oral mucositis severity, duration, time of onset and related pain were collected from patients using the Oral Mucositis Daily Questionnaire (OMDQ). HCPs assessed the same outcomes using the World Health Organization oral mucositis scale and pain numerical rating scale. Quality of life was assessed with the 3-level EuroQol-5 dimensions.
RESULTS RESULTS
Fifty-nine autologous/allogeneic graft patients were recruited, 46 of whom (78.0%) experienced OM. Mean onset was 9.1 (SD ± 3.5) days after conditioning initiation, mean duration was 10.4 (SD ± 4.3) days, and the average maximum pain score was 3.7 (SD ± 2.7). Self-administration of the OMDQ detected oral symptoms at least 1 day sooner compared to objective assessments (p = 0.025). Significant differences were observed between the patient-reported and the HCP-assessment data on oral mucositis severity grading distribution (p < 0.0001) and highest pain score (p < 0.0001). Quality of life score variations were correlated with changes in oral mucositis severity during patients' hospital stay.
CONCLUSIONS CONCLUSIONS
Further studies are necessary to improve the understanding of these findings; a randomised controlled trial is being set up at our institution.

Identifiants

pubmed: 35474550
doi: 10.1007/s00520-022-07073-8
pii: 10.1007/s00520-022-07073-8
pmc: PMC9135813
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

6317-6325

Informations de copyright

© 2022. The Author(s).

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Auteurs

Monica Guberti (M)

Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Via Montpellier 1, 00133, Rome, Italy.
Research and EBP Unit, Health Professions Department, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy.

Stefano Botti (S)

Hematology Unit, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy. stefano.botti@ausl.re.it.
Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy. stefano.botti@ausl.re.it.

Andrea Fusco (A)

Research and EBP Unit, Health Professions Department, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy.

Cristiana Caffarri (C)

Hematology Unit, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy.

Silvio Cavuto (S)

Clinical Trials and Statistics Unit, SC Infrastructure, Research and Statistics, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42123, Reggio Emilia, Italy.

Luisa Savoldi (L)

Clinical Trials and Statistics Unit, SC Infrastructure, Research and Statistics, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42123, Reggio Emilia, Italy.

Nicola Serra (N)

Department of Public Health, University Federico II of Naples, via S. Pansini 5, 80131, Naples, Italy.

Francesco Merli (F)

Hematology Unit, Azienda USL-IRCCS Di Reggio Emilia, Via Amendola 2, 42122, Reggio Emilia, Italy.

Michela Piredda (M)

Research Unit Nursing Science, University Campus Bio-Medico of Rome, Via Alvaro del Portillo 21, 00128, Rome, Italy.

Maria Grazia De Marinis (MG)

Research Unit Nursing Science, University Campus Bio-Medico of Rome, Via Alvaro del Portillo 21, 00128, Rome, Italy.

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