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An oral care self-management support protocol (OrCaSS) to reduce oral mucositis in hospitalized patients with acute myeloid leukemia and allogeneic hematopoietic stem cell transplantation: a randomized controlled pilot study

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Abstract

Introduction

Oral mucositis (OM) is a common and debilitating side effect of chemoradiotherapy in patients awaiting allogeneic hematopoietic stem cell transplantation (aHSCT).

Purpose

The aim of this pilot RCT was to compare an oral care self-management support protocol (OrCaSS) to usual pre-aHSCT care. Feasibility was tested, effect sizes calculated for OM (primary outcome), and patient adherence was measured (secondary outcome).

Methods

Eighteen AML patients awaiting aHSCT and hospitalized between August 2012 and April 2013 were randomized 1:1 to usual care (UCG) and intervention (IG) groups. The OrCaSS protocol consisted of two sessions of educational and behavioral interventions, the first delivered 1 week pre-admission (T1), the second on admission day (T2). Via field notes, practicability and acceptability were evaluated to explore the feasibility of intervention and study procedures. OM data were collected at T1, T2, and daily for 28 days using the WHO scale. The effect size r was calculated (r less than −0.1 ≙ small and greater than or equal to −0.3 ≙ medium). Patients’ adherence to the protocol was assessed at T1, T2, and 8–10 days post-HSCT (T3).

Results

Research and intervention procedures were feasible. OM incidence was 100 %. The IG’s median highest OM grade was 2.0 (IQR = 2); the UCGs was 3.0 (IQR = 2; r = −0.1). Median OM durations were 12 days in the IG and 14 days in the UCG (r = −0.1). OM onset was 2 days later in the IG than in the UCG (r = −0.1). Over the course of the study, patient adherence decreased in both groups.

Conclusions

OrCaSS is a promising intervention to delay and reduce OM. These results can serve to plan a larger RCT.

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Acknowledgments

The authors wish to thank Dr. med. dent Sebastjan Varljen for the support in dental questions, as well as Chris Shultis and Anne Rebafka for their assistance with language and formatting revision. Further, we wish to express our gratitude to Gila Sellam, Matthias Naegele, Therese Hirsbrunner, Sandra Schönfeld, Barbara Gresch, and Sulin Bänzinger of the Institute of Nursing Science, Basel, for reviewing this paper.

Conflict of interest

The authors declare that they have no conflicts of interest, have full control of all primary data, and allow the journal to review their data if requested.

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Authors and Affiliations

  1. Institute of Nursing Science, University of Basel, Bernoullistrasse 28, CH-4056, Basel, Switzerland

    Lynn Leppla, Sabina De Geest, Katharina Fierz & Antje Koller

  2. Department of Oncology, Hematology and Stem Cell Transplantation, University Medical Center Freiburg, Hugstetterstrasse 55, Freiburg, 79106, Germany

    Lynn Leppla, Barbara Deschler-Baier & Antje Koller

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  1. Lynn Leppla
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Correspondence to Sabina De Geest.

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Leppla, L., De Geest, S., Fierz, K. et al. An oral care self-management support protocol (OrCaSS) to reduce oral mucositis in hospitalized patients with acute myeloid leukemia and allogeneic hematopoietic stem cell transplantation: a randomized controlled pilot study. Support Care Cancer 24, 773–782 (2016). https://doi.org/10.1007/s00520-015-2843-1

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