title: 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.
abstract: BACKGROUND
  Oral mucositis (OM) is a common and debilitating side effect of chemoradiotherapy in patients awaiting allogeneic hematopoietic stem cell transplantation (aHSCT).
  
  
  OBJECTIVE
  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.
authors.affiliation: Institute of Nursing Science, University of Basel, Bernoullistrasse 28, CH-4056, Basel, Switzerland.|Department of Oncology, Hematology and Stem Cell Transplantation, University Medical Center Freiburg, Hugstetterstrasse 55, Freiburg, 79106, Germany.
authors.forename: Lynn
authors.initials: L
authors.lastname: Leppla
authors.affiliation: Institute of Nursing Science, University of Basel, Bernoullistrasse 28, CH-4056, Basel, Switzerland. Sabina.DeGeest@unibas.ch.
authors.forename: Sabina
authors.initials: S
authors.lastname: De Geest
authors.affiliation: Institute of Nursing Science, University of Basel, Bernoullistrasse 28, CH-4056, Basel, Switzerland.
authors.forename: Katharina
authors.initials: K
authors.lastname: Fierz
authors.affiliation: Department of Oncology, Hematology and Stem Cell Transplantation, University Medical Center Freiburg, Hugstetterstrasse 55, Freiburg, 79106, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Deschler-Baier
authors.affiliation: Institute of Nursing Science, University of Basel, Bernoullistrasse 28, CH-4056, Basel, Switzerland.|Department of Oncology, Hematology and Stem Cell Transplantation, University Medical Center Freiburg, Hugstetterstrasse 55, Freiburg, 79106, Germany.
authors.forename: Antje
authors.initials: A
authors.lastname: Koller
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015470:Leukemia, Myeloid, Acute; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012648:Self Care / Q000379:methods*; D013280:Stomatitis / Q000209:etiology / Q000628:therapy*; D014184:Transplantation, Homologous; D016896:Treatment Outcome
keywords: Allogeneic stem cell transplantation; Oral care protocol; Oral mucositis