Study to pilot-test an oral care self-management support protocol (OrCaSS) regarding feasability and effectiveness in patients with acute myeloid leukemia prior to allogeneic stem cell transplantation to prevent chemotherapy-related oral mucositis: a randomized, controlled pilot study

Not Applicable

• Conditions: K12.3; Oral mucositis (ulcerative)

• Registration Number: DRKS00004309
• Lead Sponsor: niversitätsklinikum FreiburgAbteilung Hämatologie/Onkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-16
• Study Completion: 2013-05-01
• Results First Posted: 2015-07-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Read and speak German, have no oral mucositis at the time of recruitment, are to perform oral care independently in the situation

Exclusion Criteria

diagnosed psychiatric disorderor any other disabilities which prevents an adequate communication

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration, severity and incidence of OM<br><br>OM is measured daily with the WHO toxicity scale from the day of admission until day 20 after transplantation

Secondary Outcome Measures

Name	Time	Method
Adherence: is measured with the BAASIS and the plaque index on day of admission and at day 8,9 or 10 after transplantation <br><br>Quality of life: is measured using the EORTC QLQ C30 1 week before transplantation, at the day of admission and at day 8,9 or 10 after transplantation<br><br>Symptom Experience: is measured using PROVIVO at day 8,9 or 10 after transplantation<br>