10.1007_s10549-020-05798-w.pdf (537.49 kB)
The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer
journal contribution
posted on 2023-06-07, 07:40 authored by Helena HarderHelena Harder, Valerie ShillingValerie Shilling, Shirley May, David Cella, Peter Schmid, Lesley FallowfieldLesley FallowfieldPurpose Chemotherapy-induced diarrhoea (CID) is a common, but often underreported problem in patients with breast cancer that has a profound effect on quality of life. It is best measured from a patient’s perspective, but tools are limited. The aim of this study was to develop and evaluate the Diarrhoea Management Diary (DMD), a self-report measure to assess CID, use of self-management strategies and treatment adherence. Methods The DMD was constructed using an iterative process of instrument development: concept elicitation (literature review), item generation and reduction (cognitive debriefing), and pilot testing in the target population. After translation into eight languages, the DMD was used in an international randomised trial for women receiving lapatinib and capecitabine for metastatic breast cancer with or without prophylactic octreotide. Patterns of missing data and sensitivity to change were examined. Results The understandability and completeness of the 8-item DMD was confirmed in cognitive interviews and pilot testing. Practicability of the DMD was evaluated in 62 women with metastatic breast cancer (median age 57). Up to 68% reported CID at any given time-point, and 19% had diarrhoea at each time-point. Patients also described efficacy of different strategies for diarrhoea management. Missing data were associated with study discontinuation. DMD missing item response was 0.9%. Sensitivity to change was good at most assessment points. Conclusions Although further psychometric testing is recommended, initial evaluation of the DMD showed good content validity and practicability in international research with cancer patients.
History
Publication status
- Published
File Version
- Published version
Journal
Breast Cancer Research and TreatmentISSN
0167-6806Publisher
SpringerExternal DOI
Page range
1-10Department affiliated with
- Sussex Health Outcomes Research & Education in Cancer (SHORE-C) Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2020-08-04First Open Access (FOA) Date
2020-08-04First Compliant Deposit (FCD) Date
2020-08-04Usage metrics
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