The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer

Helena Harder,David Cella,Valerie M Shilling,Lesley J Fallowfield,Shirley F May,Peter Schmid

doi:10.1007/s10549-020-05798-w

Abstract

PurposeChemotherapy-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.MethodsThe 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.ResultsThe 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.ConclusionsAlthough further psychometric testing is recommended, initial evaluation of the DMD showed good content validity and practicability in international research with cancer patients.

Highlights

Chemotherapy-induced diarrhoea (CID) is an important and commonly observed adverse event (AE) of particular relevance with 5-fluorouracil, irinotecan, capecitabine, anthracyclines, monoclonal antibody or small-molecule therapies [1,2,3,4,5,6,7]
To examine the sensitivity to change of the Diarrhoea Management Diary (DMD) capture of self-reported diarrhoea, we looked at the association between self-report of diarrhoea or not at each time-point with meaningful change on the FACIT DS
This paper described the development and initial evaluation of the DMD, a scale that measures symptoms and self-care and management strategies of diarrhoea, including adherence to treatment

Summary

Introduction

Chemotherapy-induced diarrhoea (CID) is an important and commonly observed adverse event (AE) of particular relevance with 5-fluorouracil, irinotecan, capecitabine, anthracyclines, monoclonal antibody or small-molecule therapies [1,2,3,4,5,6,7]. The prevalence and severity may vary depending on chemotherapeutic regimen and dosage, but severe diarrhoea has been reported by up to 50% of treated patients [1]. It is usually managed symptomatically with antidiarrheal agents, diet modification and hydration [2]. The widely adopted Common Terminology Criteria for Adverse Events (CTCAE) developed by the US National Cancer Institute (NCI), are the current standard for identification and grading of treatment-related AEs, including diarrhoea [14]. Medication factors (toxicity, AEs) were associated with nonadherence, if CID is not managed well, patients may stop taking their medication, reducing potential treatment efficacy

Objectives

Methods

Results

Conclusion