Co-Investigator - Prof Dame Lesley Fallowfield
Co-Investigator - Dr Valerie Shilling
Co-Investigator - Dr Helena Harder
Data Manager - Shirley May
Funder: Novartis
RELATED is a multi-centre international randomised controlled trial that evaluated the efficacy of prophylactic octreotide in the prevention or reduction of diarrhoea in patients receiving lapatinib with capecitabine for the treatment of advanced or metastatic breast cancer.
Diarrhoea is a frequent adverse effect of cancer therapy and although the intensity of symptoms may vary among patients, it often interferes with daily activities and has a deleterious effect on patient's well-being and overall quality of life (QoL). In some cases the diarrhoea is so severe that it results in treatment interruption or dose reduction, and consequently potentially reduces the therapeutic benefit of the cancer treatment.
Previous research shows that diarrhoea and other adverse events are often under-reported within the context of a clinical trial, and that the effects of diarrhoea on patient's wellbeing may not be reflected in the investigator-reported outcomes recorded by standard clinician toxicity assessment tools (e.g. CTCAE grading).
In the RELATED study we explored the impact of treatment-related diarrhoea from the patient's perspective by collecting patient-reported outcome data before and over the course of the treatment. The overall effect that diarrhoea had on physical, functional, emotional and social well-being was measured with the FACIT-D. A study-specific diarrhoea management diary was developed by SHORE-C to obtain insight on how patients manage or control diarrhoea. This diary was completed weekly for 24 weeks by patients and also measured their adherence to the treatment regimen. A total of 62 patients with metastatic breast cancer were enrolled in the study. Up to 68% reported CID, and almost one in five patients reported diarrhoea at each study time point. Initial evaluation of the DMD showed good content validity and practicability. Further psychometric testing was recommended and is currently underway.
Current Stage:
Closed
Publication
The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer https://doi.org/10.1007/s10549-020-05798-wPoster
Measuring diarrhoea in a cancer setting: the importance of patient-reported tools posters/BPOSrelatedFeb20.pdf Presented at British Psychosocial Oncology Society (BPOS) conference 2020