Survey: Metastatic breast cancer patients and hepatic resections- V1
Research type
Research Study
Full title
Survey on whether patient with metastatic breast cancer would be willing to participate in a randomized controlled trial randomizing to partial hepatic resection or no hepatic resection of breast cancer metastasis (Feasibility study)
IRAS ID
189983
Contact name
Beatrix Elsberger
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
0 years, 2 months, 20 days
Research summary
This survey aim to establish whether patient with breast cancer that has spread (metastasis) would be willing to participate in a randomized controlled trial (RCT) randomizing to partial liver surgery or no liver surgery. It is part of a larger study, the RCT, to ensure that there would be sufficient uptake before setting up the RCT which could be costly and time-consuming.
Breast cancer with liver metastasis is common in UK. Liver surgery to manage such condition should be considered. Although this is supported by literature review, the current evidence is poor as they are only based on retrospective case series. Thus, RCT serving as prospective cohort study is important to establish the role of liver surgery in managing breast cancer with liver metastasis.
The survey will be carried out in Maggie's Centres, Tayside and Fife. The clinical leads of Maggie's Centre, Dr.Howells will help to identify participants who are eligible and willing to participate in this survey. Participants who are eligible for this survey include female from 18 to 80 years old with metastatic breast cancer, regardless of tumour types, grades, hormonal status and axillary lymph node positivity. All participants would be given participant information sheets one month before the survey.
During the meeting in Maggie Centre, the CI, Miss Elsberger Beatrix along with 4th year medical student, Sze Ming Ong would take written consent from the participants and guide them through a questionnaire with 11 questions. Participants would be informed that participation in this survey is completely voluntary and agreeing or refusing to participate will not affect their treatment in any way. They would also have the opportunity to ask questions at any time. Dr Howells who is a consultant clinical psychologist would offer psychological support if required. Completing the questionnaire should take no longer than 30 minutes.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
16/ES/0006
Date of REC Opinion
19 Feb 2016
REC opinion
Further Information Favourable Opinion