Patient Interviews about treatment and recruitment in the DANTE trial
Research type
Research Study
Full title
Patient interviews about treatment and recruitment to the DANTE trial
IRAS ID
236882
Contact name
Janine Bestall
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
The DANTE trial aims to evaluate whether patients with advanced melanoma receiving immunotherapy drugs called Ipilimumab or Nivolumab can achieve and maintain as good an outcome if they receive 12 months total treatment duration as compared with standard treatment duration, which is until disease progression or unacceptable toxicity of the drug. At the current time patients that respond to the treatment can stay on treatment for a number of years, however recent evidence has shown that patients could receive a shorter course of treatment and still maintain the same benefits of treatment whilst avoiding unpleasant side effects. Immunotherapy is a cancer treatment, which is designed to boost the body’s own defences to fight cancer. ‘Switching on the immune system’ is a strategy that should work in melanoma because sometimes melanomas spontaneously regress. Once the immune system is switched on, it causes the tumour to regress. The DANTE trial aims to recruit 1068 patients whose disease does not get worse after 6 months and then patients will either be randomised to a group who stop treatment after a further 6 months or continue with treatment. An internal pilot will be conducted to assess the feasibility of recruiting patients to this study and to act as a quality control. This qualitative study forms part of the insight from patients about the treatment and their experience of being recruited to the trial. In-depth interviews will be conducted with 18 patients (6 that choose not to be randomised; 6 that are in the control arm and 6 in the treatment arm) using a pre-defined topic guide. Interviews will be audio-recorded and transcribed verbatim and managed using NVivo. Data will be thematically analysed using a compare and contrast approach. The insight from this study aims to improve the quality of the trial.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0019
Date of REC Opinion
21 Feb 2018
REC opinion
Further Information Favourable Opinion