Advances in the understanding of the biological basis of cancer have resulted in a paradigm shift in drug development. Phase I trials with translational elements are conducted in clinical trials units for patients with cancer. The objective of this study was to evaluate any unmet needs of support and information for patients on Phase I trials. The aim was to utilise patient exerience to assess the need to change or develop delivery of information and support.
A qualitative approach was used. Patients and relatives of patients with cancer on Phase I trials formed two focus group. Group 1 consisted of 8 participants and group 2 10 participants, both lasted one hour. A semi structured schedule was used to prompt discussion, the focus groups were audio-recorded and transcribed verbatim. The data were organised using the Nvivo software package and analysed using Braun and Clarke's thematic analysis framework.
Four themes emerged from the data 1) face to face support; there was a general consensus that the best way to recieve information about treatment and disease was face to face. The relationships with the clinical staff were strong and important to maintain. At times when the trials unit was not accessible patients felt vulnerable 2) remote support; email was felt to be a good way to communicate information regarding appointments, the telephone clinic was useful for contact regarding sympton issues. Digital methods of information and support were potentially useful but needed to be thought through properly 3) getting the right information, at the right time , in the right way; patients felt that they needed extra information particularly in terms of feedback regarding the trials and signposting to support services 4) Relationships with other patients; this theme was about the benefit and value patients had in supporting each other within the treatment areas, however this was conflicted and may require extra support at times as there was a negative impact when fellow patients became unwell or died.
Based on the results from the analysis written patient information was redesigned. A quarterly forum is in development where patients can meet recieve well being advice and also feedback regarding the trials they are participating in.
Clinical trial identification
Legal entity responsible for the study
Royal Marsden NHS Foundation Trust.
Has not received any funding.
All authors have declared no conflicts of interest.