SPRUCE
Research type
Research Study
Full title
A study within a trial of electronic versus paper based patient reported outcomes collection
IRAS ID
295218
Contact name
Rebecca Lewis
Contact email
Sponsor organisation
The Institute of Cancer Research
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Clinical trials units (CTUs) often ask trial participants to fill out questionnaires about their symptoms and overall health to collect data on the impact of their treatment. These are called patient reported outcomes (PRO) and questionnaires are normally distributed to trial participants as paper booklets either by post or at the hospital where the patient has their treatment. It is time consuming for patients to fill in these questionnaires, and takes work from the CTUs to distribute them and record the data when they are returned.
The aim of the SPRUCE research study is to find out whether we can use technology in the form of electronic questionnaires to improve the process of collecting PROs for both patients and the CTUs.
This study will include participants of current clinical trials of cancer treatments. Participants will be divided into two groups, one doing the questionnaires electronically and one doing them on paper. Patients will be eligible if they are enrolled in a participating trial. They will be asked if they are happy to be randomly allocated to receive electronic or paper questionnaires. If they are uncomfortable being randomly allocated or are unable to participate, eg due to lack of technological equipment at home, we will offer them the chance to participate in the group of their own preference.
The questionnaires will be sent at regular intervals over a one year period. Participants in the electronic group will receive an email with a link to a secure website to complete the questionnaire. Participants in the paper group will be sent the questionnaire by post. All participants will be asked to complete a paper PRO questionnaire at the start of the study and a separate paper survey on their satisfaction at using electronic or paper questionnaires 14 months after they join.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
21/WM/0223
Date of REC Opinion
15 Oct 2021
REC opinion
Further Information Favourable Opinion