# Patient and public involvement in the SPRUCE methodology study investigating electronic patient reported outcomes in oncology clinical trials

## TL;DR

The SPRUCE study involves patients and the public to assess electronic questionnaires in cancer clinical trials, aiming to improve participant experience and data collection.

## Contribution

The study introduces a novel approach to integrating patient and public involvement in the design and oversight of electronic patient-reported outcome systems in oncology trials.

## Key findings

- Most survey respondents were open to completing healthcare questionnaires electronically.
- PPI input led to changes in the ePRO system, including adding a free text box for comments.
- Patient and public involvement improved the acceptability and usability of the SPRUCE study design.

## Abstract

Patient reported outcomes (PRO) provide crucial insight into trial participants’ experience of oncology treatments. At the Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), these are completed by participants on paper. The SPRUCE study within a trial (SWAT) investigates the impact of PRO questionnaire modality (paper or electronic) on the data received. To ensure SPRUCE is acceptable and appropriately patient-focused, we involved Patient and Public Involvement (PPI) partners throughout development and oversight.

A survey was developed with PPI input, to assess public attitudes to electronic completion of healthcare questionnaires. We advertised in local papers to reach respondents without internet access; other avenues were limited due to the COVID-19 pandemic. Survey respondents were invited to virtual discussion groups to review the proposed SWAT design and provide feedback on its relevance and acceptability to potential study participants. Discussion group contributors were invited to join the SPRUCE Patient and Public Oversight Committee, providing PPI input throughout the study. Committee members were given a document explaining clinical trials, the SPRUCE study, and the committee itself. The first committee meeting saw PPI members testing the electronic PRO (ePRO) system and giving feedback on this and the patient-facing documents, for which we provided structured feedback forms. Members also provided feedback on the meeting itself. Of the fifty survey respondents, eight joined a discussion group. Six subsequently joined the Patient and Public Oversight Committee, along with one patient advocate who had been involved in the initial study design and funding application. Each committee member had access to the internet and would prefer to complete PRO questionnaires electronically. Six committee members tested the online ePRO completion system using various personal devices, resulting in changes including the addition of a free text box for participants to leave comments. Patient and public input also shaped patient-facing study documentation, including wording of the patient information sheet and correspondence to participants.

Despite challenges faced in accessing a diverse demographic, PPI input has improved SPRUCE by ensuring the patient viewpoint is central to study oversight, helping identify ways to improve participant experience and streamlining study processes.

The online version contains supplementary material available at 10.1186/s40900-025-00742-y.

People taking part in clinical trials are often asked to complete questionnaires about treatment side-effects. In trials run by our unit, we usually ask people to complete these on paper, however it is now possible for questionnaires to be completed electronically over the internet. We designed a study, SPRUCE, to look at acceptability of electronic questionnaires, and whether they are as likely to be returned electronically as on paper. Patients and members of the public help to make sure research is acceptable and patient-focused. It has been particularly important to involve patient advisors in SPRUCE, because it looks at a new way of collecting information from people. Before starting SPRUCE, we surveyed the public about completing healthcare questionnaires electronically, and their experience of computer technology. Most people who completed our survey were happy to complete questionnaires electronically. We asked people who completed our survey to take part in discussion groups to give feedback on the final design of SPRUCE. A Patient and Public Oversight Committee was formed from people who took part in the discussion groups. The committee helped to test the system for sending electronic questionnaires, gave advice on the information SPRUCE participants would need, and reviewed wording to make sure the electronic system and all documents were easy to use and understand. They also helped develop surveys to find out more about the background of participants and their experience of completing questionnaires, and a letter to update participants when the planned number of people had joined SPRUCE.

The online version contains supplementary material available at 10.1186/s40900-025-00742-y.