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SPRUCE: A study within a trial (SWAT) of electronic versus paper-based patient reported outcomes collection

In follow-up

Host Trials: PACE-C, PIVOTALboost, PACE-NODES

What is the study about?

SPRUCE is investigating different ways of collecting questionnaires from our trial participants.

People taking part in clinical trials are often asked to complete questionnaires to find out about their experiences of symptoms, side effects and their quality of life.

These questionnaires have traditionally been completed by our trial participants on paper, either in hospital clinics or sent to them by post.

SPRUCE aims to find out if offering people the option for completing questionnaires electronically would have any impact on how many questionnaires are completed and the sort of information that people report.

 

People who have agreed to take part in some of our clinical trials, including PACE-C, PIVOTALboost and PACE-NODES, will be invited to join SPRUCE by their local hospital team.

We planned to invite 366 people to join the study from NHS hospitals in the UK. A total of 414 people agreed to take part. 248 participants agreed to be randomly assigned a questionnaire method, while 166 chose their preferred method.

People who agreed to join SPRUCE were asked whether they would be willing to have the type of questionnaire they complete decided randomly, rather than selecting it themselves. If they agreed to have the type of questionnaire selected randomly, they had either:

  • Paper questionnaires, with booklets posted to their home addresses

OR

  • Electronic questionnaires, with links to a webpage sent by email

If people were not willing to have the type of questionnaire selected randomly but still wanted to join the study, they could select their preferred questionnaire format.

Participants were also asked to complete a demographics questionnaire and a satisfaction survey after their last questionnaire.

Further information for participants

Patient Information Sheet

Further information for healthcare professionals

Protocol

Chief Investigator: Rebecca Lewis, The Institute of Cancer Research

ICR-CTSU Scientific Lead:  Professor Emma Hall

Trial management contact: [email protected]

Sponsor: The Institute of Cancer Research

REC reference: 21/WM/0223

CPMS ID: 50553

Philipps, Lara; Haviland, Joanne; Stiles, Morgaine; Maudsley, Jessica; Syndikus, Isabel; Tree, Alison; Harland, Keith; Ridley, Paul; Gath, Jacqui; Huddart, Robert; Hall, Emma; Lewis, Rebecca. (2025) ‘Study within a trial of electronic versus paper-based Patient Reported oUtcomes CollEction (SPRUCE) - primary outcome and patient demographics’. Oral presentation for 46th Society for Clinical Trials 2025.

Philipps L, Foster S, Gardiner D, Gath J, Gillman A, Haviland J, Hill E, King D, Manning G, Stiles M, Hall E, Lewis R. Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE): study protocol for a partially randomised patient preference study. BMJ Open. 2023 Sep 21;13(9):e073817. doi: 10.1136/bmjopen-2023-073817. PMID: 37734892; PMCID: PMC10514621.

Philipps L, Foster S, Gardiner D, Gillman A, Haviland J, Hill E, Manning G, Stiles M, Hall E, Lewis R. Considerations when introducing electronic patient-reported outcome data capture in multicentre oncology randomised controlled trials. Trials. 2022 Dec 12;23(1):1004. doi: 10.1186/s13063-022-06955-w. PMID: 36510242; PMCID: PMC9744038.

Manning G, Stiles M, Foster S, Gillman A, Haviland J, Hill E, King D, Lloyd L,  Newman O, Omar A, Philipps L, Hall E, Lewis R. (2022) ‘Patient and public involvement (PPI) in a study within a trial (SWAT) investigating electronic patient reported outcomes (ePRO) within clinical trials – the SPRUCE study’. Poster presentation for 6th International Clinical Trials Methodology Conference October 2022.