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

Enrolling participants

Host Trials: PACE-CPIVOTALboost, 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.

Who is included in the study?

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. Around 366 people will join the study from NHS hospitals in the UK.

What does the study involve?

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

  • Paper questionnaires, with booklets posted to their home addresses

OR

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

If people are not willing to have the type of questionnaire selected randomly but would still like to join the study, they can select their preferred questionnaire format.

Participants will also be 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

Contact details and regulatory information

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

Trial identifiers

REC reference: 21/WM/0223

CPMS ID: 50553

Publications and presentations

Philipps L, Stiles M, Manning G, Omar A, Lloyd L, Haviland J, Gillman, A, Hall E, Lewis R, A Study within a trial (SWAT) of electronic versus paper-based Patient Reported oUtcomes CollEction, National Cancer Research Institute Cancer Conference, Nov 2021

Philipps L, Haviland J, Gillman, A, Hall E, Lewis R, Study within a trial comparing electronic versus paper patient reported outcome collection. Presented at: Society of Clinical Trials

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.