A Study within a trial of electronic versus paper based Patient Reported oUtcomes CollEction (SPRUCE).


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Lara Philipps1, Morgaine Stiles1, Georgina Manning1, Abdullahi Omar1, Lisa Lloyd1, Jo Haviland1, Alexa Gillman1, Emma Hall1, Rebecca Lewis1
1Institute of Cancer Research (ICR)

Abstract

Background

The patient perspective and survivorship effects are crucial factors to consider in evaluating new oncology treatments. Validated questionnaires of patient reported outcomes (PRO) can be used to collect information directly from patients on the impact that treatment and health conditions have on quality of life.

 

Although studies in the clinical setting have assessed the validity of using electronic PRO (ePRO), there is limited published literature demonstrating the equivalence to paper PROs in clinical trials.

 

A survey designed in collaboration with patient representatives to assess public opinion on the completion of electronic healthcare questionnaires is underway, with a focus group to follow.

 

With patient and public input, a study within a trial (SPRUCE) will pilot implementation of ePRO collection within multi-centre randomised trials at an NCRI Cancer Clinical Trials Unit. 

 

Method

SPRUCE will investigate use of ePRO and paper PRO within a number of multi-centre randomised host trials. SPRUCE has a partially randomised patient preference design to ensure that “real-world” data is collected and to prevent patients being excluded due to lack of internet or IT technology access.  

 

244 participants consenting to be randomised will be allocated to either electronic or paper PROs (1:1) using a minimisation algorithm. If they are unwilling to be randomised they will be allocated their preference. All participants will complete baseline PRO on paper and will receive follow up questionnaires either electronically or on paper by post.  Questionnaires will be distributed at host trial protocol-specified time points up to 12 months. All participants will receive a paper questionnaire asking about their experience of their allocated modality of PRO completion 14 months post-enrolment.

 

The primary endpoint is patient compliance, defined as the percentage of patients returning a completed ePRO questionnaire compared with paper PRO at the host trial’s first post-intervention PRO time point. Secondary endpoints will include analysis of completeness of data and changes in response scores from baseline.

 

Results

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Conclusion

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Impact statement

ePRO collection could significantly improve the patient experience within clinical trials. Our work aims to collect real world evidence on the acceptability and usability of ePROs within the oncology clinical trial setting.