| Study name |
eRAPID electronic patient self‐Reporting of Adverse‐events: Patient Information and aDvice: a pilot study protocol in pelvic radiotherapy |
| Methods |
Randomised trial, UK |
| Participants |
Patients attending St James ’ s University hospital cancer centre and The Christie Hospital Manchester undergoing pelvic radiotherapy+/ − chemotherapy/hormonotherapy for prostate, lower gastrointestinal and gynaecological cancers. |
| Interventions |
Prospective 1:1 randomised (intervention or usual care) parallel group design with repeated measures and mixed methods will be employed. Aim is to recruit 168 patients following recommendations for sample size estimates for pilot studies. Participants using eRAPID will report AE (at least weekly) from home weekly for 6 weeks and 6 weeks post‐treatment (12‐week total) then at 18 and 24 weeks.Hospital staff will review eRAPID reports and use information during consultations. Notifications will be sent to the relevant clinical team when severe symptoms are reported. |
| Outcomes |
The objectives are to establish feasibility, recruitment, integrity of the system and attrition rates, determine effect sizes and aid selection of the primary outcome measure for a future randomised trial. |
| Starting date |
September 2016 |
| Contact information |
Trish Holch, Department of Psychology, School of Social Sciences, Leeds Beckett University, Calverley Building, Room CL 815 City Campus, Leeds LS1 9HE, UK. Email: T.Holch@Leedsbeckett.ac.uk |
| Notes |
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