Pilot randomised trial of online self-monitoring of symptoms during pelvic radiotherapy
Henry, A. Holch, P. Routledge, Jacqueline A Absolom, K. Walker, K. Gibson, A. Carter, R. Brown, J Velikova, G.
Henry, A.
Holch, P.
Routledge, Jacqueline A
Absolom, K.
Walker, K.
Gibson, A.
Carter, R.
Brown, J
Velikova, G.
Citations
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Abstract
Purpose or Objective
Radiotherapy and chemo-radiotherapy for pelvic cancers
increases survival but has serious short and long-term
pelvic-related adverse effects (AEs). Active monitoring
and timely management of the acute AEs may improve
patient experiences. eRAPID (electronic patient self-
Reporting of Adverse-events: Patient Information and
aDvice) approach uses a secure online system for patients
to report AEs, providing either self-management
suggestions or advice for hospital contact. This randomised
feasibility/pilot study aimed to establish feasibility,
recruitment/attrition rates, select a primary outcome measure for a future randomised controlled trial (RCT) and
refine the intervention.
Material and Methods
A prospective two-centre randomised (1:1 intervention or
usual care (UC)) parallel group trial with repeated
measures and mixed methods. Eligible patients were
undergoing pelvic
radiotherapy+/−chemotherapy/hormone therapy for
prostate, lower gastrointestinal and gynaecological
cancers. Participants randomised to eRAPID reported AE
from home weekly for 12 weeks,18 &24 weeks. We
measured and analysed descriptively: Patient-reported
outcomes (validated questionnaires: FACT-G, EORTC-QLQC30),
process of care (hospital records of patient
contacts/admissions); economic measures (EQ5D-5L).
Semi-structured interviews were conducted with staff and
patients with thematic analysis.
Ethics approval Yorkshire &The Humber Leeds East
Research Ethics Committee (REC reference 16/YH/0371,
13.09.2016). ClinicalTrials.gov NCT02747264.
Results
Between Dec 2016-June 2018, 502 patients from Leeds
Cancer Centre and Christie Hospital,Manchester were
screened for eligibility, 228 were approached, 167
consented (73.2%) and were randomized (83-eRAPID,84-
UC); 87-prostate,45-gynaecological, 34-lower
gastrointestinal cancers. Withdrawals were 16/228=7%
(10-eRAPID,6-UC). Patient compliance with online selfreports
was 82% of expected at week 1, 63% at week 12.
Return rates of outcome measures-99.8% at baseline,77.8%
at 18 and 73.7% at 24 weeks. eRAPID patients reported less
deterioration over time (biggest difference at 6 weeks):
FACT-G mean change-score: eRAPID -2.9 (s.d.11.6); UC -
7.6 (s.d.10.5); QLQ-C30 summary-score change: eRAPID -
6.3 (s.d.11.8); -10.7 (s.d.13.8). The score changes were
larger in chemo-radiotherapy patients. Similar trends were
seen for EQ5D. The system was acceptable to patients and
staff. Clinicians recommended longer online monitoring.
Conclusion
This pilot RCT confirmed the intervention is acceptable and recruitment is feasible (consent rate of >70%,
withdrawal <10%; online completions 60-70%). Patient
outcome measures suggest potential benefit in the chemoradiotherapy
groups, but this needs confirmation in a
formally powered RCT.
This is independent research was funded by the UK
National Institute for Health Research (NIHR) under its
Programme Grants for Applied Research Programme
(reference number RP-PG-0611-20008). The views
expressed are those of the author(s) and not necessarily
those of the NHS, the NIHR or the Department of Health.
Description
Date
2020
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Henry A, Holch P, Routledge J, Absolom K, Walker K, Gibson A, et al. OC-0314: Pilot randomised trial of online self-monitoring of symptoms during pelvic radiotherapy. Radiotherapy and Oncology . 2020 Nov;152:S164–5.