Pilot randomized 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/Objective(s): 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 randomized feasibility/
pilot study aimed to establish feasibility, recruitment/attrition rates, select a
primary outcome measure for a future randomized controlled trial (RCT)
and refine the intervention.
Materials/Methods: A prospective two-center randomized (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
gynecological cancers. Participants randomized to eRAPID reported AE
from home weekly for 12 weeks, and then at 18 &24 weeks. We measured
and analyzed descriptively: Patient-reported outcomes (validated questionnaires:
FACT-G, EORTC-QLQ-C30), process of care (hospital records
of patient contacts/admissions); economic measures (EQ5D-5L). Semistructured
interviews were conducted with staff and patients with thematic
analysis. ClinicalTrials.gov NCT02747264.
Results: Between 2016 and 2018, 502 patients from two UK centers were
screened for eligibility, 253 approached and 228 found to be eligible, 167
consented (73.2%) and were randomized (83-eRAPID,84-UC); 87-prostate,
45-gynaecological, 34-lower gastrointestinal cancers. Withdrawals
were 16/167 Z 9.6% (10-eRAPID,6-UC). Patient compliance with online
self-reports was 82% of expected at week 1, 63% at week 12. Return rates
of outcome measures-95.8% 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 chemoradiotherapy
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 chemo-radiotherapy 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.
Affiliation
Description
Date
2020
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Henry A, Holch P, Routledge JA, Absolom K, Walker K, Gibson A, et al. Pilot randomized trial of online self-monitoring of symptoms during pelvic radiotherapy. International Journal of Radiation Oncology Biology Physics. 2020;108(3):E211-E2