ePRIME: Patient-Reported AEs in Early Phase Trials

NCT03461939 | Completed

• 1 other identifier: L392 (EPT)
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

New treatments are continually being developed to help patients living with advanced cancer, which require extensive clinical trials before authorisation for standard clinical use. Reporting of adverse events (AE) in this setting is essential to ensure treatment safety and tolerability. The current system for reporting AEs, the Common Toxicity Criteria and Adverse Events (CTCAE) relies on the clinician's interpretation of patient symptoms, but a substantial body of evidence suggests clinicians miss/underestimate AEs experienced by patients. The aim of the overall project is to explore the implementation of an electronic patient-reported outcomes (ePRO) system to gather adverse events data in early phase clinical trials (EPCT) patients. In Phase 1 of this study, through semi-structured interviews, we explored patient, healthcare, and clinical trial staffs' views about collecting electronic patient-reported outcomes in this setting. This work informed the direction of the current pilot. This proof-of-principle feasibility study will explore the feasibility and satisfaction with using an electronic system to remotely self-report AEs whilst on EPCT. The key objectives are to:

1. 1.Evaluate the feasibility of using a secure online method (ePRIME system) to collect PRO-AEs in EPCT patients.
2. 2.Explore patient satisfaction with the use of the ePRIME system to collect PRO AEs in EPCT patients.
3. 3.Monitor the number of notifications for severe AEs generated by the system to address concerns from the interviews that ePROs will lead to increased workload.

Conditions

Cancer

Keywords

ePRIME; PRO; PROM; Adverse event; QTool; Early phase; CTCAE

Outcome Measures

Primary Outcomes (1)

• Feasibility of using a secure, online system to record, monitor, and help patients report AEs.

  Feasibility of using a secure, online system to record, monitor, and help patients report AEs. It will be measured through: * the number of participants consenting versus declining; * compliance with the ePRIME trial through the number of missed completions, out of the 12 weeks (minimum) prompted by the research team; * number and timing of participant withdrawals and reasons; * number of completions in addition to the weekly prompts; * number of completions that generate notifications to the early phase clinical trials ePRIME email address.

  2018-2020

Secondary Outcomes (1)

• Participant satisfaction with using the system

  2018-2020

Study Arms (1)

ePRIME

Participants in the study will receive training in using the ePRIME system to report their symptoms and side effects on a weekly basis from home via the internet for 12 weeks while receiving early phase trial treatment. Patients will be sent email/text reminders to enter their symptoms on the system once a week. Patients will be reminded that the data they enter via the online system will not be reviewed promptly by their hospital team and therefore they should continue to contact their treatment team via the contact numbers they have been given. As part of the research project, we will monitor the number of notifications for severe AE generated by the system to address concerns from the interviews conducted in the first phase of this research project that ePROs will lead to increased workload for clinicians.

Other: ePRIME symptom monitoring tool

Interventions

ePRIME symptom monitoring tool OTHER

ePRIME is an online system for patients to self-report symptoms and AE during cancer treatment. ePRIME allows AE reporting from home or hospital and enables patient reported data to be integrated into existing EPR to allow for the reports to be used in routine care. In addition the system is capable of generating notifications for severe AE to the relevant clinical team and providing patient advice on managing mild and moderate AE.

ePRIME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled and receiving treatment on a early phase clinical trial.

You may qualify if:

• Cancer patients enrolled in an academic Phase I or Phase II EPCT;
• Patients receiving novel anticancer agents, including but not limited to novel agents, such as chemotherapy, targeted agents, or chemo-radiotherapy, chemo-immunotherapy ;
• Within 1 month of having started treatment on an early phase clinical trial;
• Able and willing to give informed consent;
• Able to read and understand English;
• Access to internet via a computer, laptop, tablet or mobile phone;
• Aged ≥ 18.

You may not qualify if:

• Patients involved in an EPCT involving surgery or radiotherapy alone;
• Patients involved in commercial EPCTs
• Patients who will be on an early phase clinical trial for less than 3 months;
• Evidence of overt psychopathology or serious cognitive dysfunction which would impede study participation.

Sponsors & Collaborators

• University of Leeds: lead
• Yorkshire Cancer Research: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Weston Park Hospital

Sheffield, United Kingdom

Location

Related Publications (1)

• Shearsmith L, Danson S, Gelcich S, Gibson A, Gordon K, Collinson F, Croft J, Griffiths E, Rogers Z, Carter R, Brown J, Velikova G, Kennedy F. Electronic patient-reported adverse event monitoring in academic early-phase clinical trials: A feasibility study. Clin Trials. 2025 Oct 27:17407745251378668. doi: 10.1177/17407745251378668. Online ahead of print.

  PMID: 41140127 DERIVED

Related Links

• Research group website/webpage relating to the study

MeSH Terms

Conditions

Neoplasms

Study Officials

• Galina Velikova

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psycho-social and Medical Oncology/Consultant in Medical Oncology

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 12, 2018
• Study Start: August 9, 2018
• Primary Completion: July 30, 2021
• Study Completion: August 31, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)