ePRIME: Patient-Reported AEs in Early Phase Trials

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences (ePRIME): Collection of Patient-reported Adverse Events in Early Phase Clinical Trials in Yorkshire

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. Evaluate the feasibility of using a secure online method (ePRIME system) to collect PRO-AEs in EPCT patients.
2. Explore patient satisfaction with the use of the ePRIME system to collect PRO AEs in EPCT patients.
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.

To this end, a prospective longitudinal pilot will be conducted of the ePRIME system in early phase clinical trial patients in Leeds and Sheffield. A convenience sample of patients enrolled in Phase I or Phase II trials will be recruited. Patients in general oncology and haematology clinics will be included if diagnosed with metastatic or progressive disease and are presently receiving novel agents in an academic early phase clinical trial, such as chemotherapy, targeted agents, or chemo-radiotherapy. Patients will be included in this pilot whether the trial is a test of a novel drug, drug combination, or dose escalation. The study will aim to identify, approach, and consent all eligible patients over a minimum of a 12 month period. If they are over 18, able to give informed consent, have access to internet via any device, and able to read and understand English. Patients will be approached and consented within 1 month of having been entered in the clinical trial. Patients will not be eligible if they will be on the clinical trial for less than 3 months. Each patient will complete a patient-reported AE checklist at baseline (i.e. time of consent) and then weekly for 12 weeks. At the end of the 12 weeks an end-of-study interview will be conducted to explore patient satisfaction with the system. It is envisaged that this project will provide initial information on the feasibility and acceptability of a novel electronic system to facilitate the collection of patient-reported AEs in early phase trials.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: ePRIME symptom monitoring tool

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • Weston Park Hospital
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction with using the system	We will explore participant satisfaction with the use of the system. Through an end-of-study interview with patients and healthcare professionals we will explore the perceived burden, barriers, and opportunities and benefits of using the novel system. In addition to this, we will also explore system usability parameters such as time of log-on and log-off, time taken to complete the measures, time outs, and time spent on each page/section.	2018-2020

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: The Leeds Teaching Hospitals NHS Trust; Sheffield Teaching Hospitals NHS Foundation Trust; Yorkshire Cancer Research

Publications and helpful links

Helpful Links

• Research group website/webpage relating to the study

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ePRIME; PRO; PROM; Adverse event; QTool; Early phase; CTCAE
• Other Study ID Numbers: L392 (EPT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No