Clinical trial NCT03461939: ePRIME: Patient-Reported AEs in Early Phase Trials
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: ePRIME
PRO
PROM
Adverse event
QTool
Early phase
CTCAE
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Yorkshire Cancer Research
name: The Leeds Teaching Hospitals NHS Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2018-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled and receiving treatment on a early phase clinical trial.

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of using a secure, online system to record, monitor, and help patients report AEs.
timeFrame: 2018-2020
Secondary outcomes:
measure: Participant satisfaction with using the system
timeFrame: 2018-2020
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
Study officials:
affiliation: University of Leeds
name: Galina Velikova
role: PRINCIPAL_INVESTIGATOR
References: