Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences

Cancer Clinical Trial

— ePRIME  

Official title:

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences: Implement the System for Remote Monitoring of Cancer Patients in Remission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847715
• Other study ID #: L392 (gynae)
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Improvements in cancer treatment have led to an increasing number of patients being cured or in remission, but they are followed up to detect recurrence, manage persistent symptoms and late treatment effects. With growing survivors, traditional hospital follow-up is not sustainable. New models of follow-up care are needed. This research project aims to develop and establish the feasibility of introducing a new electronic care pathway/system for remote monitoring ovarian cancer patients in remission. The project includes a development phase, followed by an audit & pilot intervention phase to explore the feasibility of a new pathway/system for remote monitoring.

Description:

Background Improvements in cancer treatment have led to an increasing number of patients being cured or in remission, but they are followed up to detect recurrence, manage persistent symptoms and late treatment effects. With growing survivors, traditional hospital follow-up is not sustainable. New models of follow-up care are needed.

Aim To develop and establish the feasibility of introducing a new electronic care pathway/system for remote monitoring ovarian cancer patients in remission.

Methods An existing online patient symptom reporting system will be extended for use in remote follow-up. A tracking program will be developed and IT systems integrated in the local hospitals.

Development Phase:

a) Scoping literature review of existing validated symptom measures. b) Consultation with expert groups to establish choice of questions, relevant symptoms, timing/frequency for monitoring. c) Interviews with patients and clinicians to explore current pathway and redesign.

Audit of usual care phase In this phase consecutive eligible ovarian, fallopian tube, primary peritoneal, endometrial or female genital (not otherwise specified) cancer patients (on completion of their first/second line of treatment) will be approached and data on clinical outcomes collected at the routine 3 monthly outpatient appointments for 12 months and PROMs collected 6 monthly. We aim to recruit around 60 patients.

Pilot Intervention phase In the intervention group the feasibility of the re-designed care pathway (intervention) will be piloted in a separate group of eligible ovarian, fallopian tube, primary peritoneal, endometrial or female genital (not otherwise specified) cancer patients. The patients approached will be a mixture of those who are entering follow-up after recently completing their first/second line treatment, and those who have already been attending for some time (months/years) for routine follow-up after their first/second line treatment. We aim to recruit around 60 patients. Consenting patients will be reminded to use the online system every 3 months and have a mandatory blood test by their GP/local hospital. Information will be available for the clinical teams to access electronically. Patients will always have the option to choose to speak or see their 'key clinician'. Virtual clinics will be held for key clinicians to review and respond to remote monitoring data. Clinical and patient outcomes will be collected for a 6-12 month period (this timeframe is dependent on the date of study entry and the funding period remaining). Following the pilot intervention period, 10 patients (or more if deemed necessary) and 6 clinicians will also be interviewed.

Outcomes

• Develop a new electronic care pathway/system for remote monitoring patients in remission

• Obtain initial data on clinical and patient feasibility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: August 31, 2021
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (aged 18 years or over) attending St James' University Hospital Bexley Wing, Bradford Teaching Hospitals NHS Foundation Trust, Calderdale & Huddersfield NHS Foundation Trust, and Airedale NHS Foundation Trust with stage 2-4 ovarian/fallopian/peritoneal/endometrial cancer in remission following the end of first or second line chemotherapy or end of maintenance Avastin/Bevacizumab (where indicated)

• Patients may have recently completed treatment or already been on routine clinic-based face-to-face follow-up at the time of recruitment into the pilot intervention phase

• Able and willing to give informed consent

• Able to read and understand English

• Access to the internet

Exclusion Criteria:

• Exhibiting overt psychopathology/cognitive dysfunction

• Taking part in other clinical trials involving the completion of extensive patient reported outcome or quality of life measures or requiring scheduled face-to-face clinical outpatient appointments (Intervention group only)

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• ePRIME
ePRIME is an remote monitoring pathway that includes an online system for patients to self-report symptoms and AE following cancer treatments. ePRIME allows AE reporting from home 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 alerts for serious symptoms to the relevant clinical team and providing patient advice on managing mild and moderate symptoms.

Locations

Country	Name	City	State
United Kingdom	St James University Hospital	Leeds	West Yorkshire

Sponsors (6)

Lead Sponsor	Collaborator
University of Leeds	Airedale NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, Calderdale and Huddersfield NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Yorkshire Cancer Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients recruited / Number of patients approached (=consent rate)	Number of patients recruited and number of patients approached will be logged by research team during recruitment (including reasons for non-recruitment)	Baseline
Primary	Number of participant withdrawals	Number of participant withdrawals will be logged by research team at the time of any withdrawals	12 months
Primary	Reasons for participant withdrawals	Reasons for withdrawal will be assessed via case record form completed by researcher with the participant at time of withdrawal and collated at the end of the study	12 months
Primary	Number of participants with self-reported symptom data (questionnaire) at 3 months	Patients will be reminded to complete an electronic questionnaire about their symptoms at 3 months	3 months
Primary	Number of participants with self-reported symptom data (questionnaire) at 6 months	Patients will be reminded to complete an electronic questionnaire about their symptoms at 6 months	6 months
Primary	Number of participants with self-reported symptom data (questionnaire) at 9 months	Patients will be reminded to complete an electronic questionnaire about their symptoms at 9 months	9 months
Primary	Number of participants with self-reported symptom data (questionnaire) at 12 months	Patients will be reminded to complete an electronic questionnaire about their symptoms at 12 months	12 months
Primary	Patient acceptability (questionnaire/interviews)	Patient acceptability explored through end-of-study questionnaires and interviews	12 months
Primary	Clinician acceptability (questionnaire/interviews)	Clinician acceptability explored through end-of-study questionnaires and interviews	12 months

External Links

•   Research group website/webpage relating to the study