Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences (ePRIME)
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|ClinicalTrials.gov Identifier: NCT02847715|
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Device: ePRIME||Not Applicable|
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.
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.
- Develop a new electronic care pathway/system for remote monitoring patients in remission
- Obtain initial data on clinical and patient feasibility.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||July 2020|
No Intervention: Audit phase
In the audit-phase, a group of 59 patients will be recruited and followed over a 12 month period. Data will be collected on clinical and patient outcomes in an audit in order to be able to compare to the intervention (after-phase) group.
Experimental: Intervention (pilot-phase)
In the pilot-phase, a group of 59 patients will be recruited and followed over a 6-12 month period. Patients in this group will be assigned to the new remote monitoring follow-up pathway (ePRIME), whereby instead of attending routine outpatient appointments they are monitored remoted via a online symptom monitoring questionnaire and related clinical tests undertaken remotely. All information is collated in the patient's electronic patient record, and clinicians will review/respond to the data as necessary.
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.
- Number of patients recruited / Number of patients approached (=consent rate) [ Time Frame: Baseline ]Number of patients recruited and number of patients approached will be logged by research team during recruitment (including reasons for non-recruitment)
- Number of participant withdrawals [ Time Frame: 12 months ]Number of participant withdrawals will be logged by research team at the time of any withdrawals
- Reasons for participant withdrawals [ Time Frame: 12 months ]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
- Number of participants with self-reported symptom data (questionnaire) at 3 months [ Time Frame: 3 months ]Patients will be reminded to complete an electronic questionnaire about their symptoms at 3 months
- Number of participants with self-reported symptom data (questionnaire) at 6 months [ Time Frame: 6 months ]Patients will be reminded to complete an electronic questionnaire about their symptoms at 6 months
- Number of participants with self-reported symptom data (questionnaire) at 9 months [ Time Frame: 9 months ]Patients will be reminded to complete an electronic questionnaire about their symptoms at 9 months
- Number of participants with self-reported symptom data (questionnaire) at 12 months [ Time Frame: 12 months ]Patients will be reminded to complete an electronic questionnaire about their symptoms at 12 months
- Patient acceptability (questionnaire/interviews) [ Time Frame: 12 months ]Patient acceptability explored through end-of-study questionnaires and interviews
- Clinician acceptability (questionnaire/interviews) [ Time Frame: 12 months ]Clinician acceptability explored through end-of-study questionnaires and interviews
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847715
|Contact: Galina Velikovaemail@example.com|
|Contact: Fiona Kennedyfirstname.lastname@example.org|
|St James University Hospital||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS97TF|
|Contact: Fiona Kennedy 0113 2068952 ext 68952 F.R.Kennedy@leeds.ac.uk|
|Principal Investigator:||Galina Velikova||University of Leeds|