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| Name | Class |
|---|---|
| Yorkshire Cancer Research | OTHER |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| Bradford Teaching Hospitals NHS Foundation Trust | OTHER_GOV |
| Calderdale and Huddersfield NHS Foundation Trust |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audit phase | No Intervention | 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. | |
| Intervention (pilot-phase) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePRIME | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participant withdrawals | Number of participant withdrawals will be logged by research team at the time of any withdrawals | 12 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of participants with self-reported symptom data (questionnaire) at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galina Velikova | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St James University Hospital | Leeds | West Yorkshire | LS97TF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36512093 | Derived | Kennedy F, Shearsmith L, Holmes M, Velikova G. 'It made me feel part of the team, having my homework to do' - women and specialist nurse experiences of remote follow-up after ovarian cancer treatment: a qualitative interview study. Support Care Cancer. 2022 Dec 13;31(1):2. doi: 10.1007/s00520-022-07470-z. | |
| 35780095 | Derived |
| Label | URL |
|---|---|
| Research group website/webpage relating to the study | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| OTHER |
| Airedale NHS Foundation Trust | OTHER |
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Patients will be reminded to complete an electronic questionnaire about their symptoms at 12 months |
| 12 months |
| Patient acceptability (questionnaire/interviews) | Patient acceptability explored through end-of-study questionnaires and interviews | 12 months |
| Clinician acceptability (questionnaire/interviews) | Clinician acceptability explored through end-of-study questionnaires and interviews | 12 months |
| Kennedy F, Shearsmith L, Holmes M, Rogers Z, Carter R, Hofmann U, Velikova G. Electronic patient-reported monitoring of symptoms during follow-up of ovarian cancer patients: a feasibility study. BMC Cancer. 2022 Jul 2;22(1):726. doi: 10.1186/s12885-022-09817-5. |