Clinical trial NCT02847715: Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: PRO
PROM
Adverse event
QTool
Aftercare
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Yorkshire Cancer Research
name: The Leeds Teaching Hospitals NHS Trust
name: Bradford Teaching Hospitals NHS Foundation Trust
name: Calderdale and Huddersfield NHS Foundation Trust
name: Airedale NHS Foundation Trust
First posted: 2016-07-28
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients recruited / Number of patients approached (=consent rate)
timeFrame: Baseline
measure: Number of participant withdrawals
timeFrame: 12 months
measure: Reasons for participant withdrawals
timeFrame: 12 months
measure: Number of participants with self-reported symptom data (questionnaire) at 3 months
timeFrame: 3 months
measure: Number of participants with self-reported symptom data (questionnaire) at 6 months
timeFrame: 6 months
measure: Number of participants with self-reported symptom data (questionnaire) at 9 months
timeFrame: 9 months
measure: Number of participants with self-reported symptom data (questionnaire) at 12 months
timeFrame: 12 months
measure: Patient acceptability (questionnaire/interviews)
timeFrame: 12 months
measure: Clinician acceptability (questionnaire/interviews)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St James University Hospital
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Galina Velikova
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.