Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences: Implement the System for Remote Monitoring of Cancer Patients in Remission
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Leeds
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Number of patients recruited / Number of patients approached (=consent rate)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
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.
Intervention: ePRIME (Device)
Outcomes
Primary Outcomes
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 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 9 months
Time Frame: 9 months
Patients will be reminded to complete an electronic questionnaire about their symptoms at 9 months
Clinician acceptability (questionnaire/interviews)
Time Frame: 12 months
Clinician acceptability explored through end-of-study questionnaires and interviews
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
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 12 months
Time Frame: 12 months
Patients will be reminded to complete an electronic questionnaire about their symptoms at 12 months
Number of participant withdrawals
Time Frame: 12 months
Number of participant withdrawals will be logged by research team at the time of any withdrawals
Patient acceptability (questionnaire/interviews)
Time Frame: 12 months
Patient acceptability explored through end-of-study questionnaires and interviews
Secondary Outcomes
No secondary outcomes reported
Investigators
Galina Velikova
Professor of Psycho-social and Medical Oncology/Consultant in Medical Oncology
University of Leeds