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

NCT02847715 | Completed

• 1 other identifier: L392 (gynae)
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

PRO; PROM; Adverse event; QTool; Aftercare

Outcome Measures

Primary Outcomes (9)

• 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

  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

Study Arms (2)

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.

Device: ePRIME

Interventions

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.

Intervention (pilot-phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Leeds: lead
• Yorkshire Cancer Research: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Bradford Teaching Hospitals NHS Foundation Trust: collaborator
• Calderdale and Huddersfield NHS Foundation Trust: collaborator
• Airedale NHS Foundation Trust: collaborator

Study Sites (1)

St James University Hospital

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 36512093 DERIVED

• 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.

  PMID: 35780095 DERIVED

Related Links

• Research group website/webpage relating to the study

MeSH Terms

Conditions

Neoplasms

Study Officials

• Galina Velikova

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psycho-social and Medical Oncology/Consultant in Medical Oncology

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion: January 31, 2020
• Study Completion: August 31, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)