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

28 settembre 2021 aggiornato da: Galina Velikova, University of Leeds

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences: Implement the System for Remote Monitoring of Cancer Patients in Remission

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

143

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • West Yorkshire
      • Leeds, West Yorkshire, Regno Unito, LS97TF
        • St James University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
Dispositivo: ePRIME
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of patients recruited / Number of patients approached (=consent rate)
Lasso di tempo: Baseline
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
Lasso di tempo: 12 months
Number of participant withdrawals will be logged by research team at the time of any withdrawals
12 months
Reasons for participant withdrawals
Lasso di tempo: 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
12 months
Number of participants with self-reported symptom data (questionnaire) at 3 months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
Patients will be reminded to complete an electronic questionnaire about their symptoms at 12 months
12 months
Patient acceptability (questionnaire/interviews)
Lasso di tempo: 12 months
Patient acceptability explored through end-of-study questionnaires and interviews
12 months
Clinician acceptability (questionnaire/interviews)
Lasso di tempo: 12 months
Clinician acceptability explored through end-of-study questionnaires and interviews
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Leeds

Collaboratori

The Leeds Teaching Hospitals NHS Trust
Yorkshire Cancer Research
Airedale NHS Foundation Trust
Bradford Teaching Hospitals NHS Foundation Trust
Calderdale and Huddersfield NHS Foundation Trust

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2016

Completamento primario (Effettivo)

31 gennaio 2020

Completamento dello studio (Effettivo)

31 agosto 2021

Date di iscrizione allo studio

Primo inviato

19 maggio 2016

Primo inviato che soddisfa i criteri di controllo qualità

25 luglio 2016

Primo Inserito (Stima)

28 luglio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 settembre 2021

Ultimo verificato

1 settembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • L392 (gynae)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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