Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience (PROMISE)–protocol for a randomised controlled trial of electronic self-reporting of symptoms versus usual care during and following treatment in patients with cancer

Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience (PROMISE)–protocol for a randomised controlled trial of electronic self-reporting of symptoms versus usual care during and following treatment in patients with cancer

Routine collection of patient-reported outcome measures (PROMs) has the potential to inform and improve cancer care. It is now feasible for patients to complete PROMs electronically (ePROMs) providing information about their current levels of symptoms, side effects of treatment and other concerns. P...

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Published in:BMJ open Vol. 14; no. 11; p. e090836
Main Authors: Webb, Penelope M, Brown, Amy, Brown, Bena, Collins, Louisa G, Crawford Williams, Fiona, Doupain, Kerrie, Eastgate, Melissa, Fennelly, Vicki, Girgis, Afaf, Hartel, Gunter, Ladwa, Rahul, Martin, Karen, Mason, Robert, McGuire, Peter, Miller, Elizabeth, O’Brien, Suzanne, Packer, Rebecca, Pinkham, Mark B, Sabesan, Sabe, Sanmugarajah, Jasotha, Slapp, Georgia, Tapsall, Doreen, White, Jeanie, Wishart, Laurelie R, Wyld, David, Chan, Raymond J
Format: Journal Article
Language:English
Published: BMA House, Tavistock Square, London, WC1H 9JR BMJ Publishing Group 19-11-2024
Subjects:
Oncology
Protocol
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Summary:Routine collection of patient-reported outcome measures (PROMs) has the potential to inform and improve cancer care. It is now feasible for patients to complete PROMs electronically (ePROMs) providing information about their current levels of symptoms, side effects of treatment and other concerns. PROM scores can be tracked over time allowing more timely identification of problems and more appropriate intervention. Studies have reported clear benefits in patient-clinician communication when PROMs are used and trials in the USA and France found patients randomised to complete regular ePROMs reported better health-related quality of life, had fewer unplanned hospital visits and, importantly, significantly better survival than those randomised to usual care. However, information about the effects on health outcomes and, particularly, the cost-effectiveness of incorporating this information into practice is limited.INTRODUCTIONRoutine collection of patient-reported outcome measures (PROMs) has the potential to inform and improve cancer care. It is now feasible for patients to complete PROMs electronically (ePROMs) providing information about their current levels of symptoms, side effects of treatment and other concerns. PROM scores can be tracked over time allowing more timely identification of problems and more appropriate intervention. Studies have reported clear benefits in patient-clinician communication when PROMs are used and trials in the USA and France found patients randomised to complete regular ePROMs reported better health-related quality of life, had fewer unplanned hospital visits and, importantly, significantly better survival than those randomised to usual care. However, information about the effects on health outcomes and, particularly, the cost-effectiveness of incorporating this information into practice is limited.PROMISE (Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience) is a multicentre, randomised hybrid effectiveness/implementation trial to evaluate the clinical and cost-effectiveness of using ePROMs in routine cancer care to improve patient outcomes. Participants (target sample=572; randomised 1:1 to intervention and control) are adults aged 18 years or older diagnosed with a solid cancer and starting treatment at one of the four study hospitals. The primary outcomes are unplanned hospital presentations and physical/functional well-being at 6 months. We hypothesise that, compared with usual care, patients randomised to use an ePROM tool will have fewer unplanned hospital presentations, report better health-related quality of life and greater satisfaction with their care and that the ePROM tool will be cost-effective. We will also assess implementation and process outcomes consistent with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) Framework.METHODS AND ANALYSISPROMISE (Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience) is a multicentre, randomised hybrid effectiveness/implementation trial to evaluate the clinical and cost-effectiveness of using ePROMs in routine cancer care to improve patient outcomes. Participants (target sample=572; randomised 1:1 to intervention and control) are adults aged 18 years or older diagnosed with a solid cancer and starting treatment at one of the four study hospitals. The primary outcomes are unplanned hospital presentations and physical/functional well-being at 6 months. We hypothesise that, compared with usual care, patients randomised to use an ePROM tool will have fewer unplanned hospital presentations, report better health-related quality of life and greater satisfaction with their care and that the ePROM tool will be cost-effective. We will also assess implementation and process outcomes consistent with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) Framework.This trial has been approved by the Metro South Human Research Ethics Committee (HREC/2020/QMS/67441). Participants provide written informed consent, including consent for record linkage, prior to completing the baseline questionnaire. Study results will be disseminated via peer-reviewed journals and presentations at scientific conferences and clinical meetings.ETHICS AND DISSEMINATIONThis trial has been approved by the Metro South Human Research Ethics Committee (HREC/2020/QMS/67441). Participants provide written informed consent, including consent for record linkage, prior to completing the baseline questionnaire. Study results will be disseminated via peer-reviewed journals and presentations at scientific conferences and clinical meetings.ACTRN12620001290987.TRIAL REGISTRATION NUMBERACTRN12620001290987.
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PMW has received a speaker’s fee from AstraZeneca (December, 2021). ME and DW were part of the Metro North Health team that developed AboutMe and BB and LRW were part of the PAH team that developed My Health My Way but neither tool has been commercialised and none of the authors have any financial interests in the tools. RL has received grant funding from MSD for an unrelated study and sits on Advisory Boards for/has received honoraria and travel funding from MSD, L’Oreal and Sanofi. BB has been a member of the Metro South Human Research Ethics Committee since 2018 but was not involved in the review of this study.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2024-090836