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
Introduction 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 othe...
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BMJ Publishing Group
2024-11-01
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| author | David Wyld Afaf Girgis Elizabeth Miller Penelope M Webb Gunter Hartel Karen Martin Rahul Ladwa Melissa Eastgate Suzanne O’Brien Sabe Sabesan Raymond J Chan Amy Brown Robert Mason Mark B Pinkham Bena Brown Louisa G Collins Fiona Crawford Williams Kerrie Doupain Vicki Fennelly Peter McGuire Rebecca Packer Jasotha Sanmugarajah Georgia Slapp Doreen Tapsall Jeanie White Laurelie R Wishart |
| author_facet | David Wyld Afaf Girgis Elizabeth Miller Penelope M Webb Gunter Hartel Karen Martin Rahul Ladwa Melissa Eastgate Suzanne O’Brien Sabe Sabesan Raymond J Chan Amy Brown Robert Mason Mark B Pinkham Bena Brown Louisa G Collins Fiona Crawford Williams Kerrie Doupain Vicki Fennelly Peter McGuire Rebecca Packer Jasotha Sanmugarajah Georgia Slapp Doreen Tapsall Jeanie White Laurelie R Wishart |
| author_sort | David Wyld |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ACTRN12620001290987. |
| format | Article |
| id | doaj-art-d61317741f3e401cb175583bed5b43e4 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-d61317741f3e401cb175583bed5b43e42025-08-20T02:27:53ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2024-090836Patient 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 cancerDavid Wyld0Afaf Girgis1Elizabeth Miller2Penelope M Webb3Gunter Hartel4Karen Martin5Rahul Ladwa6Melissa Eastgate7Suzanne O’Brien8Sabe Sabesan9Raymond J Chan10Amy Brown11Robert Mason12Mark B Pinkham13Bena Brown14Louisa G Collins15Fiona Crawford Williams16Kerrie Doupain17Vicki Fennelly18Peter McGuire19Rebecca Packer20Jasotha Sanmugarajah21Georgia Slapp22Doreen Tapsall23Jeanie White24Laurelie R Wishart258 Faculty of Medicine, The University of Queensland, Herston, Queensland, AustraliaIngham Institute of Applied Research, UNSW, Sydney, New South Wales, Australia4 Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia1 Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia1 Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia1 Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia4 Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia7 Cancer Care Services, Royal Brisbane and Women`s Hospital, Herston, Queensland, Australia1 Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia3 Townsville University Hospital, Townsville, Queensland, Australia4 Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia3 Townsville University Hospital, Townsville, Queensland, Australia11 Gold Coast University Hospital, Southport, Queensland, Australia4 Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia2 School of Public Health, The University of Queensland, Herston, Queensland, Australia1 Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia6 Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia4 Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia1 Population Health Program, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia7 Cancer Care Services, Royal Brisbane and Women`s Hospital, Herston, Queensland, Australia13 School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Queensland, Australia11 Gold Coast University Hospital, Southport, Queensland, Australia3 Townsville University Hospital, Townsville, Queensland, Australia4 Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia11 Gold Coast University Hospital, Southport, Queensland, Australia4 Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, Queensland, AustraliaIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ACTRN12620001290987.https://bmjopen.bmj.com/content/14/11/e090836.full |
| spellingShingle | David Wyld Afaf Girgis Elizabeth Miller Penelope M Webb Gunter Hartel Karen Martin Rahul Ladwa Melissa Eastgate Suzanne O’Brien Sabe Sabesan Raymond J Chan Amy Brown Robert Mason Mark B Pinkham Bena Brown Louisa G Collins Fiona Crawford Williams Kerrie Doupain Vicki Fennelly Peter McGuire Rebecca Packer Jasotha Sanmugarajah Georgia Slapp Doreen Tapsall Jeanie White Laurelie R Wishart 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/11/e090836.full |
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