Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin
Abstract Background People with malignancy of undefined primary origin (MUO) have a poor prognosis and may undergo a protracted diagnostic workup causing patient distress and high cancer related costs. Not having a primary diagnosis limits timely site-specific treatment and access to precision medic...
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2025-01-01
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| Online Access: | https://doi.org/10.1186/s12885-025-13506-4 |
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| author | Anna Ugalde Richard W. Tothill Stephen Quinn Hui-Li Wong Owen Prall Catherine Mitchell Nilmini Wickramasinghe Clare Fedele Natalie Richards Elizabeth Todio Cindy Bryant Louisa G. Collins Sarah McLean Hyun Soo Ko Tim Akhurst Christopher Steer Bo Gao Mark Wong Chloe Georgiou Narayan Karanth Anna Kuchel Louise Nott Shamsudheen Padinharakam Mark Shackleton Ian M. Collins Madhu Singh Rachel Wong Zee Wan Wong Alexis Butler Tharani Sivakumaran Penelope Schofield Linda Mileshkin |
| author_facet | Anna Ugalde Richard W. Tothill Stephen Quinn Hui-Li Wong Owen Prall Catherine Mitchell Nilmini Wickramasinghe Clare Fedele Natalie Richards Elizabeth Todio Cindy Bryant Louisa G. Collins Sarah McLean Hyun Soo Ko Tim Akhurst Christopher Steer Bo Gao Mark Wong Chloe Georgiou Narayan Karanth Anna Kuchel Louise Nott Shamsudheen Padinharakam Mark Shackleton Ian M. Collins Madhu Singh Rachel Wong Zee Wan Wong Alexis Butler Tharani Sivakumaran Penelope Schofield Linda Mileshkin |
| author_sort | Anna Ugalde |
| collection | DOAJ |
| description | Abstract Background People with malignancy of undefined primary origin (MUO) have a poor prognosis and may undergo a protracted diagnostic workup causing patient distress and high cancer related costs. Not having a primary diagnosis limits timely site-specific treatment and access to precision medicine. There is a need to improve the diagnostic process, and healthcare delivery and support for these patients. This trial aims to implement and evaluate an optimal model of care for people presenting with MUO to reduce time to diagnosis, improve patient experiences and reduce healthcare costs. Methods/design This is a pragmatic stepped-wedge cluster randomised trial comparing a control phase of standard practice with an intervention phase. Patient inclusion criteria are: 1) age 18 years or older, 2) presenting with suspected metastatic malignancy without an obvious primary site on imaging, 3) clinically appropriate to undergo diagnostic work-up and 4) able to provide written or verbal consent. The intervention is a new model of care comprising four key components: standardised diagnostic workup, dedicated cancer care coordinators, virtual multidisciplinary meetings and a website resource for patients, carers and clinicians. The primary endpoint is the time to completion of minimum diagnostic workup. Secondary outcomes are whether the type of tumour is diagnosed, clinical trial participation, referral to palliative care, patient-reported physical, social and mental health, patient-reported understanding and uncertainty. Implementation outcomes include acceptability, feasibility, fidelity and adoption and health care use and costs. Intervention implementation will be supported using clinical leadership, education and reinforcement. Patients who consent to having their data collected will receive the model of care active at the site at the time of recruitment. Patients will complete a patient-reported outcomes questionnaire four months after study enrolment. A health economic analysis will be included. Across 15 hospitals, a total sample size of 240 is planned. Discussion There is a lack of intervention research for people presenting with MUO. The stepped-wedge design seeks to mitigate the potential challenge of enrolling people with a poor prognosis and high symptom burden in trials. This research will generate important evidence with scalability for future research at trial completion. Trial registration ACTRN12622001504707 |
| format | Article |
| id | doaj-art-e5516ca843034865ad0e2d60552cdafc |
| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
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| series | BMC Cancer |
| spelling | doaj-art-e5516ca843034865ad0e2d60552cdafc2025-02-02T12:28:56ZengBMCBMC Cancer1471-24072025-01-0125111110.1186/s12885-025-13506-4Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary originAnna Ugalde0Richard W. Tothill1Stephen Quinn2Hui-Li Wong3Owen Prall4Catherine Mitchell5Nilmini Wickramasinghe6Clare Fedele7Natalie Richards8Elizabeth Todio9Cindy Bryant10Louisa G. Collins11Sarah McLean12Hyun Soo Ko13Tim Akhurst14Christopher Steer15Bo Gao16Mark Wong17Chloe Georgiou18Narayan Karanth19Anna Kuchel20Louise Nott21Shamsudheen Padinharakam22Mark Shackleton23Ian M. Collins24Madhu Singh25Rachel Wong26Zee Wan Wong27Alexis Butler28Tharani Sivakumaran29Penelope Schofield30Linda Mileshkin31Institute for Health Transformation, Faculty of Health, Deakin UniversityPeter MacCallum Cancer CentreSwinburne University of TechnologyPeter MacCallum Cancer CentrePeter MacCallum Cancer CentrePeter MacCallum Cancer CentreSwinburne University of TechnologyCSL InnovationPeter MacCallum Cancer CentrePeter MacCallum Cancer CentreSwinburne University of TechnologyQIMR Berghofer Medical Research InstitutePeter MacCallum Cancer CentreSir Peter MacCallum Department of Oncology, University of MelbournePeter MacCallum Cancer CentreBorder Medical Oncology, Albury Wodonga Regional Cancer CentreUniversity of SydneyDepartment of Medical Oncology, Westmead HospitalDepartment of Medical Oncology, Bendigo HealthDepartment of Medical Oncology, Royal Darwin HospitalUniversity of QueenslandDepartment of Medical Oncology, Royal Hobart HospitalLaunceston General HospitalDepartment of Oncology, Alfred HospitalInstitute for Health Transformation, Faculty of Health, Deakin UniversityBarwon HealthEastern HealthMonash HealthPeter MacCallum Cancer CentrePeter MacCallum Cancer CentreSir Peter MacCallum Department of Oncology, University of MelbournePeter MacCallum Cancer CentreAbstract Background People with malignancy of undefined primary origin (MUO) have a poor prognosis and may undergo a protracted diagnostic workup causing patient distress and high cancer related costs. Not having a primary diagnosis limits timely site-specific treatment and access to precision medicine. There is a need to improve the diagnostic process, and healthcare delivery and support for these patients. This trial aims to implement and evaluate an optimal model of care for people presenting with MUO to reduce time to diagnosis, improve patient experiences and reduce healthcare costs. Methods/design This is a pragmatic stepped-wedge cluster randomised trial comparing a control phase of standard practice with an intervention phase. Patient inclusion criteria are: 1) age 18 years or older, 2) presenting with suspected metastatic malignancy without an obvious primary site on imaging, 3) clinically appropriate to undergo diagnostic work-up and 4) able to provide written or verbal consent. The intervention is a new model of care comprising four key components: standardised diagnostic workup, dedicated cancer care coordinators, virtual multidisciplinary meetings and a website resource for patients, carers and clinicians. The primary endpoint is the time to completion of minimum diagnostic workup. Secondary outcomes are whether the type of tumour is diagnosed, clinical trial participation, referral to palliative care, patient-reported physical, social and mental health, patient-reported understanding and uncertainty. Implementation outcomes include acceptability, feasibility, fidelity and adoption and health care use and costs. Intervention implementation will be supported using clinical leadership, education and reinforcement. Patients who consent to having their data collected will receive the model of care active at the site at the time of recruitment. Patients will complete a patient-reported outcomes questionnaire four months after study enrolment. A health economic analysis will be included. Across 15 hospitals, a total sample size of 240 is planned. Discussion There is a lack of intervention research for people presenting with MUO. The stepped-wedge design seeks to mitigate the potential challenge of enrolling people with a poor prognosis and high symptom burden in trials. This research will generate important evidence with scalability for future research at trial completion. Trial registration ACTRN12622001504707https://doi.org/10.1186/s12885-025-13506-4CancerSupportDiagnosisCareUnknown primary cancerStepped-wedge cluster |
| spellingShingle | Anna Ugalde Richard W. Tothill Stephen Quinn Hui-Li Wong Owen Prall Catherine Mitchell Nilmini Wickramasinghe Clare Fedele Natalie Richards Elizabeth Todio Cindy Bryant Louisa G. Collins Sarah McLean Hyun Soo Ko Tim Akhurst Christopher Steer Bo Gao Mark Wong Chloe Georgiou Narayan Karanth Anna Kuchel Louise Nott Shamsudheen Padinharakam Mark Shackleton Ian M. Collins Madhu Singh Rachel Wong Zee Wan Wong Alexis Butler Tharani Sivakumaran Penelope Schofield Linda Mileshkin Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin BMC Cancer Cancer Support Diagnosis Care Unknown primary cancer Stepped-wedge cluster |
| title | Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin |
| title_full | Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin |
| title_fullStr | Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin |
| title_full_unstemmed | Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin |
| title_short | Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin |
| title_sort | solving unknown primary cancer with earlier diagnosis the super ed trial study protocol for a stepped wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin |
| topic | Cancer Support Diagnosis Care Unknown primary cancer Stepped-wedge cluster |
| url | https://doi.org/10.1186/s12885-025-13506-4 |
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