Clinical trial · Interventional
PREMs on PROMs in Breast Disease (PREMs_PROMs)
Electronic Patient Reported Outcome Measures (ePROMs) in Patients With Breast Disease: An Open-label, Randomized Controlled Trial on Patient Reported Experience Measures (PREMs) and Effectivity (PREMs_PROMs)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In recent years, large interest in the conduct and focus of clinical trials has focused to patient related outcomes and value-based healthcare. Patient Reported Outcome MeasureS, (PROMs) has become one of the standard instruments used for measuring outcomes; multiple PROMS have been extensively validated and are used in many clinical studies, but also in clinical routine. Additionally, Patient Reported Experience MeasureS (PREMS) allow for real-time feedback on the integration of care and can subsequently drive changes in health provision systems. In the present trial, the mode of delivery of PROMS is examined in terms of effectivity and patient experience (PREMS) in the setting of breast disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Disease | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| e-PROMS | Other | — | UNRESOLVED |
| p-PROMS | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- e-PROMS
- description
- Patients allocated to the e-PROMS arm will fill an online version of PROMS and then respond to the e-PREMS questionnaire.
- interventionNames
- Other: e-PROMS
- type
- ACTIVE_COMPARATOR
- label
- p-PROMS
- description
- Patients allocated to the p-PROMS arm will fill in PROMS in paper form (p-PROMS) and then respond to the p-PREMS questionnaire.
- interventionNames
- Other: p-PROMS
Primary outcomes (2)
- measure
- Response rate
- timeFrame
- Up to 8 weeks after receiving the questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients seeking or being treated for perceived or verified, benign or malignant breast disease. * Women undergoing screening mammography. Exclusion Criteria: * Linguistic barriers. * Deprivation of liberty.
References
Publications (1)
- DERIVEDPantiora E, Hedman LC, Aristokleous I, Sjokvist O, Karakatsanis A, Schiza A. Effect of mode of delivery of patient reported outcomes in patients with breast disease: a randomised controlled trial. Int J Surg. 2024 Jan 1;110(1):176-182. doi: 10.1097/JS9.0000000000000815. PMID 37800546