Clinical trial · Observational
Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine
Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine (PREM-ECM)
NCT05386602CI-TRIAL-00081333PREM-ECMcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a four stage, non-interventional study to develop and pilot test a Patient Reported Experience Measure (PREM) in experimental cancer medicine trials.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Prior trial patients
- description
- In stage III, patients who have been on an experimental cancer medicine trial for less than six weeks will complete a draft PREM-ECM (less than six weeks), the EORTC PATSATC33 and HAD questionnaires at entry to the PREM study (baseline/time point 1 (T1)). Approximately 50 patients will be asked to repeat the draft of the PREM-ECM (less than six weeks) approximately one week later at time point 2 (T2). In stage IV, the PREM-ECM will be administered alone.
- label
- On trial patients
- description
- In stage III, patients who have been on an experimental cancer medicine trial for more than six weeks will complete a draft PREM-ECM (more than six weeks), the EORTC PATSATC33 and HAD questionnaires at entry to the PREM study (baseline/time point 1 (T1)). Approximately 50 patients will be asked to repeat the draft of the PREM-ECM (more than six weeks) approximately one week later at time point 2 (T2). In stage IV, the PREM-ECM will be administered alone.
- label
- Carers of patients
- description
- In stage III, carers of patients recruited on an experimental cancer medicine trial will be asked to complete a draft PREM-ECM-carers, the Adult Carer Quality of Life Questionnaire (AC-QOL), the EQ5D-5L, and the Hospital Anxiety and Depression Scale (HADS) at entry to the PREM study (baseline/time point 1 (T1)). Approximately 50 carers will be asked to repeat the draft of the PREM-ECM-carers approximately one week later at time point 2 (T2). In Stage IV, the PREM-ECM-carer will be administered alone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patient Inclusion Criteria: * Recruited into a phase 1-2 experimental cancer medicine clinical trial * Ability to understand and communicate in the English language * Able to provide written informed consent Patient Exclusion Criteria: * Patients who are not able to complete informed consent or the study questionnaires Carer Inclusion Criteria: * Ability to understand and communicate in the English language * Able to provide written informed consent * Nominated by the patient as their primary caregiver/most able to describe relevant experience Carer Exclusion Criteria: * Carers who are not able to complete informed consent or the study questionnaires
References
Publications (0)
Data not yet available
No reference posted for this study.