Clinical trial · Interventional
The Use of PatientReportedOutcomes (PRO)- CTCAE by Melanoma Patients Receiving Immunotherapy
The Use of PRO-CTCAE by Patients Receiving Immunotherapy for the Treatment of Malignant Melanoma
NCT03073031CI-TRIAL-00063428completedN/AClinicalTrials.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 study evaluates if melanoma patients who report their side effects to immunotherapy weekly by the use of ePRO-CTCAE will experience an overall reduction of grade 3 and 4 events with 50% compared to routine monitoring carried out every 3 weeks.
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 |
|---|---|---|---|
| Adverse Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tablet: Samsung Galaxy Tab A | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- description
- Patients report their adverse events on a tablet once a week (intervention) as a supplement to having them monitored every 3 weeks by a physician
- interventionNames
- Device: Tablet: Samsung Galaxy Tab A
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients have their side effects monitored by a physician every 3 weeks (control)
Primary outcomes (1)
- measure
- The number of patients who experience drug-related grade 3 or 4 adverse events assessed by CTCAE 4.0 will be reduced by 50% in the intervention arm compared to patients in the control arm
- timeFrame
- The first 6 months of treatment with immunotherapy
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥18 years of age * who read and understand Danish, * who have been diagnosed with malignant melanoma, * who are about to be treated with immunotherapy for their disease (1st and 2nd line, mono-therapy and combination therapy). * Moreover, patients must have signed and dated a written informed consent form in accordance with regulatory and institutional guidelines and 6) be willing and able to comply with the completion of PRO-CTCAE and other required questionnaires. Exclusion Criteria: \- None
References
Publications (3)
- DERIVEDTolstrup LK, Pappot H, Bastholt L, Moller S, Dieperink KB. Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial. J Patient Rep Outcomes. 2022 Jan 21;6(1):8. doi: 10.1186/s41687-022-00414-5. PMID 35061112
- DERIVEDTolstrup LK, Bastholt L, Dieperink KB, Moller S, Zwisler AD, Pappot H. The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial. J Patient Rep Outcomes. 2020 Oct 30;4(1):88. doi: 10.1186/s41687-020-00255-0. PMID 33125537
- DERIVEDTolstrup LK, Pappot H, Bastholt L, Zwisler AD, Dieperink KB. Patient-Reported Outcomes During Immunotherapy for Metastatic Melanoma: Mixed Methods Study of Patients' and Clinicians' Experiences. J Med Internet Res. 2020 Apr 9;22(4):e14896. doi: 10.2196/14896. PMID 32271150