Clinical trial · Interventional
Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial
Electronic Patient Reporting of Side Effects to Chemotherapy Among Breast Cancer Patients Using the Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Cluster Randomized Controlled Trial
- 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)
The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.
Conditions
Conditions (4)
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 Event | — | UNRESOLVED | — |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Patient Outcomes Assessments | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Completion of PRO-CTCAE items before consultation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Electronic reporting of PRO-CTCAE items
- description
- Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
- interventionNames
- Other: Completion of PRO-CTCAE items before consultation
- type
- NO_INTERVENTION
- label
- Standard practice
Primary outcomes (1)
- measure
- Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
- timeFrame
- up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Gender •Female: only female participants are being studied Minimum age •18 years Maximum age •N/A Accepts Healthy Volunteers •No Eligibility Criteria Inclusion criteria * Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics Exclusion Criteria: * More than six scheduled cycles of chemotherapy * Not able to read and understand Danish language
References
Publications (2)
- DERIVEDPappot H, Baeksted CW, Nissen A, Knoop A, Mitchell SA, Christensen J, Hjollund NH, Johansen C. Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study. Breast Cancer. 2021 Sep;28(5):1096-1099. doi: 10.1007/s12282-021-01244-x. Epub 2021 Apr 9. PMID 33837509
- DERIVEDBaeksted CW, Nissen A, Knoop AS, Pappot H. Patients' experience of communication and handling of symptomatic adverse events in breast cancer patients receiving adjuvant chemotherapy. Res Involv Engagem. 2019 Nov 20;5:36. doi: 10.1186/s40900-019-0171-1. eCollection 2019. PMID 31832240