NCT02996201

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Adverse Event
• Cancer, Breast
• Chemotherapeutic Toxicity
• Patient Outcomes Assessments

Interventions

Type	Name	Description
OTHER	Completion of PRO-CTCAE items before consultation	Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-12-19
• Last updated: 2017-10-18