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

Rigshospitalet, Denmark0 sites700 target enrollmentNovember 2015

ConditionsAdverse Event Cancer, Breast Chemotherapeutic Toxicity Patient Outcomes Assessments

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adverse Event
Sponsor: Rigshospitalet, Denmark
Enrollment: 700
Primary Endpoint: Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

January 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Rigshospitalet, Denmark

Responsible Party

Principal Investigator

Helle Pappot

Chief physician

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•More than six scheduled cycles of chemotherapy
•Not able to read and understand Danish language

Outcomes

Primary Outcomes

Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)

Time Frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017

Secondary Outcomes

Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews(up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017)
Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)
Patient and staff compliance as registerede by the software used(up to 18 weeks (November 1, 2015 - January 31, 2017))
Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)
Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)
Handling of side effects documented in the medical record(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)