Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

Rigshospitalet, Denmark700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

700

Conditions

Adverse Event Cancer, Breast Chemotherapeutic Toxicity Patient Outcomes Assessments

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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