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

Not Applicable

Completed

• Conditions: Adverse Event; Patient Outcomes Assessments; Chemotherapeutic Toxicity; Cancer, Breast
• Interventions: Other: Completion of PRO-CTCAE items before consultation

• Registration Number: NCT02996201
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-19
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic reporting of PRO-CTCAE items	Completion of PRO-CTCAE items before consultation	Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Primary Outcome Measures

Name	Time	Method
Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)	up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017

Secondary Outcome Measures

Name	Time	Method
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
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
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
Patient and staff compliance as registerede by the software used	up to 18 weeks (November 1, 2015 - 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