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

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 Overview

• Status: Completed
• Conditions: Chemotherapeutic Toxicity; Cancer, Breast; Adverse Event; Patient Outcomes Assessments
• Intervention / Treatment: Other: Completion of PRO-CTCAE items before consultation

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic reporting of PRO-CTCAE items; Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy	Other: Completion of PRO-CTCAE items before consultation; Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
No Intervention: Standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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
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
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
Patient and staff compliance as registerede by the software used	up to 18 weeks (November 1, 2015 - January 31, 2017)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Danish Cancer Society

Publications and helpful links

General Publications

• Pappot 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.
• Baeksted 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: R113-A7084-14-S34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No