- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02996201
Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial
October 17, 2017 updated by: Helle Pappot, Rigshospitalet, Denmark
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
700
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
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)
Time Frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
|
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
Time Frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
|
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
Time Frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
|
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
Time Frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
|
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
Time Frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
|
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
Time Frame: up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017
|
up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017
|
Patient and staff compliance as registerede by the software used
Time Frame: up to 18 weeks (November 1, 2015 - January 31, 2017)
|
up to 18 weeks (November 1, 2015 - January 31, 2017)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- R113-A7084-14-S34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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