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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adverse Event, Cancer, Breast, Chemotherapeutic Toxicity, Patient Outcomes Assessments

Intervention / Treatment
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* Other: Completion of PRO-CTCAE items before consultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |