Chemotherapeutic Toxicity Clinical Trial
Official title:
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
Verified date | October 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 700 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Danish Cancer Society |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Patient and staff compliance as registerede by the software used | up to 18 weeks (November 1, 2015 - January 31, 2017) |
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