Adverse Event, Cancer, Breast, Chemotherapeutic Toxicity, Patient Outcomes Assessments
Conditions
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.
Interventions
OTHERCompletion of PRO-CTCAE items before consultation
Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
Sponsors
Danish Cancer Society
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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) |
| 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 |
Outcome results
None listed