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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic reporting of PRO-CTCAE items | Experimental | Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy |
|
| Standard practice | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Completion of PRO-CTCAE items before consultation | Other | Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy |
|
| 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 |
| 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 |
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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
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33837509 | Derived | 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. | |
| 31832240 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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) |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |