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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02996201
Other study ID # R113-A7084-14-S34
Secondary ID
Status Completed
Phase N/A
First received November 4, 2016
Last updated October 17, 2017
Start date November 2015
Est. completion date January 2017

Study information

Verified date October 2017
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Completion of PRO-CTCAE items before consultation
Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Danish Cancer Society

Outcome

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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