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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996201
• Other study ID #: R113-A7084-14-S34
• 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
• 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

Related Conditions & MeSH terms

• Adverse Event
• Breast Neoplasms
• Cancer, Breast
• Chemotherapeutic Toxicity
• Patient Outcomes Assessments

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)