Clinical trial NCT02996201: Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Event
Cancer, Breast
Chemotherapeutic Toxicity
Patient Outcomes Assessments
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2016-12-19
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
timeFrame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
Secondary outcomes:
measure: Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy
timeFrame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy
timeFrame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy
timeFrame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Handling of side effects documented in the medical record
timeFrame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews
timeFrame: up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017
measure: Patient and staff compliance as registerede by the software used
timeFrame: up to 18 weeks (November 1, 2015 - January 31, 2017)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.