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

NCT02996201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2017-10-18

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Completion of PRO-CTCAE items before consultation

Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-01-31
Completion
2017-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02996201 on ClinicalTrials.gov