Responsible Side Effects Management in Oncology (R-SEMO)

November 4, 2020 updated by: Robert Šeparović, University Hospital "Sestre Milosrdnice"

Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report

Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's reported by patient with the ones recognised by the oncologist, and vice versa, during antineoplastic treatment.

Study Type

Observational

Enrollment (Actual)

267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Croatia, Europe
      • Zagreb, Croatia, Europe, Croatia, 10 000
        • UHC Sestre milorsdnice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all cancer patients actively receiving systemic antineoplastic treatment, ECOG 0-2

Description

Inclusion Criteria:

all cancer patients receiving systemic antineoplastic treatment, ECOG 0-2

Exclusion Criteria:

age <18, >75; other active and severe comorbidities; no solid cancer; IUC patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of perspectives
Time Frame: may 2016 until october 2016
comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment
may 2016 until october 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital "Sestre Milosrdnice"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

September 5, 2017

Study Completion (Actual)

September 5, 2017

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2312201522122016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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