Medication Reconciliation in Oncologic Patients (PROF2)

March 11, 2021 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

An Integrated Model to Increase Medication Recognition and Reconciliation in Oncologic Patients

To improve medication reconciliation in oncologic patients in healthcare transitions through an alliance between a Cancer Institute and the community pharmacies and a new integrated IT platform.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial will explore the alliance between a Cancer Institute and the community pharmacies to improve medication reconciliation in healthcare transitions, and will validate a new integrated IT platform.

Cancer patients receiving an oncologic treatment will be asked to choose a pharmacy participating to the trial, and to perform the pharmacological survey before every cycle of chemotherapy.

This will be sent through the new IT platform to the electronic medical record of IRST, and the Oncologist will perform the reconciliation.

Data about concomitant medications and possible interactions will be exensively analyzed.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult ≥18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Patients receiving an anticancer treatment
  • Clear understanding of the Italian language; written informed consent.

Exclusion Criteria:

- None

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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reconciliation
Interventional trial without drugs
Other: medication reconciliation
medication reconciliation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication recognition and reconciliation maintenance
Time Frame: At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)
number of reconciliations per patient
At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)

Collaborators and Investigators

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

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

  • Principal Investigator: martina minguzzi, Irccs Irst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 12, 2019

Primary Completion (Anticipated)

January 15, 2022

Study Completion (Anticipated)

June 15, 2022

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRST 100.40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

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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