Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients (ONCORAL-Covid)

January 7, 2022 updated by: Hospices Civils de Lyon

Assessment of the Impact of the COVID-19 Pandemic on Drug Use and on the Perception of Remote Monitoring by Cancer Patients Followed in the ONCORAL Program

The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus.

Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital.

This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

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

  • France
      • Pierre-Bénite, France, 69495
        • Service Pharmaceutique, Hospices Civils de Lyon

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

Sampling Method

Non-Probability Sample

Study Population

Patients treated with oral cancer drugs included in the Oncoral multidisciplinary outpatient / hospital program of the Hospices Civils de Lyon and having benefited from remote monitoring during the COVID-19 pandemic-related containment period between March 16, 2020 and May 11, 2020.

Description

Inclusion Criteria:

  • Adult patients aged 18 and over
  • Ambulatory patients treated with oral anticancer drugs and benefiting from the ONCORAL multidisciplinary outpatient / hospital program
  • Having benefited from a remote monitoring between March 16, 2020 and May 11, 2020 (the COVID-19 pandemic-related containment period)
  • Patients who do not object to participating in the survey and to the use of the data collected

Exclusion Criteria:

  • Patients who do not speak French
  • Patients living in an institution
  • Patients protected by law
  • Patients included in a drug clinical trial
  • Patients refusing to participate in the survey and / or not responding to the 2 telephone calls requesting their participation and / or not responding to any of these calls
  • Patients choosing to stop the interview and no longer answering to the questions asked

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with oral anticancer drugs
Patients treated with oral anticancer drugs followed in the Oncoral program
Other: Directive Interview
One directive interview conducted by telephone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients reporting a change in drug use during the COVID-19 pandemic-related containment period.
Time Frame: Inclusion
Percentage of patients reporting a change in medication use and / or a change medication management and / or a change in oral anticancer drug adherence during the COVID-19 pandemic-related containment period.
Inclusion

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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)

October 5, 2021

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

January 5, 2022

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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