NCT05069662

Brief Summary

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oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

October 4, 2021

Last Update Submit

January 7, 2022

Conditions

Keywords

remote monitoringoral anticancer drugsdrug intakeCOVID-19 pandemic

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients reporting a change in drug use during the COVID-19 pandemic-related containment period.

    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

Study Arms (1)

Patients treated with oral anticancer drugs

Patients treated with oral anticancer drugs followed in the Oncoral program

Other: Directive Interview

Interventions

One directive interview conducted by telephone

Patients treated with oral anticancer drugs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Pharmaceutique, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 6, 2021

Study Start

October 5, 2021

Primary Completion

January 5, 2022

Study Completion

January 5, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations