CancerONCORAL-CovidNCT05069662
Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients
An observational study of Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Directive Interview
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2021to 5 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service Pharmaceutique, Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Directive Interview
- Keywords
- remote monitoring, oral anticancer drugs, drug intake, COVID-19 pandemic
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directive InterviewOther
One directive interview conducted by telephone
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with oral anticancer drugs | Patients treated with oral anticancer drugs followed in the Oncoral program Receives: Other: Directive Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start5 Oct 2021
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069662
- Sponsor's protocol ID
- 69HCL21_0163
- Acronym
- ONCORAL-Covid
- Status last verified
- Jan 2022
- First submitted
- 4 Oct 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05069662
- Acronym / sponsor ID
- ONCORAL-Covid / 69HCL21_0163
- Conditions
- Cancer
- Keywords
- remote monitoring, oral anticancer drugs, drug intake, COVID-19 pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with oral anticancer drugs | – | Other: Directive InterviewPatients treated with oral anticancer drugs followed in the Oncoral program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Directive InterviewOne directive interview conducted by telephone | Other | Patients treated with oral anticancer drugs |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients reporting a change in drug use during the COVID-19 pandemic-related containment period. (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.