Medical OncologyTHERANOVA-LIMNCT04931329
Onco-haematology Vigilance Card
An observational study of Medical Oncology and Hematology, run by University Hospital, Limoges at 1 site in France.
Trial summary
The objective of this study is to show the interest of setting up a drug vigilance card in Oncology in order to reinforce patient safety, develop compliance and avoid drug interactions when the patient consults town professionals or other specialists. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Oncology, Hematology, Molecular Targeted Therapies
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with onco-heamatologic disease treated with oral treatment (chemotherapy and/or targeted thérapies)
Who may be able to join
- All patients treated at Limoges University Hospital in Medical Oncology department, receiving oral treatment (chemotherapy and/or targeted therapies)
Who cannot join
- All patients treated at Limoges University Hospital in Medical Oncology department, receiving hormone therapy or IV treatment only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Onco-haematology Vigilance Card in the Optimisation of the Town-hospital Relationship.
The objective of this study is to show the interest of setting up a drug vigilance card in Oncology in order to reinforce patient safety, develop compliance and avoid drug interactions when the patient consults town professionals or other specialists.
Read the detailed description
Recent developments in oral chemotherapy and targeted therapies have radically changed cancer patient management; ambulatory care is now common. Oral therapies afford many advantages, improving patient quality of life and autonomy by reducing hospital stays and involving patients in their own care. Optimising the care of cancer patients at home requires the coordinated intervention of hospital and town healthcare professionals and involvement of the patient to detect, prevent, and manage adverse events, avoid drug interactions, and educate patients. Preliminary work in haematology has highlighted (n = 31 patients) the interest of a "drug vigilance card" in three indications (Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukaemia and Multiple Myeloma) with an increase in the town-hospital link.
This is an prospective cohort study. Following the announcement consultation, in addition to the personalised care plan, the information about the treatment will be contained in a drug monitoring card that will be given to the patient by the health professional (doctor or nurse). This drug monitoring card should be presented to the health professionals by the patient. During the entire period of treatment, the patient will have a card.
- Conditions
- Medical Oncology, Hematology, Molecular Targeted Therapies
What is being measured
The primary outcome is the main question the study is designed to answer.
measure patient satisfaction at 3 months
Patient satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)
Measured: 3 months
Secondary outcomes (4)
Measurement of caregiver satisfaction
Caregiver satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)
Measured: 3 months
Measurement of compliance reported by the GIRERD questionnaire
patients will have to answer shorts questions on GIRERD* questionnaire to evaluate their Medication compliance to oral anticancer drugs.
*X. Girerd, O. Hanon, K. Anagnostopoulos, C. Ciupek, J.J. Mourad, S. Consoli Assessment of antihypertensive compliance using a self-administered questionnaire: development and use in a hypertension clinic Presse Med, 30 (2001), pp. 1044-1048
Measured: 3 months
Measuring the satisfaction of treating physicians and health professionals
Treating physicians ad health professionnals satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)
Measured: 3 months
Evaluate the use of the QR code by health professionals/carers
The use of the QR code with be evaluated by counting how many times it will be flashed during study period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Nov 2021
- Primary completion10 Jun 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical OncologyStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931329
- Sponsor's protocol ID
- 87RI21_0010
- Acronym
- THERANOVA-LIM
- Status last verified
- Jun 2026
- First submitted
- 10 May 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boucheteil M, Leobon S, Baffert KA, Huet S, Darbas T, Le Brun-Ly V, Pestre J, Peyramaure C, Thuillier F, Venat L, Jost J, Touati M, Deluche E. [THERANOVA-LIM: Improving access to information on oral treatments for patients and pharmacists]. Bull Cancer. 2026 Mar;113(3):315-327. doi: 10.1016/j.bulcan.2025.10.005. Epub 2025 Dec 17. French.
PubMed 41412846
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Onco-haematology Vigilance Card in the Optimisation of the Town-hospital Relationship.
- ClinicalTrials.gov ID
- NCT04931329
- Acronym / sponsor ID
- THERANOVA-LIM / 87RI21_0010
- Conditions
- Medical Oncology, Hematology, Molecular Targeted Therapies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jun 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 objective of this study is to show the interest of setting up a drug vigilance card in Oncology in order to reinforce patient safety, develop compliance and avoid drug interactions when the patient consults town professionals or other specialists.
Detailed description
Recent developments in oral chemotherapy and targeted therapies have radically changed cancer patient management; ambulatory care is now common. Oral therapies afford many advantages, improving patient quality of life and autonomy by reducing hospital stays and involving patients in their own care. Optimising the care of cancer patients at home requires the coordinated intervention of hospital and town healthcare professionals and involvement of the patient to detect, prevent, and manage adverse events, avoid drug interactions, and educate patients. Preliminary work in haematology has highlighted (n = 31 patients) the interest of a "drug vigilance card" in three indications (Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukaemia and Multiple Myeloma) with an increase in the town-hospital link.
This is an prospective cohort study. Following the announcement consultation, in addition to the personalised care plan, the information about the treatment will be contained in a drug monitoring card that will be given to the patient by the health professional (doctor or nurse). This drug monitoring card should be presented to the health professionals by the patient. During the entire period of treatment, the patient will have a card.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with onco-heamatologic disease treated with oral treatment (chemotherapy and/or targeted thérapies)
Key inclusion criteria (1 listed)
- All patients treated at Limoges University Hospital in Medical Oncology department, receiving oral treatment (chemotherapy and/or targeted therapies)
Key exclusion criteria (1 listed)
- All patients treated at Limoges University Hospital in Medical Oncology department, receiving hormone therapy or IV treatment only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measure patient satisfaction at 3 months
Time frame: 3 months
Patient satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)
4 secondary outcomes
Measurement of caregiver satisfaction
Time frame: 3 months
Measurement of compliance reported by the GIRERD questionnaire
Time frame: 3 months
Measuring the satisfaction of treating physicians and health professionals
Time frame: 3 months
Evaluate the use of the QR code by health professionals/carers
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 41412846Boucheteil M, Leobon S, Baffert KA, Huet S, Darbas T, Le Brun-Ly V, Pestre J, Peyramaure C, Thuillier F, Venat L, Jost J, Touati M, Deluche E. [THERANOVA-LIM: Improving access to information on oral treatments for patients and pharmacists]. Bull Cancer. 2026 Mar;113(3):315-327. doi: 10.1016/j.bulcan.2025.10.005. Epub 2025 Dec 17. French.
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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 Medical Oncology and Hematology, run by University Hospital, Limoges 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
measure patient satisfaction at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04931329, which also lists 1 linked publication.
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 26 Jun 2026.