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Onco-haematology Vigilance Card

Impact of an Onco-haematology Vigilance Card in the Optimisation of the Town-hospital Relationship.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04931329
Acronym
THERANOVA-LIM
Enrollment
100
Registered
2021-06-18
Start date
2021-11-08
Completion date
2026-12-01
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematology, Medical Oncology, Molecular Targeted Therapies

Brief 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.

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.

Interventions

None listed

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* All patients treated at Limoges University Hospital in Medical Oncology department, receiving oral treatment (chemotherapy and/or targeted therapies)

Exclusion criteria

* All patients treated at Limoges University Hospital in Medical Oncology department, receiving hormone therapy or IV treatment only.

Design outcomes

Primary

MeasureTime frameDescription
measure patient satisfaction at 3 months3 monthsPatient satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)

Secondary

MeasureTime frameDescription
Measurement of caregiver satisfaction3 monthsCaregiver satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)
Measurement of compliance reported by the GIRERD questionnaire3 monthspatients 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
Measuring the satisfaction of treating physicians and health professionals3 monthsTreating 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)
Evaluate the use of the QR code by health professionals/carers3 monthsThe use of the QR code with be evaluated by counting how many times it will be flashed during study period.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026