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NCT Number: NCT04931329

Onco-haematology Vigilance Card

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Medical Oncology Hematology Molecular Targeted Therapies

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Limoges

Limoges, 87042, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Measurement of caregiver satisfaction

    Time frame: 3 months

    Caregiver satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)

  2. Measurement of compliance reported by the GIRERD questionnaire

    Time frame: 3 months

    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

  3. Measuring the satisfaction of treating physicians and health professionals

    Time frame: 3 months

    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)

  4. Evaluate the use of the QR code by health professionals/carers

    Time frame: 3 months

    The use of the QR code with be evaluated by counting how many times it will be flashed during study period.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: THERANOVA-LIM

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jun 18, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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