Onco-haematology Vigilance Card

Medical Oncology Clinical Trial

— THERANOVA-LIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931329
• Other study ID #: 87RI21_0010
• Status: Recruiting
• Start date: November 2, 2021
• Est. completion date: June 2022

Study information

• Verified date: July 2021
• Source: University Hospital, Limoges
• Contact: Elise Deluche, M.D
• Phone: +33555056309
• Email: elise.deluche[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematology
• Medical Oncology
• Neoplasms

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months
Secondary	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)	3 months
Secondary	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	3 months
Secondary	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)	3 months
Secondary	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.	3 months