Onco-haematology Vigilance Card (THERANOVA-LIM)

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.

Study Overview

• Status: Recruiting
• Conditions: Medical Oncology; Hematology; Molecular Targeted Therapies

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Elise Deluche, M.D; Phone Number: +33555056309; Email: elise.deluche@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87042
    • Recruiting
    • CHU de Limoges
    • Contact: Deluche Elise, MD; Phone Number: +33505556309; Email: elise.deluche@chu-limoges.fr
    • Contact: Lavau-Denes Sandrine, MD; Phone Number: +33505556397; Email: sandrine.lavau-denes@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with onco-heamatologic disease treated with oral treatment (chemotherapy and/or targeted thérapies)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 87RI21_0010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No