Onco-haematology Vigilance Card

NCT ID: NCT04931329

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-02

Study Completion Date

2022-06-30

Brief Summary

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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

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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

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Medical Oncology Hematology Molecular Targeted Therapies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Limoges

Limoges, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elise Deluche, M.D

Role: CONTACT

Phone: +33555056309

Email: [email protected]

Facility Contacts

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Deluche Elise, MD

Role: primary

Lavau-Denes Sandrine, MD

Role: backup

Other Identifiers

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87RI21_0010

Identifier Type: -

Identifier Source: org_study_id