Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy
NCT ID: NCT05345587
Last Updated: 2024-04-26
Study Results
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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RECRUITING
NA
196 participants
INTERVENTIONAL
2022-09-16
2026-10-31
Brief Summary
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Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.
Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.
Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Prolife group
scheduled consultation with the hospital clinical pharmacist, therapeutic follow-up and collection of clinical information by the patient via the THESS monitoring system
THESS monitoring
Consultation with the pharmacist to look for possible medication interactions between the oral therapy and the patient's usual treatments and to inform the patient about his treatment to improve QOL and compliance. Consultation and follow-up by a nurse. Weekly notification by THESS Application of the symptoms experienced by the patient over the last 7 days
Standard care
No interventions assigned to this group
Interventions
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THESS monitoring
Consultation with the pharmacist to look for possible medication interactions between the oral therapy and the patient's usual treatments and to inform the patient about his treatment to improve QOL and compliance. Consultation and follow-up by a nurse. Weekly notification by THESS Application of the symptoms experienced by the patient over the last 7 days
Eligibility Criteria
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Inclusion Criteria
* Patient able to use a connected electronic object
* Patient with a smartphone/tablet or computer with internet access and an email address.
* Patient with WHO status ≤2
* Patients receiving other cancer therapy concurrently with oral therapy may be included
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
Exclusion Criteria
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient pregnant, parturient or breast feeding
* Illiterate patient
* Patients with poor prognosis due to a serious uncontrolled medical condition, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
* Patient receiving hormone therapy alone for breast or prostate cancer
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Frédéric Fiteni
Role: PRINCIPAL_INVESTIGATOR
CHU de Nimes
Locations
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Centre Hospitalier Dubois Brive
Brive-la-Gaillarde, , France
Chic Castres-Mazamet
Castres, , France
Centre Hospitalier Emile ROUX
Le Puy-en-Velay, , France
CHU de Nîmes
Nîmes, , France
Institut cancerologie du Gard
Nîmes, , France
Médipôle Lyon-Villeurbanne
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Nicolas MADRANGES
Role: primary
BOTIN
Role: primary
Brigitte MONANGE
Role: primary
Marie BEGUINOT
Role: primary
Other Identifiers
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PHRC-I/2019/FF-01
Identifier Type: -
Identifier Source: org_study_id
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