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RECRUITING
NCT05345587
NA

Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

Summary

Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2022-09-16

Completion Date

2026-10

Last Updated

2024-04-26

Healthy Volunteers

No

Conditions

Interventions

OTHER

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

Locations (6)

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