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

Last updated: April 25, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

THESS monitoring

Clinical Study ID

NCT05345587
PHRC-I/2019/FF-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient starting oral therapy treatment in oncology for metastatic or locally advancedcancer
  • Patient able to use a connected electronic object
  • Patient with a smartphone/tablet or computer with internet access and an emailaddress.
  • 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 consentform
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion

Exclusion Criteria:

  • The subject is participating in a category 1 interventional study, or is in a periodof exclusion determined by a previous study
  • 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, mildsystemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
  • Patient receiving hormone therapy alone for breast or prostate cancer

Study Design

Total Participants: 196
Treatment Group(s): 1
Primary Treatment: THESS monitoring
Phase:
Study Start date:
September 16, 2022
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Centre Hospitalier Dubois Brive

    Brive-la-Gaillarde, 19100
    France

    Active - Recruiting

  • Chic Castres-Mazamet

    Castres, 81108
    France

    Active - Recruiting

  • Centre Hospitalier Emile ROUX

    Le Puy en Velay, 43 012
    France

    Active - Recruiting

  • ICM

    Montpellier,
    France

    Site Not Available

  • CHU de Nîmes

    Nîmes,
    France

    Active - Recruiting

  • Institut cancerologie du Gard

    Nîmes,
    France

    Active - Recruiting

  • Médipôle Lyon-Villeurbanne

    Villeurbanne, 69100
    France

    Active - Recruiting

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