Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05345587

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-04-26

196

Participants Needed

6

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer
  • Patient able to use a connected electronic device
  • Patient has a smartphone, tablet, or computer with internet access and an email address
  • Patient with WHO performance status of 2 or less
  • Patients receiving other cancer therapy concurrently with oral therapy may be included
  • Patient has provided free and informed consent and signed the consent form
  • Patient is a member or beneficiary of a health insurance plan
Not Eligible

You will not qualify if you...

  • Participating in a category 1 interventional study or within an exclusion period from a previous study
  • Refuses to sign the consent form
  • Unable to receive informed information
  • Under legal protection such as safeguard of justice or state guardianship
  • Pregnant, parturient, or breastfeeding
  • Illiterate patient
  • Has poor prognosis due to serious uncontrolled medical conditions or mild systemic disease
  • Has uncontrolled infections including cardiac, pulmonary, or renal conditions
  • Receiving hormone therapy alone for breast or prostate cancer

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Centre Hospitalier Dubois Brive

Brive-la-Gaillarde, France, 19100

Actively Recruiting

2

Chic Castres-Mazamet

Castres, France, 81108

Actively Recruiting

3

Centre Hospitalier Emile ROUX

Le Puy-en-Velay, France, 43 012

Actively Recruiting

4

CHU de Nîmes

Nîmes, France

Actively Recruiting

5

Institut cancerologie du Gard

Nîmes, France

Actively Recruiting

6

Médipôle Lyon-Villeurbanne

Villeurbanne, France, 69100

Actively Recruiting

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Research Team

F

Frédéric Fiteni

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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