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

NCT05345587 | Recruiting

• 1 other identifier: PHRC-I/2019/FF-01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Time until decrease in quality of life by 5-points between groups

  Quality of life calculated every 3 months using EORTC QLQ-C30 for which a decrease of 5-points is considered to be the minimal clinically important difference

  End of follow-up maximum 18 months

Secondary Outcomes (35)

• Time until progression of cancer between groups

  End of follow-up maximum 18 months

• Patient satisfaction with their treatment between groups

  3 months

• Patient satisfaction with their treatment between groups

  6 months

• Patient satisfaction with their treatment between groups

  9 months

• Patient satisfaction with their treatment between groups

  12 months

Study Arms (2)

Prolife group

EXPERIMENTAL

scheduled consultation with the hospital clinical pharmacist, therapeutic follow-up and collection of clinical information by the patient via the THESS monitoring system

Other: THESS monitoring

Standard care

NO INTERVENTION

Interventions

THESS monitoring OTHER

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

Prolife group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

Centre Hospitalier Dubois Brive

Brive-la-Gaillarde, 19100, France

RECRUITING

Chic Castres-Mazamet

Castres, 81108, France

RECRUITING

Centre Hospitalier Emile ROUX

Le Puy-en-Velay, 43 012, France

RECRUITING

CHU de Nîmes

Nîmes, France

RECRUITING

Institut cancerologie du Gard

Nîmes, France

RECRUITING

Médipôle Lyon-Villeurbanne

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Frédéric Fiteni

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Fiteni

CONTACT

04.34.03.46.69; frederic.fiteni@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 26, 2022
• Study Start: September 16, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

FR (6)