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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: THESS monitoring

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric Fiteni; Phone Number: 04.34.03.46.69; Email: frederic.fiteni@chu-nimes.fr

Study Locations

• France
  • Brive-la-Gaillarde, France, 19100
    • Recruiting
    • Centre Hospitalier Dubois Brive
    • Contact: Nicolas MADRANGES
    • Principal Investigator: Nicolas MADRANGES
  • Castres, France, 81108
    • Recruiting
    • Chic Castres-Mazamet
    • Contact: BOTIN
    • Principal Investigator: Teresa BOTIN
  • Le Puy en Velay, France, 43 012
    • Recruiting
    • Centre Hospitalier Emile Roux
    • Principal Investigator: Brigitte MONANGE
    • Contact: Brigitte MONANGE
  • Nîmes, France
    • Recruiting
    • CHU de Nîmes
    • Sub-Investigator: Géraldine LEGUELINEL BALCHE
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Frédéric Fiteni
  • Nîmes, France
    • Recruiting
    • Institut cancerologie du Gard
    • Contact: Eric Legouffe; Email: legouffe.oncogard@orange.fr
    • Principal Investigator: Eric Legouffe
  • Villeurbanne, France, 69100
    • Recruiting
    • Medipole Lyon-Villeurbanne
    • Contact: Marie BEGUINOT
    • Principal Investigator: Marie BEGUINOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• The subject is participating in a category 1 interventional study, or is in a period of 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, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
• Patient receiving hormone therapy alone for breast or prostate cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until progression of cancer between groups	Measured every 3 months by the Response Evaluation Criteria in Solid Tumours (RECIST) criteria, classed as: Complete response (CR), Partial response (PR), Stable disease (SD), or Progressive disease (PD)	End of follow-up maximum 18 months
Patient satisfaction with their treatment between groups	The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.	3 months
Patient satisfaction with their treatment between groups	The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.	6 months
Patient satisfaction with their treatment between groups	The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.	9 months
Patient satisfaction with their treatment between groups	The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.	12 months
Patient satisfaction with their treatment between groups	The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.	15 months
Patient satisfaction with their treatment between groups	The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.	18 months
Quality of life adjusted years between groups	EuroQol-5 Dimension (EQ5D-3L) questionnaire, presented as 5-digit number	18 months
Cost of care between groups	The cost of the system will be estimated from the point of view of the health care institution by valuing the time of the medical and nursing staff and patient out-of-pocket expenses	End of study (18 months)
Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	3 months
Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	6 months
Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	9 months
Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	12 months
Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	15 months
Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	18 months
Relative Dose Intensity between groups	% doses received/dose planned	3 months
Relative Dose Intensity between groups	% doses received/dose planned	6 months
Relative Dose Intensity between groups	% doses received/dose planned	9 months
Relative Dose Intensity between groups	% doses received/dose planned	12 months
Relative Dose Intensity between groups	% doses received/dose planned	15 months
Relative Dose Intensity between groups	% doses received/dose planned	18 months
Budget Impact Analysis	Cost of care for the population reached (actual population treated) on a national scale in Euros	After 2 years
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		3 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		6 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		9 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		12 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		15 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		18 months
Medication observance	Girerd questionnaire; score 0-6	3 months
Medication observance	Girerd questionnaire; score 0-6	6
Medication observance	Girerd questionnaire; score 0-6	9 months
Medication observance	Girerd questionnaire; score 0-6	12 months
Medication observance	Girerd questionnaire; score 0-6	15 months
Medication observance	Girerd questionnaire; score 0-6	18 months
Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes	System Usability Scale questionnaire; score 0-100	Month 18

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Frédéric Fiteni, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Mouth Neoplasms
• Other Study ID Numbers: PHRC-I/2019/FF-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No