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

Cancer Clinical Trial

— PROLIFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345587
• Other study ID #: PHRC-I/2019/FF-01
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: October 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Frédéric Fiteni
• Phone: 04.34.03.46.69
• Email: frederic.fiteni[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Mouth Neoplasms

Intervention

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

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life adjusted years between groups	EuroQol-5 Dimension (EQ5D-3L) questionnaire, presented as 5-digit number	18 months
Secondary	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)
Secondary	Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	3 months
Secondary	Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	6 months
Secondary	Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	9 months
Secondary	Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	12 months
Secondary	Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	15 months
Secondary	Toxicity experienced during treatment between groups	National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)	18 months
Secondary	Relative Dose Intensity between groups	% doses received/dose planned	3 months
Secondary	Relative Dose Intensity between groups	% doses received/dose planned	6 months
Secondary	Relative Dose Intensity between groups	% doses received/dose planned	9 months
Secondary	Relative Dose Intensity between groups	% doses received/dose planned	12 months
Secondary	Relative Dose Intensity between groups	% doses received/dose planned	15 months
Secondary	Relative Dose Intensity between groups	% doses received/dose planned	18 months
Secondary	Budget Impact Analysis	Cost of care for the population reached (actual population treated) on a national scale in Euros	After 2 years
Secondary	Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		3 months
Secondary	Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		6 months
Secondary	Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		9 months
Secondary	Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		12 months
Secondary	Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		15 months
Secondary	Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).		18 months
Secondary	Medication observance	Girerd questionnaire; score 0-6	3 months
Secondary	Medication observance	Girerd questionnaire; score 0-6	6
Secondary	Medication observance	Girerd questionnaire; score 0-6	9 months
Secondary	Medication observance	Girerd questionnaire; score 0-6	12 months
Secondary	Medication observance	Girerd questionnaire; score 0-6	15 months
Secondary	Medication observance	Girerd questionnaire; score 0-6	18 months
Secondary	Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes	System Usability Scale questionnaire; score 0-100	Month 18