Clinical trial NCT05345587: Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy
Official title: Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time until decrease in quality of life by 5-points between groups
timeFrame: End of follow-up maximum 18 months
Secondary outcomes:
measure: Time until progression of cancer between groups
timeFrame: End of follow-up maximum 18 months
measure: Patient satisfaction with their treatment between groups
timeFrame: 3 months
measure: Patient satisfaction with their treatment between groups
timeFrame: 6 months
measure: Patient satisfaction with their treatment between groups
timeFrame: 9 months
measure: Patient satisfaction with their treatment between groups
timeFrame: 12 months
measure: Patient satisfaction with their treatment between groups
timeFrame: 15 months
measure: Patient satisfaction with their treatment between groups
timeFrame: 18 months
measure: Quality of life adjusted years between groups
timeFrame: 18 months
measure: Cost of care between groups
timeFrame: End of study (18 months)
measure: Toxicity experienced during treatment between groups
timeFrame: 3 months
measure: Toxicity experienced during treatment between groups
timeFrame: 6 months
measure: Toxicity experienced during treatment between groups
timeFrame: 9 months
measure: Toxicity experienced during treatment between groups
timeFrame: 12 months
measure: Toxicity experienced during treatment between groups
timeFrame: 15 months
measure: Toxicity experienced during treatment between groups
timeFrame: 18 months
measure: Relative Dose Intensity between groups
timeFrame: 3 months
measure: Relative Dose Intensity between groups
timeFrame: 6 months
measure: Relative Dose Intensity between groups
timeFrame: 9 months
measure: Relative Dose Intensity between groups
timeFrame: 12 months
measure: Relative Dose Intensity between groups
timeFrame: 15 months
measure: Relative Dose Intensity between groups
timeFrame: 18 months
measure: Budget Impact Analysis
timeFrame: After 2 years
measure: Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
timeFrame: 3 months
measure: Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
timeFrame: 6 months
measure: Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
timeFrame: 9 months
measure: Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
timeFrame: 12 months
measure: Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
timeFrame: 15 months
measure: Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
timeFrame: 18 months
measure: Medication observance
timeFrame: 3 months
measure: Medication observance
timeFrame: 6
measure: Medication observance
timeFrame: 9 months
measure: Medication observance
timeFrame: 12 months
measure: Medication observance
timeFrame: 15 months
measure: Medication observance
timeFrame: 18 months
measure: Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes
timeFrame: Month 18
Other outcomes:
Locations:
city: Brive-la-Gaillarde
country: France
facility: Centre Hospitalier Dubois Brive
city: Castres
country: France
facility: Chic Castres-Mazamet
city: Le Puy en Velay
country: France
facility: Centre Hospitalier Emile ROUX
city: Nîmes
country: France
facility: CHU de Nîmes
city: Nîmes
country: France
facility: Institut cancerologie du Gard
city: Villeurbanne
country: France
facility: Médipôle Lyon-Villeurbanne
Study officials:
affiliation: CHU de Nimes
name: Frédéric Fiteni
role: PRINCIPAL_INVESTIGATOR
References: