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

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

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

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.

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

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

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

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)

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.

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.

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.

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.

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.

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.

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

Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

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