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

Study Overview
=================
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.

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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: THESS monitoring


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolife group<br>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<br>* 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<br>|
| No Intervention: Standard care<br> | |

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 |