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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
196
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
Centre Hospitalier Dubois Brive
Brive-la-Gaillarde, France
RECRUITINGChic Castres-Mazamet
Castres, France
RECRUITINGCentre Hospitalier Emile ROUX
Le Puy-en-Velay, France
RECRUITINGCHU de Nîmes
Nîmes, France
RECRUITINGInstitut cancerologie du Gard
Nîmes, France
RECRUITINGMédipôle Lyon-Villeurbanne
Villeurbanne, France
RECRUITINGTime 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
Time frame: End of follow-up maximum 18 months
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Quality of life adjusted years between groups
EuroQol-5 Dimension (EQ5D-3L) questionnaire, presented as 5-digit number
Time frame: 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
Time frame: End of study (18 months)
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 3 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 6 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 9 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 12 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 15 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 18 months
Relative Dose Intensity between groups
% doses received/dose planned
Time frame: 3 months
Relative Dose Intensity between groups
% doses received/dose planned
Time frame: 6 months
Relative Dose Intensity between groups
% doses received/dose planned
Time frame: 9 months
Relative Dose Intensity between groups
% doses received/dose planned
Time frame: 12 months
Relative Dose Intensity between groups
% doses received/dose planned
Time frame: 15 months
Relative Dose Intensity between groups
% doses received/dose planned
Time frame: 18 months
Budget Impact Analysis
Cost of care for the population reached (actual population treated) on a national scale in Euros
Time frame: After 2 years
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 3 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 6 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 9 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 12 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 15 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 18 months
Medication observance
Girerd questionnaire; score 0-6
Time frame: 3 months
Medication observance
Girerd questionnaire; score 0-6
Time frame: 6
Medication observance
Girerd questionnaire; score 0-6
Time frame: 9 months
Medication observance
Girerd questionnaire; score 0-6
Time frame: 12 months
Medication observance
Girerd questionnaire; score 0-6
Time frame: 15 months
Medication observance
Girerd questionnaire; score 0-6
Time frame: 18 months
Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes
System Usability Scale questionnaire; score 0-100
Time frame: Month 18
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