Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment

Study Overview
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Brief Summary
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This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this Follow-up Program Device.

Detailed Description
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This study is a monocentric prospective cohort study designed to monitor the care of patients undergoing an intra venous chemotherapy. Patients with a solid tumor (200 patients in total), starting a first cycle of intravenous chemotherapy with 21 days cycle will be included in this study. Patients will be followed all over the chemotherapy period through regular and defined telephone appointments carried out by a dedicated nurse. During phone call, a specific questionnaire will be used in order to retrieve data regarding patients toxicities, general care, quality of life, ...Actions taken following each phone call will also be documented (consultation, hospitalization, prescription,...). The main objective of this study is to evaluate the impact of this telephone follow-up program on the care of patients under chemotherapy treatment. In addition, a medico-economic analysis of this device compared with historical data from the national database SNIIRAM will be done.

Official Title
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Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in Their Quality of Life and Medico-economic Analysis of This Follow-up Program Device

Conditions
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Solid Tumors

Intervention / Treatment
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* Other: Telephone follow-up nursing device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a solid tumor. Patient starting a first cycle of chemotherapy (+ - targeted therapy). Patient starting intravenous chemotherapy including 21-day cycles. Patient ≥18 years old. Patient affiliated to a social security system in France. Patient who signed the informed consent before study inclusion and before any study specific procedure. Exclusion Criteria: Patient already included in another interventional biomedical research. Patient who began intravenous chemotherapy. Patient who must receive an oral chemotherapy. Patient who must be treated with a weekly chemotherapy or with concomitant radiotherapy. Patient unreachable by phone. Patient with no caregiver who can answer the phone in his place. Pregnant or breastfeeding women. Any psychological condition, family, geographic or social not to comply with medical monitoring and / or procedures in the study protocol. Patient protected by law.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Solid tumors<br>Patients with solid tumor starting a intra venous chemotherapy with 21 days cycles. | Other: Telephone follow-up nursing device<br>* Telephone follow-up nursing device involving: telephone appointments made by a dedicated nurse and set up at key stage of treatment (1 phone call per week during chemotherapy cycles), specific questionnaire used by the nurse at each phone call (toxicity, general care, quality of life...), actions taken for the patient following each phone call (consultation with a doctor, patient hospitalization, sending of a prescription, coordination with the city medical caregiver);<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : Proportion of patients for which there was a modification in their care through the nurse device |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety according to the classification of the CTCAE (Common for Toxicity Criteria for Adverse effects) V4.0 |  | 24 months | 
| Quality of life using the QLQ-C30 questionnaire and the Skindex®-16 questionnaire |  | 24 months | 
| Cost of the follow-up nursing device for the establishing |  | 24 months | 
| Medical costs | Direct medical and non-medical costs of patients with malignant disease and followed by COACH will be compared to those of patients with the same types of cancer pathologies with traditional monitoring | 24 months |