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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Solid Tumors
- Sponsor
- Institut Claudius Regaud
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Efficacy : Proportion of patients for which there was a modification in their care through the nurse device
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Efficacy : Proportion of patients for which there was a modification in their care through the nurse device
Time Frame: 24 months
Secondary Outcomes
- Cost of the follow-up nursing device for the establishing(24 months)
- Medical costs(24 months)
- 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)