Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment (EVAL'COACH)

Institut Claudius Regaud

Status: Completed

Conditions: Solid Tumors

Treatments: Other: Telephone follow-up nursing device

Study type: Interventional

Funder types: Other

Identifiers

NCT02619045

14 GENE 07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with a solid tumor.
2. Patient starting a first cycle of chemotherapy (+ - targeted therapy).
3. Patient starting intravenous chemotherapy including 21-day cycles.
4. Patient ≥18 years old.
5. Patient affiliated to a social security system in France.
6. Patient who signed the informed consent before study inclusion and before any study specific procedure.

Exclusion criteria

1. Patient already included in another interventional biomedical research.
2. Patient who began intravenous chemotherapy.
3. Patient who must receive an oral chemotherapy.
4. Patient who must be treated with a weekly chemotherapy or with concomitant radiotherapy.
5. Patient unreachable by phone.
6. Patient with no caregiver who can answer the phone in his place.
7. Pregnant or breastfeeding women.
8. Any psychological condition, family, geographic or social not to comply with medical monitoring and / or procedures in the study protocol.
9. Patient protected by law.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Solid tumors

Other group

Description:

Patients with solid tumor starting a intra venous chemotherapy with 21 days cycles.

Treatment:

Other: Telephone follow-up nursing device