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

NCT ID: NCT02619045

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-09
• Study Completion Date: 2017-06-21

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Solid tumors

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

Group Type: OTHER

Telephone follow-up nursing device

Intervention Type: OTHER

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);

Interventions

Telephone follow-up nursing device

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);

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre DELORD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

Institut claudius regaud

Toulouse, , France

Countries

France

Other Identifiers

14 GENE 07

Identifier Type: -

Identifier Source: org_study_id