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

Not Applicable

Completed

• Conditions: Solid Tumors
• Interventions: Other: Telephone follow-up nursing device

• Registration Number: NCT02619045
• Lead Sponsor: Institut Claudius Regaud

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.

Study Timeline

• Study Start: 2015-11-09
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-02
• Primary Completion: 2017-06-21
• Study Completion: 2017-06-21
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solid tumors	Telephone follow-up nursing device	Patients with solid tumor starting a intra venous chemotherapy with 21 days cycles.

Primary Outcome Measures

Name	Time	Method
Efficacy : Proportion of patients for which there was a modification in their care through the nurse device	24 months

Secondary Outcome Measures

Name	Time	Method
Cost of the follow-up nursing device for the establishing	24 months
Medical costs	24 months	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
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

Trial Locations

Locations (1)

Institut claudius regaud; 🇫🇷 Toulouse, France