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

Solid Tumors Clinical Trial

— EVAL'COACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619045
• Other study ID #: 14 GENE 07
• Status: Completed
• Phase: N/A
• First received: November 30, 2015
• Last updated: March 1, 2018
• Start date: November 9, 2015
• Est. completion date: June 21, 2017

Study information

• Verified date: March 2018
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Other:
• 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);

Locations

Country	Name	City	State
France	Institut claudius regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy : Proportion of patients for which there was a modification in their care through the nurse device		24 months
Secondary	Safety according to the classification of the CTCAE (Common for Toxicity Criteria for Adverse effects) V4.0		24 months
Secondary	Quality of life using the QLQ-C30 questionnaire and the Skindex®-16 questionnaire		24 months
Secondary	Cost of the follow-up nursing device for the establishing		24 months
Secondary	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