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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Other: Telephone follow-up nursing 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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Institut Claudius Regaud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Solid tumors; Patients with solid tumor starting a intra venous chemotherapy with 21 days cycles.

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);

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cost of the follow-up nursing device for the establishing		24 months
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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Investigators: Principal Investigator: Jean-Pierre DELORD, PhD, Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2015
• Primary Completion (Actual): June 21, 2017
• Study Completion (Actual): June 21, 2017

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 14 GENE 07