Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy

Terminated

• Conditions: Solid or Lymphoid Malignant Disease

• Registration Number: NCT02328560
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

The project aims primarily to measure the expected paramedic consultation announcement benefits for the patient, at different levels. It will measure improvements in the management of patients treated with chemotherapy. Indeed, paramedical consultation ad aims to provide a better understanding of the disease and treatment incurred, which should lead to the implementation of joint strategies between the healthcare team and the patient to prevent the effects of and treatment of the disease by the patient and caregivers.

This improvement is to promote the fair treatment by reducing patient anxiety and / or carers and involving them in the management of their disease. In this context, it is shown a profit of paramedical consultation for the patient, it will work, based on the recommendations of the Cancer Plan, strengthen the need to routinely offer paramedic Ad consultation.

This work should also help measure the impact of ad paramedical consultation on optimizing care consumption off-line therapy and to assess the associated costs.

For patients who received paramedic ad or not consultation, it will therefore be of particular compare intercurrent hospitalizations, commuting structure of care, the number of consultations with the doctor, the reports of cure, additional biological monitoring or other health care consumption.

With the participation of several centers in the fight against cancer, this study will provide valuable information on the practice of paramedical consultation ad in several tumor sites.

It will objectify the benefit provided by the Medical device announcement for both patients and the organization and use of care prerequisite to encourage better integration of this device in the course of patient care, the consultation paramedical ad remaining poorly understood by many health professionals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Study Start: 2016-01
• Status Verified: 2016-02
• Primary Completion: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 18 ≤ age <75 years;
• WHO ≤ 1;
• Patients with cancer and candidate for chemotherapy treatment of first intention;
• Solid or lymphoid malignant disease pathology for which chemotherapy is given intravenously;
• Patient affiliated to a social security scheme;
• Mastery of the French language;
• Informed Consent and signed;
• In the first cohort, patients will have received paramedical consultation announcement in the days preceding the first cycle of chemotherapy;
• In the second cohort, patients have not received paramedical consultation announcement.

Exclusion Criteria

• Patient deprived of liberty, under guardianship;
• Any medical or psychological condition associated that could compromise the patient's ability to participate in the study;
• Exclusive Oral Chemotherapy;
• Exclusive Targeted therapy;
• Targeted therapy to be introduced during chemotherapy;
• Presence of cerebral localization;
• Pain requiring analgesics bearing 3;
• Patient in medical and social structure;
• Inability to submit to medical monitoring test for geographical, social or psychological reasons;
• Rare Cancers making matching difficult (sarcomas of soft tissue and internal organs, malignant neuroendocrine tumors sporadic and hereditary rare ...)
• Inclusion in another clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Care consumption	Up to 18 weeks	Compare among patients candidates for chemotherapy treatment IV first line, the proportions of patients who need more care than anticipated during the first cycle of chemotherapy among patients who have had paramedical announcement of consultation and those who have not had.

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression measured by HADS scale	Inclusion	Compare baseline characteristics of the 2 groups (anxiety and depression)
Hospital costs	Up to 18 weeks	Evaluate and compare between the 2 groups the total hospital costs
Number of patients with adverse events	Up to 18 weeks	Evaluate and compare between the 2 groups the health care consumption and side effects of chemotherapy
Satisfaction measured by self-administered questionnaires	Up to 18 weeks	Evaluate and compare between the 2 groups patient and physicians satisfaction

Trial Locations

Locations (1)

Centre François BACLESSE; 🇫🇷 Caen, France