Clinical trial NCT02328560: Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy
Official title: Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Solid or Lymphoid Malignant Disease
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing treatment with first-line IV chemotherapy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Care consumption
timeFrame: Up to 18 weeks
Secondary outcomes:
measure: Hospital costs
timeFrame: Up to 18 weeks
measure: Number of patients with adverse events
timeFrame: Up to 18 weeks
measure: Satisfaction measured by self-administered questionnaires
timeFrame: Up to 18 weeks
measure: Anxiety and depression measured by HADS scale
timeFrame: Inclusion
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François BACLESSE
Study officials:
affiliation: Centre François Baclesse
name: François GERNIER, health executive
role: PRINCIPAL_INVESTIGATOR
References: