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

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ClinicalTrials.gov Identifier: NCT02328560
Recruitment Status : Terminated (Loss of recrutement)
First Posted : December 31, 2014
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Solid or Lymphoid Malignant Disease

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy
Study Start Date : January 2016
Actual Primary Completion Date : October 2016

Group/Cohort
Paramedical ad consultation
Monitoring will be the same in the 2 groups; That paramedical consultation announcement is made in current practice.
No paramedical ad consultation
Monitoring will be the same in the 2 groups



Primary Outcome Measures :
  1. Care consumption [ Time Frame: 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 :
  1. Hospital costs [ Time Frame: Up to 18 weeks ]
    Evaluate and compare between the 2 groups the total hospital costs

  2. Number of patients with adverse events [ Time Frame: Up to 18 weeks ]
    Evaluate and compare between the 2 groups the health care consumption and side effects of chemotherapy

  3. Satisfaction measured by self-administered questionnaires [ Time Frame: Up to 18 weeks ]
    Evaluate and compare between the 2 groups patient and physicians satisfaction

  4. Anxiety and depression measured by HADS scale [ Time Frame: Inclusion ]
    Compare baseline characteristics of the 2 groups (anxiety and depression)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing treatment with first-line IV chemotherapy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328560


Locations
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France
Centre François BACLESSE
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
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Principal Investigator: François GERNIER, health executive Centre François Baclesse
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02328560    
Other Study ID Numbers: ANNONCEP
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: February 2016