Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 10, 2014
First Posted Date December 31, 2014
Last Update Posted Date October 31, 2016
Study Start Date January 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 29, 2014)
  • Hospital costs [ Time Frame: Up to 18 weeks ]
    Evaluate and compare between the 2 groups the total hospital costs
  • 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
  • Satisfaction measured by self-administered questionnaires [ Time Frame: Up to 18 weeks ]
    Evaluate and compare between the 2 groups patient and physicians satisfaction
  • Anxiety and depression measured by HADS scale [ Time Frame: Inclusion ]
    Compare baseline characteristics of the 2 groups (anxiety and depression)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients undergoing treatment with first-line IV chemotherapy
Condition Solid or Lymphoid Malignant Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 28, 2016)
44
Original Estimated Enrollment
 (submitted: December 29, 2014)
192
Study Completion Date Not Provided
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02328560
Other Study ID Numbers ANNONCEP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Francois Baclesse
Study Sponsor Centre Francois Baclesse
Collaborators Not Provided
Investigators
Principal Investigator: François GERNIER, health executive Centre François Baclesse
PRS Account Centre Francois Baclesse
Verification Date February 2016