Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Information Consultation by Radiotherapy Manipulator (INFORTH)

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: NCT02867462
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief Summary:

The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.

This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.

In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.

The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.


Condition or disease Intervention/treatment Phase
Cancer Other: Standard care Other: manipulator consultation radiotherapy added to standard care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Information Consultation by a Manipulator Radiotherapy: Impact on Information to Patients Treated With Radiotherapy for Cancer
Actual Study Start Date : April 2013
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 10, 2017

Arm Intervention/treatment
A-Standard Care
standard care
Other: Standard care
standard care

Experimental: B-manipulator consultation radiotherapy added to standard care
manipulator consultation radiotherapy added to standard care
Other: manipulator consultation radiotherapy added to standard care



Primary Outcome Measures :
  1. EORTC QLQ-INFO25 [ Time Frame: 12 weeks ]
    amount of information received by patients in the case of a standard support and if the patient has a consultation with a radiation therapy manipulator, assessed using the questionnaire EORTC QLQ-INFO25 before the first radiotherapy session



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cancer of the head and neck, esophagus, stomach, breast, rectum, anal canal, prostate, lung, bile duct, pancreas or female genital histologically proven
  • Patient being treated by radiotherapy alone or combined with chemotherapy / immunotherapy, exclusive treatment or adjuvant
  • Age over 18 years

Exclusion Criteria:

  • Patient has been treated with radiation to the tumor site
  • Patient with metastatic stage disease
  • Patient targeted for hypofractionated radiotherapy

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): NCT02867462


Locations
Layout table for location information
France
Centre Antoine LACASSAGNE
Nice, France, 0
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Layout table for investigator information
Principal Investigator: Karen BENEZERY, md Centre Antoine Lacassagne

Layout table for additonal information
Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT02867462     History of Changes
Other Study ID Numbers: 2012/63 INFORTH
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided