Information Consultation by Radiotherapy Manipulator (INFORTH)

Information Consultation by a Manipulator Radiotherapy: Impact on Information to Patients Treated With Radiotherapy for Cancer

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Standard care; Other: manipulator consultation radiotherapy added to standard care

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Centre Antoine Lacassagne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC QLQ-INFO25	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	12 weeks

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne
• Investigators: Principal Investigator: Karen BENEZERY, md, Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): May 10, 2017
• Study Completion (Actual): May 10, 2017

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2012/63 INFORTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED