Information Consultation by Radiotherapy Manipulator

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Standard care; Other: manipulator consultation radiotherapy added to standard care

• Registration Number: NCT02867462
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Primary Completion: 2017-05-10
• Study Completion: 2017-05-10
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A-Standard Care	Standard care	standard care
B-manipulator consultation radiotherapy added to standard care	manipulator consultation radiotherapy added to standard care	manipulator consultation radiotherapy added to standard care

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-INFO25	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

Trial Locations

Locations (1)

Centre Antoine LACASSAGNE; 🇫🇷 Nice, France