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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02867462
Other study ID # 2012/63 INFORTH
Secondary ID
Status Completed
Phase N/A
First received August 11, 2016
Last updated November 30, 2017
Start date April 2013
Est. completion date May 10, 2017

Study information

Verified date August 2016
Source Centre Antoine Lacassagne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 308
Est. completion date May 10, 2017
Est. primary completion date May 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Standard care
standard care
manipulator consultation radiotherapy added to standard care


Locations

Country Name City State
France Centre Antoine LACASSAGNE Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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