Information Consultation by Radiotherapy Manipulator

NCT02867462 | Completed Results

• 2 other identifiers: 2012/63 INFORTH2012-A01601-42
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• EORTC QLQ-INFO25

  Assesses the amount of information received by patients using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25) before the first radiotherapy session. The Global Information Score will be reported. According to the EORTC scoring manual, raw scores are linearly transformed into a standardized scale ranging from a minimum of 0 to a maximum of 100. Higher values represent a better outcome (a higher level of information received), while lower values represent a worse outcome. Data will be presented as the mean value and standard deviation (SD) for each randomization arm.

  12 weeks

Study Arms (2)

A-Standard Care

OTHER

standard care

Other: Standard care

B-manipulator consultation radiotherapy added to standard care

EXPERIMENTAL

manipulator consultation radiotherapy added to standard care

Other: manipulator consultation radiotherapy added to standard care

Interventions

Standard care OTHER

standard care

A-Standard Care

manipulator consultation radiotherapy added to standard care OTHER

B-manipulator consultation radiotherapy added to standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine LACASSAGNE

Nice, 0, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Centre Antoine Lacassagne

DRCI-Promotion@nice.unicancer.fr

+33 4 92 03 10 00

Study Officials

• Karen BENEZERY, md

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: April 1, 2013
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2017
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-06

Locations

FR (1)