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OpenTrials
Completed

NCT Number: NCT02867462

Information Consultation by Radiotherapy Manipulator

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine LACASSAGNE

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

standard care

manipulator consultation radiotherapy added to standard care

Other

Primary outcomes

  1. EORTC QLQ-INFO25

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Official study title

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

Acronym: INFORTH

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 16, 2016
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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