Awareness on Cancer in Persons With Intellectual Disabilities

NCT02898363 | Completed

• 1 other identifier: AO-INCA/2012/DS-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in France, develop as many cancers as persons in the general population. However, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are associated with an intellectual disability) and above all the unusual clinical presentation. These cancers are not well known from physicians, carers and families, and often discovered late. A recent review of the literature shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of cancer in these patients. Currently, no population study on clinical features and stage at diagnosis of cancer in PWIDs is available. No interventional research study has been conducted on this subject. Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result from a direct link between intellectual disability and cancer, but are related to diagnosis difficulties of these tumors which are not well known, and to difficulties of communication with these patients who do not express easily their symptoms, particularly pain.

Conditions

Cancer

Keywords

Care of disabled population; Mental retardation; Cancer screening; Cancer prevention

Outcome Measures

Primary Outcomes (1)

• Cancer incidence among persons with intellectual disabilities

  Change from baseline (i.e. years -4 through -1) to years 1 through 3

Interventions

Information campaign OTHER

During a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in persons with intellectual disabilities by means of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in persons with intellectual disabilities.

Eligibility Criteria

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

Study Population

The study population is all adults with intellectual disabilities residing in the Hérault department of France who have been diagnosed with cancer

You may qualify if:

• Persons with intellectual disabilities according to the World Health Organization definition
• Residing in the Hérault department of France
• Diagnosis of a malign invasive or in-situ tumor

You may not qualify if:

• Refusal of study participation following provision of information (refusal by the patient, or his/her guardian, or principal caregiver)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique

Montpellier, 34093, France

Location

MeSH Terms

Conditions

Neoplasms; Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Daniel Satgé, MD, PhD

  IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: March 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

FR (1)