Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France

Cancer Clinical Trial

— SALTO  

Official title:

Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531478
• Other study ID #: 1008102
• Secondary ID: 2010-A00853-36
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: March 30, 2015
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers.

The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.

Description:

Results will help identify long-term complications, respond to patients' expectations, and evaluate the feasibility of conducting such a follow-up in all patients. They should guide the choice of the most appropriate tools for care, help assess needs in terms of collaboration with adult care staff, and identify potential partners.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having been diagnosed with cancer between 01/01/1987 and 31/12/1992, before age 15, and living in Auvergne or Rhône-Alpes (France)

• Being a beneficiary of health insurance

• Having signed the informed consent form

Exclusion Criteria:

• Having been diagnosed with leukemia as a primary cancer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Complications
• Sequels

Intervention

Other:
• Unique medical visit of the study
The visit will be with an oncologist specialized in the long-term follow-up of cured pediatric cancer patients. The examination will consist in weight and height measurements, a clinical examination and a measurement of arterial pressure. The list of drugs taken in the last two years, as well as all health issues encountered since the cancer treatment, will be collected. Success in education, career and, family status will also be discussed. After the medical examination, patients will be offered a visit with a psychologist in order to assess their psychopathological outcomes. This questionnaire is a interquestionnaire designed to screen axis I psychopathological conditions. It includes an evaluation of all types of risk-taking behavior (alcohol, drugs, anorexia and bulimia).

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-ferrand
France	CHU de Grenoble	Grenoble
France	IHOP	Lyon
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical complications (post cancer treatment)	The investigators note the medical complications from the end of their cancer treatment to the inclusion visit. Theses complications depend on the type of treatment received.	15 years after the end of the cancer treatment	Yes
Secondary	MINI questionnaire score	The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.	15 years after the end of the cancer treatment	No