Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France (SALTO)
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|ClinicalTrials.gov Identifier: NCT01531478|
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : March 31, 2015
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.
|Condition or disease||Intervention/treatment|
|Cancer Sequels Complications||Other: Unique medical visit of the study|
|Study Type :||Observational|
|Actual Enrollment :||147 participants|
|Official Title:||Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Young adult survivors of childhood cancer
Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France.
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).
- Medical complications (post cancer treatment) [ Time Frame: 15 years after the end of the 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.
- MINI questionnaire score [ Time Frame: 15 years after the end of the cancer treatment ]The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531478
|CHU de Clermont-Ferrand|
|Clermont-ferrand, France, 63000|
|CHU de Grenoble|
|Grenoble, France, 38000|
|Lyon, France, 69000|
|CHU de Saint-Etienne|
|Saint-Etienne, France, 42000|
|Principal Investigator:||Claire BERGER, MD||CHU de Saint-Etienne|