Cancer Clinical Trial
— SALTOOfficial title:
Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | National Cancer Institute, France |
France,
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 |
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