Clinical trial NCT01531478: Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France
Official title: Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Sequels
Complications
Keywords: Childhood cancer
Cancer
Sequels
Complications
Chemotherapy
Radiotherapy
Surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2012-02-13
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective cohort study in non-leukemia cancer survivors diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France, who were younger than 15 years at the time of diagnosis

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Medical complications (post cancer treatment)
timeFrame: 15 years after the end of the cancer treatment
Secondary outcomes:
measure: MINI questionnaire score
timeFrame: 15 years after the end of the cancer treatment
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: IHOP
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Claire BERGER, MD
role: PRINCIPAL_INVESTIGATOR
References: