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

Completed

• Conditions: Sequels; Complications; Cancer
• Interventions: Other: Unique medical visit of the study

• Registration Number: NCT01531478
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-13
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young adult survivors of childhood cancer	Unique medical visit of the study	Young adult survivors of childhood cancer diagnosed between 1987 and 1992 in the Rhône-Alpes and Auvergne regions of France.

Primary Outcome Measures

Name	Time	Method
Medical complications (post cancer treatment)	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.

Secondary Outcome Measures

Name	Time	Method
MINI questionnaire score	15 years after the end of the cancer treatment	The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.

Trial Locations

Locations (4)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

IHOP; 🇫🇷 Lyon, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France