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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Sequels; Complications
• Intervention / Treatment: Other: Unique medical visit of the study

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 Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Grenoble, France, 38000
    • CHU de Grenoble
  • Lyon, France, 69000
    • IHOP
  • Saint-Etienne, France, 42000
    • Chu de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: National Cancer Institute, France
• Investigators: Principal Investigator: CLAIRE BERGER, MD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Cancer; Surgery; Radiotherapy; Chemotherapy; Childhood cancer; Sequels; Complications
• Other Study ID Numbers: 1008102; 2010-A00853-36 (Other Identifier: AFSSAPS)