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

• ClinicalTrials.gov Identifier: NCT01531478
• Recruitment Status: Completed
• First Posted: February 13, 2012
• Last Update Posted: March 31, 2015
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborator: National Cancer Institute, France
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Study Description

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.

Condition or disease	Intervention/treatment
Cancer; Sequels; Complications	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 Design

• Study Type: Observational
• Actual Enrollment: 147 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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

Groups and Cohorts

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).

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

CHU de Clermont-Ferrand

Clermont-ferrand, France, 63000

CHU de Grenoble

Grenoble, France, 38000

IHOP

Lyon, France, 69000

CHU de Saint-Etienne

Saint-Etienne, France, 42000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

National Cancer Institute, France

Investigators

• Principal Investigator: Claire BERGER, MD; CHU de Saint-Etienne

More Information

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT01531478
• Other Study ID Numbers: 1008102; 2010-A00853-36 ( Other Identifier: AFSSAPS )
• First Posted: February 13, 2012
• Last Update Posted: March 31, 2015
• Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

Childhood cancer; Cancer; Sequels; Complications; Chemotherapy; Radiotherapy; Surgery