Clinical trial NCT02675166: Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Official title: SALTO -2 ( Long Term Monitoring In Oncology ) : Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes, Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Sequels
Complications
Keywords: Childhood cancer
Sequels
Complications
Surgery
Radiotherapy
Chemotherapy
Cancer
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 137
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: The study population is composed of 544 patients registered in the ARCERRA documùent. They survived at a pediatric cancer, diagnosed in Rhône-Alpes between January the 1st 1993 and December the 31st 1999. They were less than 15 years old during this period.

Brief summary: Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is estimated as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical complications can lead to a late risk of death. A regularly support, a therapeutic education, a support of the psychological difficulties have a positive impact on the quality of life and on long-term health for patients surviving to a cancer.

The ARCERRA exists, registering around 150 new cases a year. They coordinated, from 2011 to 2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility and utility for patients and their physicians of a long-term follow-up coupled with an interview with a psychologist in Rhône-Alpes-Auvergne.

The primary objective of SALTO-2 project is to know the becoming of young adults that survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second objective is in one hand to study the psychological becoming and on another hand, to ameliorate their lifestyle thanks to different documents created specially for them.

Detailed description: Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is considered as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical complications can lead to a late risk of death estimated in literature at 14%. A regularly support, a therapeutic education, a support of the psychological difficulties have a positive impact on the quality of life and on long-term health for patients surviving to a cancer. Many countries developed structures able to take care for a long term this kind of patients. In France, such structures are going to be developed.

The register of cancers concerning children of Rhône-Alpes (ARCERRA) exists since 1987, registering around 150 new cases a year. They coordinated, from 2011 to 2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility and utility for patients and their physicians of a long-term follow-up coupled with an interview with a psychologist in Rhône-Alpes-Auvergne.

The primary objective of SALTO-2 project is to know the becoming of young adults that survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second objective is in one hand to study the psychological becoming and on another hand, to ameliorate their lifestyle thanks to different documents created specially for them.

This is a prospective cohort study of patients surviving cancer (excluding leukemia) diagnosed between 1993 and 1999 in the Rhône- Alpes region before age 15 years. A questionnaire concerning their general situation and their professional life, their shape, and their quality of life will be sent to them. A consultation with an oncologist and an internist if possible will be planned. The two physicians will adapt the consultation according to the SFCE (French society of struggle against cancers and leukemia of children and teenagers) recommendations. They will give the two SFCE's documents.

After that, a consultation with a psychologist will be proposed, with a questionnaire MINI evaluating psychological aspect.

Two years later, a new questionnaire will be delivered to the patients, to check the new events during this period. It will be added to a satisfaction survey, allowing the measure of documents' impact.

The results will allow the description of the long term impacts for these patients, to answer their eventually questions.

Eligibility criteria: Inclusion Criteria:

* Had a cancer diagnostic between January the 1st 1993 and December the 31st 1999, before the age of 15 years old, in Rhône-Alpes
* 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
measure: MINI questionnaire score
timeFrame: 17 years after the end of the cancer treatment
measure: Quality of life : SF-36 scale
timeFrame: 15 years after the end of the cancer treatment
measure: Quality of life : SF-36 scale
timeFrame: 17 years after the end of the cancer treatment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble
city: Lyon
country: France
facility: IHOP1 de Lyon
city: Lyon
country: France
facility: CH Lyon Sud - Pierre Bénite
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: BERGER Claire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SAINT-ETIENNE
name: Léonie CASAGRANDA, PhD
role: STUDY_CHAIR
References: