Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes

Pediatric Cancer Clinical Trial

— SALTO-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675166
• Other study ID #: 1508056
• Secondary ID: 2015-A00656-43
• Status: Completed
• Start date: October 23, 2015
• Est. completion date: March 1, 2018

Study information

• Verified date: October 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complications
• Pediatric Cancer
• Sequels

Intervention

Other:
• Pediatric cancer young adult survivors
Patients will receive a questionnaire, a consultation with an oncologist and a psychologist will be planned, and two years later, patients will have to answer again to the questionnaire.

Locations

Country	Name	City	State
France	Chu Grenoble	Grenoble
France	CH Lyon Sud - Pierre Bénite	Lyon
France	IHOP1 de Lyon	Lyon
France	Chu Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	MINI questionnaire score	The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.	17 years after the end of the cancer treatment
Secondary	Quality of life : SF-36 scale	Researchers will focus on the quality of life (measured with the SF-36 scale).	15 years after the end of the cancer treatment
Secondary	Quality of life : SF-36 scale	Researchers will focus on the quality of life (measured with the SF-36 scale).	17 years after the end of the cancer treatment