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

SALTO -2 ( Long Term Monitoring In Oncology ) : Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes, Multicentric Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02675166
Acronym
SALTO-2
Enrollment
137
Registered
2016-02-05
Start date
2015-10-23
Completion date
2018-03-01
Last updated
2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Pediatric Cancer, Sequels

Keywords

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

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.

Interventions

OTHERPediatric 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medical complications (post cancer treatment)15 years after the end of the cancer treatmentThe 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

MeasureTime frameDescription
MINI questionnaire score15 years after the end of the cancer treatmentThe investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.
Quality of life : SF-36 scale15 years after the end of the cancer treatmentResearchers will focus on the quality of life (measured with the SF-36 scale).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026