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

NCT ID: NCT02675166

Last Updated: 2018-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-23

Study Completion Date

2018-03-01

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer Sequels Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric cancer young adult survivors

544 patients alive and that are min 18 years old, included in the ARCERRA population register, for a primary cancer (not leukemia), diagnosed between 15 years old, between January the 1st 1993, and December the 31st 1999, in Rhône-Alpes.

Pediatric cancer young adult survivors

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Long term follow up

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BERGER Claire, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Léonie CASAGRANDA, PhD

Role: STUDY_CHAIR

CHU SAINT-ETIENNE

Locations

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Chu Grenoble

Grenoble, , France

Site Status

IHOP1 de Lyon

Lyon, , France

Site Status

CH Lyon Sud - Pierre Bénite

Lyon, , France

Site Status

Chu Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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Tardy F, Casagranda L, Protiere A, Buisson-Papet G, Garcin A, Trombert-Paviot B, Freycon C, Marec-Berard P, Massoubre C, Berger C. Long-Term Clinical and Psychiatric Complications of Young Adults Cured of a Pediatric Bone Tumor Diagnosed Between 1987 and 1999 in Rhone: Alpes Region (France). J Adolesc Young Adult Oncol. 2022 Dec;11(6):571-579. doi: 10.1089/jayao.2021.0145. Epub 2022 Jan 18.

Reference Type DERIVED
PMID: 35049375 (View on PubMed)

Other Identifiers

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2015-A00656-43

Identifier Type: OTHER

Identifier Source: secondary_id

1508056

Identifier Type: -

Identifier Source: org_study_id

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