SALTO-2: Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02675166

Collaborator

(none)

137

Enrollment

Locations

28.3

Actual Duration (Months)

34.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer Sequels Complications	Other: Pediatric cancer young adult survivors

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.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

137 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Oct 23, 2015

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Other Names: Long term follow up

Arm

Intervention/Treatment

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.

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.

Other Names:

Long term follow up

Outcome Measures

Primary Outcome Measures

Medical complications (post cancer treatment) [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

MINI questionnaire score [15 years after the end of the cancer treatment]
The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.
MINI questionnaire score [17 years after the end of the cancer treatment]
The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.
Quality of life : SF-36 scale [15 years after the end of the cancer treatment]
Researchers will focus on the quality of life (measured with the SF-36 scale).
Quality of life : SF-36 scale [17 years after the end of the cancer treatment]
Researchers will focus on the quality of life (measured with the SF-36 scale).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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