Hematopoietic Stem Cell Transplantation and Childhood Leukemia Quality of Life in SIbling DONors

NCT03659071 | Unknown

• 1 other identifier: RCAPHM17_0169
• Study Type: interventional
• Target: 1,187
• Locations: 1 country
• Sites: 1

Brief Summary

The childhood cancer experience necessarily impacts the entire family. In this context, particular attention should be paid to the donor siblings of hematopoietic stem cells in the context of treatment of leukemia by grafting. The results of the little existing work on the long-term fate of stem cell donor siblings of cancer survivors report psychosocial consequences, particularly for real post-traumatic stress in distant siblings. Few studies have explored the medium and long-term impact of the disease, as well as donation, on a broader set of domains structuring the quality of life, through validated quantitative tools. In France, since 2004, the LEA program (Leukemia of the Child and Adolescent) aims to assess the determinants of the state of health and quality of life in the medium and long term, patients treated for acute childhood leukemia after 1980. The main objective of this study is to evaluate, at a distance from the transplant, the quality of life of donors from the siblings of survivors of acute childhood leukemia who received a hematopoietic stem cell transplant compared with non-donor siblings. The SIDONY ancillary study will be proposed to families of LEA patients who have received a geno-identical sibling haematopoietic stem cell transplant (population of interest) and to families whose LEA patient has not been treated by sibling transplantation. geno-identical but still declaring to have siblings (main comparator group). Each family will be contacted by mail and the management of inclusions will be managed by the Epidemiology and Health Economics Department of AP-HM (Marseille). Information not routinely available in the LEA database will be collected from the siblings (self-questionnaire, in addition, for each surviving child included in the cohort, data are available: sociodemographic; characteristics of the initial disease and therapeutic received; physical sequelae; quality of life. The population meeting the inclusion criteria represents 2639 subjects: 337 donors and 2302 non-donors, making it possible to obtain high powers for analyzes (linear regression, multilevel analyzes, etc.). This study could identify profiles of siblings for whom the quality of life seems particularly impaired, potential object of individual interventions (remediation ...).

Conditions

Hematopoietic/Lymphoid Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of life scores

  VSPA questionnaire score Each item is rated from 1 to 5, depending on the answer: * Never / not at all, * arement / a little * sometimes / medium * some / many * Always enormously The scores were calculated according to the algorithm defined by the author of the questionnaire: the score of each dimension was obtained from the average of the answers given for the items of the dimension concerned. Scores range from 0 (the worst quality of life) to 100 (the best).

  1 day

Study Arms (2)

DONORS

EXPERIMENTAL

donors from the siblings of survivors of acute childhood leukemia who have received hematopoietic stem cell transplantation questionnaire VSP-A will be performed

Other: questionnaire VSP-A

NON DONORS

OTHER

non-donor siblings. questionnaire VSP-A will be performed

Other: questionnaire VSP-A

Interventions

questionnaire VSP-A OTHER

VSP-A (écu et Santé Perçue de l'Adolescent et de l'enfant): Lived and perceived health of the adolescent and child developed from the exclusive point of view of the child, for which reference values in French population are available. The self-questionnaire used is a questionnaire developed and validated in French for children and adolescents, according to the standards in force, apprehending 9 dimensions (vitality, psychological well-being, relations with friends, leisure, family relations, good physical, relationships with teachers, school work, self-esteem)

DONORS; NON DONORS

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• experimental group familly:
• child included in the LEA cohort
• having received allogeneic treatment of geno-identical sibling haematopoietic stem cells
• be the brother (or sister) donor of hematopoietic stem cells
• currently at least 8 years old
• give consent to participate in the study
• be allowed to participate in the study by his parents or legal representatives
• Control group familly
• child included in the LEA cohort
• who did not benefit from allogeneic hematopoietic stem cell transplantation of geno-identical siblings
• and declaring having a sibling
• currently at least 8 years old
• to be the closest brother (or sister) in the LEA patient's age (in the case of multiple siblings)
• give consent to participate in the study
• be allowed to participate in the study by his parents or legal representatives In order to respect the balance within the family, a questionnaire may be distributed to other brothers and sisters who claim it.

You may not qualify if:

• not to be allowed to participate in the study by his parents or legal representatives

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

JULIE BERBIS, MD

CONTACT

+33 491366.025; Julie.BERBIS@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 6, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: September 6, 2018

Record last verified: 2018-08

Locations

FR (1)