Clinical Trials Logo

Clinical Trial 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 ...).


Clinical Trial Description

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. disease. 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 (medical, socio-economic, behavioral and environmental) of the state of health and quality of life in the medium and long term, patients treated for acute childhood leukemia after 1980. To document the quality of life of their self-reported hematopoietic stem cell donor siblings and their perception of the impact that experience of cancer in the family has had on their medium and long-term future, the organization of the LEA program can easily be extended to the establishment of an ancillary study.

objectives 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 secondary objectives are: (a) to compare the quality of life of siblings with that of the general population; (b) to compare the quality of life of the siblings with that of the surviving patients; (c) to identify the determinants (demographic, socioeconomic, family and history of cancer) of the medium-long-term quality of life of this family; (d) remotely evaluate the donation's use of the donor sire care system as a tracer of the impact of the donation; (e) remotely evaluate the gift of the social integration of the donor sibship, particularly in terms of schooling.

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, to be returned by post): sociodemographic and socio-economic data relating to the siblings and the family; data concerning the quality of life of the siblings; psycho-behavioral and cognitive data; data on the state of health of the siblings; social inclusion data; recourse to the health care system. 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.

Feasibility and practical impact 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 ...). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03659071
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact JULIE BERBIS, MD
Phone +33 491366.025
Email Julie.BERBIS@ap-hm.fr
Status Not yet recruiting
Phase N/A
Start date December 2018
Completion date May 2020

See also
  Status Clinical Trial Phase
Recruiting NCT02903810 - Combination Transfer of αCD19-TCRz-41BB and αCD22-TCRz-41BB CAR-T Cells for B-cell Hematologic Malignancy Phase 1/Phase 2
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Active, not recruiting NCT01056614 - Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies Phase 2
Terminated NCT00089089 - Decitabine in Treating Patients With Advanced Refractory Solid Tumors or Lymphomas Phase 1
Completed NCT03654404 - A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients N/A
Completed NCT01212380 - Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) or Prolymphocytic Leukemia (PLL) Phase 1
Completed NCT00896792 - Nurse Practitioner Hospice Program for Patients With Terminal Metastatic Cancer and Their Families or Caregivers Early Phase 1
Recruiting NCT03110640 - Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma Phase 1
Completed NCT01982682 - Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor Phase 2
Completed NCT00833898 - Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT) Phase 3
Active, not recruiting NCT05147311 - Positive Psychology Intervention In HSCT N/A
Completed NCT04172818 - Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families N/A
Completed NCT00670917 - Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy N/A
Withdrawn NCT00899808 - Molecular Markers and Genetic Markers in Patients Undergoing Radiation Therapy for Cancer N/A
Recruiting NCT02081937 - CART-19 Immunotherapy in Mantle Cell Lymphoma Phase 1/Phase 2
Completed NCT02194413 - Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant N/A
Completed NCT01029366 - CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy Phase 1
Terminated NCT03121534 - Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation Phase 2
Withdrawn NCT01620229 - Brentuximab Vedotin After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies Phase 1/Phase 2
Completed NCT01866969 - Quality of Life in Caregivers of Hospitalized Older Patients With Cancer N/A