Hematopoietic/Lymphoid Cancer Clinical Trial
Official title:
Hematopoietic Stem Cell Transplantation and Childhood Leukemia: Quality of Life in SIbling DONors, Years After the Donation
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 ...).
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 ...).
;
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 |