Hematopoietic/Lymphoid CancerSIDONYNCT03659071
Hematopoietic Stem Cell Transplantation and Childhood Leukemia Quality of Life in SIbling DONors
A study testing questionnaire VSP-A in people with Hematopoietic/Lymphoid Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Hematopoietic/Lymphoid Cancer
- What is being tested?
- questionnaire VSP-A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,187 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2018to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- experimental group familly:
- child included in the LEA cohort
- having received allogeneic treatment of geno-identical sibling haematopoietic stem cells
- Criteria for the inclusion of siblings (experimental group)
- be the brother (or sister) donor of hematopoietic stem cells
- currently at least 8 years old
Show all 17Show fewer
- 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
- Criteria for the inclusion of siblings (control group)
- 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.
Who cannot join
- not to be allowed to participate in the study by his parents or legal representatives
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
About this study
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.
Read more
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 ...).
Read the detailed 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 ...).
- Conditions
- Hematopoietic/Lymphoid Cancer
- Being tested
- questionnaire VSP-A
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire VSP-AOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: questionnaire VSP-A |
| NON DONORS | Other | non-donor siblings. questionnaire VSP-A will be performed Receives: Other: questionnaire VSP-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic/Lymphoid CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659071
- Sponsor's protocol ID
- RCAPHM17_0169
- Acronym
- SIDONY
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Stem Cell Transplantation and Childhood Leukemia: Quality of Life in SIbling DONors, Years After the Donation
- ClinicalTrials.gov ID
- NCT03659071
- Acronym / sponsor ID
- SIDONY / RCAPHM17_0169
- Conditions
- Hematopoietic/Lymphoid Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,187 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ...).
Detailed 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DONORS | Experimental | Other: questionnaire VSP-Adonors from the siblings of survivors of acute childhood leukemia who have received hematopoietic stem cell transplantation questionnaire VSP-A will be performed |
| NON DONORS | Other | Other: questionnaire VSP-Anon-donor siblings. questionnaire VSP-A will be performed |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- experimental group familly:
- Criteria for the inclusion of siblings (experimental group)
- Control group familly
- Criteria for the inclusion of siblings (control group)
Key exclusion criteria (1 listed)
- not to be allowed to participate in the study by his parents or legal representatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire VSP-AVSP-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) | Other | DONORS, NON DONORS |
Primary outcome
Quality of life scores
Time frame: 1 day
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire VSP-A in people with Hematopoietic/Lymphoid Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JULIE BERBIS, MD (+33 491366.025, Julie.BERBIS@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life scores (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.