Allogeneic Hematopoietic Stem Cell TransplantationAlloRéNCT05327673
Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
This project aims to document and analyse - with a three-fold anthropological, psychosocial and economical approach - the consequences of the geographical distance from mainland France on the alloSCT on both patients, their caregivers and the healthcare system. It is organised in 3 working packages (WP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- questionnaire
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with myeloid acute leukemia, lymphoid acute leukemia, non-hodgkin lymphoma, Hodgkin disease, or myelodysplasic syndrome candidate to an allogeneic hematopoietic stem cell transplantation in mainland
Who may be able to join
- patients diagnosed with hematological malignancy (myeloid acute leukemia, lymphoid acute leukemia, non-hodgkin lymphoma, Hodgkin disease, or myelodysplasic syndrome
- candidate to an allogeneic hematopoietic stem cell transplantation in mainland France ;
- Residing in Reunion Island
- Age >18 year old;
- who accept or not allogeneic hematopoietic
- Able to complete a questionnaire
Who cannot join
- Opposition to participation and collection of their data
- Person deprived of liberty by judicial or administrative decision, and person subject to legal protection (guardianship or curators)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de la Réunion
Saint-Pierre, 97448
Lucie AUZANNEAU, lucie.auzanneau@chu-reunion.fr
Patricia ZUNIC, PH
About this study
This project aims to document and analyse - with a three-fold anthropological, psychosocial and economical approach - the consequences of the geographical distance from mainland France on the alloSCT on both patients, their caregivers and the healthcare system. It is organised in 3 working packages (WP).
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
- quality of life score: FACT-BMT
- decisional conflict scale
- Discreet Choice Experiment questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patients who accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT) | Not described Receives: Other: questionnaire | |
| patients who did not accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT) | Not described Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire)
Measured: 24 months
Secondary outcomes (5)
satisfaction with decision questionnaire
Measured: 24 months
decision regret scale
Measured: 24 months
fear of recurrence questionnaire
Measured: 24 months
preferences of patients questionnaire
Measured: 24 months
cost of treatment
impact on patients and caregivers; impact on society
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study startJul 2022 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Paoli-Calmettes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327673
- Sponsor's protocol ID
- 2020/CHU/21
- Acronym
- AlloRé
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions
- ClinicalTrials.gov ID
- NCT05327673
- Acronym / sponsor ID
- AlloRé / 2020/CHU/21
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Institut Paoli-Calmettes
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Apr 2022 (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.
This project aims to document and analyse - with a three-fold anthropological, psychosocial and economical approach - the consequences of the geographical distance from mainland France on the alloSCT on both patients, their caregivers and the healthcare system. It is organised in 3 working packages (WP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT) | – | Other: questionnaire |
| patients who did not accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT) | – | Other: questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with myeloid acute leukemia, lymphoid acute leukemia, non-hodgkin lymphoma, Hodgkin disease, or myelodysplasic syndrome candidate to an allogeneic hematopoietic stem cell transplantation in mainland
Key inclusion criteria (6 listed)
- patients diagnosed with hematological malignancy (myeloid acute leukemia, lymphoid acute leukemia, non-hodgkin lymphoma, Hodgkin disease, or myelodysplasic syndrome
- candidate to an allogeneic hematopoietic stem cell transplantation in mainland France ;
- Residing in Reunion Island
- Age >18 year old;
- who accept or not allogeneic hematopoietic
Key exclusion criteria (2 listed)
- Opposition to participation and collection of their data
- Person deprived of liberty by judicial or administrative decision, and person subject to legal protection (guardianship or curators)
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* quality of life score: FACT-BMT * decisional conflict scale * Discreet Choice Experiment questionnaire | Other | patients who accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT), patients who did not accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT) |
Primary outcome
Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire)
Time frame: 24 months
5 secondary outcomes
satisfaction with decision questionnaire
Time frame: 24 months
decision regret scale
Time frame: 24 months
fear of recurrence questionnaire
Time frame: 24 months
preferences of patients questionnaire
Time frame: 24 months
cost of treatment
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation, run by Centre Hospitalier Universitaire de la Réunion 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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Apr 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU (0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire) (time frame: 24 months). 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 21 Apr 2022.