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NCT05327673 Clinical Trial

Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

— AlloRé  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05327673
Other study ID # 2020/CHU/21
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2022
Est. completion date March 2027

Study information
Verified date April 2022
Source Centre Hospitalier Universitaire de la Réunion
Contact Lucie AUZANNEAU
Phone 0262359949
Email lucie.auzanneau@chu-reunion.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 2027
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Study Design

Related Conditions & MeSH terms

  • Allogeneic Hematopoietic Stem Cell Transplantation

Intervention

Other:
• questionnaire
quality of life score: FACT-BMT decisional conflict scale Discreet Choice Experiment questionnaire

Locations
Country Name City State
France CHU de la Réunion Saint-Pierre

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire) 24 months
Secondary satisfaction with decision questionnaire 24 months
Secondary decision regret scale 24 months
Secondary fear of recurrence questionnaire 24 months
Secondary preferences of patients questionnaire 24 months
Secondary cost of treatment impact on patients and caregivers; impact on society 24 months
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