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
• Status: Not yet recruiting
• 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
• 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)

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