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Not yet recruiting NCT05327673

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

Observational Allogeneic Hematopoietic Stem Cell Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: questionnaire.
Who it may be relevant to
Registry conditions: Allogeneic Hematopoietic Stem Cell Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

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

Primary outcome measures

  • Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire) [Time frame: 24 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de la Réunion — Saint-Pierre

Identifiers

NCT: NCT05327673 · 2020/CHU/21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗