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

April 14, 2022 updated by: Centre Hospitalier Universitaire de la Réunion
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients who accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT)
Other: questionnaire
  • quality of life score: FACT-BMT
  • decisional conflict scale
  • Discreet Choice Experiment questionnaire
patients who did not accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT)
Other: questionnaire
  • quality of life score: FACT-BMT
  • decisional conflict scale
  • Discreet Choice Experiment questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction with decision questionnaire
Time Frame: 24 months
24 months
decision regret scale
Time Frame: 24 months
24 months
fear of recurrence questionnaire
Time Frame: 24 months
24 months
preferences of patients questionnaire
Time Frame: 24 months
24 months
cost of treatment
Time Frame: 24 months
impact on patients and caregivers; impact on society
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Collaborators

Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

January 1, 2027

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2020/CHU/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trials on questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe