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

NCT05327673 | Not Yet Recruiting

• 1 other identifier: 2020/CHU/21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire)

  24 months

Secondary Outcomes (5)

• satisfaction with decision questionnaire

  24 months

• decision regret scale

  24 months

• fear of recurrence questionnaire

  24 months

• preferences of patients questionnaire

  24 months

• cost of treatment

  24 months

Study Arms (2)

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

Interventions

questionnaire OTHER

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

patients who accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT); patients who did not accept Allogeneic Hematopoietic Stem Cell Transplantation (alloH SCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead
• Institut Paoli-Calmettes: collaborator

Study Sites (1)

CHU de la Réunion

Saint-Pierre, 97448, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lucie AUZANNEAU

CONTACT

0262359949; lucie.auzanneau@chu-reunion.fr

Patricia MARINO

CONTACT

04.91.22.35.02; patricia.marino@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)