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

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05327673
Collaborator
Institut Paoli-Calmettes (Other)
100
Enrollment
1
Location
56
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire) [24 months]

Secondary Outcome Measures

  1. satisfaction with decision questionnaire [24 months]

  2. decision regret scale [24 months]

  3. fear of recurrence questionnaire [24 months]

  4. preferences of patients questionnaire [24 months]

  5. cost of treatment [24 months]

    impact on patients and caregivers; impact on society

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de la Réunion Saint-Pierre France 97448

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion
  • Institut Paoli-Calmettes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT05327673
Other Study ID Numbers:
  • 2020/CHU/21
First Posted:
Apr 14, 2022
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 21, 2022