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NCT Number: NCT05327673

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de la Réunion

Saint-Pierre, 97448, France

Location contact

Lucie AUZANNEAU

CONTACT

[email protected]

Patricia ZUNIC, PH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

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

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

  1. satisfaction with decision questionnaire

    Time frame: 24 months

  2. decision regret scale

    Time frame: 24 months

  3. fear of recurrence questionnaire

    Time frame: 24 months

  4. preferences of patients questionnaire

    Time frame: 24 months

  5. cost of treatment

    Time frame: 24 months

    impact on patients and caregivers; impact on society

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie AUZANNEAU

CONTACT

[email protected]

0262359949 ext. +262

Patricia MARINO

CONTACT

[email protected]

04.91.22.35.02 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Collaborators

  • Institut Paoli-Calmettes

Registry information

Acronym: AlloRé

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2022
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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