Socio-psychological Factors Involved in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies

NCT ID: NCT03883672

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2020-09-12

Brief Summary

Identify the psychological factors (i.e. personality and transactional factors), beneficial and deleterious, at different phases of the transplant process, on the patient's mental health (quality of life, short and long-term post-transplant recovery) and physical health (e.g. infections, relapse, length of hospitalization or even death).

Detailed Description

To reach the research purposes, questionnaires will be given to patients at different times during the transplant process :

1. Pre-admission transplant questionnaire: given and collected by the transplant physician during the pre-graft consultation before entering hospitalization (approximatively 15 days before). To be completed by the patient on site (approximately 45 minutes to complete the questionnaire)

2. Transplant admission questionnaire: given during the first days of hospitalization. To be completed within 6 days and returned to the transplant physician (approximately 30 minutes to complete the questionnaire)

3. Post-transplant follow-up questionnaire: given in consultation at 6 months by the transplant physician (between 30 and 45 minutes to complete the questionnaire in consultation)

The questionnaires include validated and standardized scales.

The first questionnaire contains scales on dispositional factors (i.e. personality factors) . The second one is on the so-called transactional adjustment factors. And the third is on post-transplant factors (e. g. post-traumatic growth). Scales from the first and second questionnaire will be used to obtain a longitudinal view.

The study population concerns all patients going to receive an allograft transplantation, aged over 18 years, who have consented to answer the various questionnaires over a period of approximately 7 months . The participants come from the hematology departments of the Saint-Louis Hospital in Paris, the Estaing University Hospital in Clermont-Ferrand and the Brabois Hospital in Nancy.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

hematopoietic stem cell transplantation

Personality and transactional factors involved in the process and outcomes of hematopoietic stem cell transplantation

Group Type: EXPERIMENTAL

Personality and transactional factors

Intervention Type: BEHAVIORAL

1. Pre-admission transplant questionnaire: given and collected by the transplant physician during the pre-graft consultation before entering hospitalization (approximatively 15 days before). To be completed by the patient on site (approximately 45 minutes to complete the questionnaire)

2. Transplant admission questionnaire: given during the first days of hospitalization. To be completed within 6 days and returned to the transplant physician (approximately 30 minutes to complete the questionnaire)

3. Post-transplant follow-up questionnaire: given in consultation at 6 months by the transplant physician (between 30 and 45 minutes to complete the questionnaire in consultation)

Interventions

Personality and transactional factors

1. Pre-admission transplant questionnaire: given and collected by the transplant physician during the pre-graft consultation before entering hospitalization (approximatively 15 days before). To be completed by the patient on site (approximately 45 minutes to complete the questionnaire)

2. Transplant admission questionnaire: given during the first days of hospitalization. To be completed within 6 days and returned to the transplant physician (approximately 30 minutes to complete the questionnaire)

3. Post-transplant follow-up questionnaire: given in consultation at 6 months by the transplant physician (between 30 and 45 minutes to complete the questionnaire in consultation)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patient with hematopathy with allograft HSC indication
• allograft protocol
• patient over 18 years of age
• patient who has read and understood the information note and who has consented has not objected to participating in the research
• patient affiliated to a social security system (beneficiary )

Exclusion Criteria

• patients receiving autograft
• patient under 18 years of age
• patient under guardianship or curatorship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role: lead

Responsible Party

Régis Peffault de Latour

Professor Regis Peffault De Latour

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Régis Peffault De Latour, Pr.

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Locations

Régis Peffault De Latour

Paris, , France

Countries

France

References

Corman M, Rubio MT, Cabrespine A, Brindel I, Bay JO, De La Tour RP, Dambrun M. Retrospective and prospective measures of post-traumatic growth reflect different processes: longitudinal evidence of greater decline than growth following a hematopoietic stem-cell transplantation. BMC Psychiatry. 2021 Jan 11;21(1):27. doi: 10.1186/s12888-020-03007-y.

Reference Type: DERIVED

PMID: 33430807 (View on PubMed)

Other Identifiers

AGRAH1

Identifier Type: -

Identifier Source: org_study_id