Clinical trial NCT03883672: Socio-psychological Factors Involved in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies
Official title: Study of the Role of Socio-psychological Factors in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Lead sponsor: Saint-Louis Hospital, Paris, France
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Five Facets Mindfulness Questionnaire (FFMQ)
timeFrame: 15 days before hospitalization
measure: General Self Efficacy Scale (GSES)
timeFrame: 15 days before hospitalization
measure: Authentic sustainable happiness scale (ASHS)
timeFrame: 15 days before hospitalization
measure: Authentic sustainable happiness scale (ASHS)
timeFrame: 6 months after hospitalization
measure: Life Orientation Test-Revised (LOT-R)
timeFrame: 15 days before hospitalization
measure: Adult Dispositional Hope Scale (ADHS)
timeFrame: 15 days before hospitalization
measure: Acceptance and Action Questionnaire-version 2 (AAQ-II)
timeFrame: 15 days before hospitalization
measure: Single Item Self Esteem (SISE)
timeFrame: 15 days before hospitalization
measure: Ego Resiliency Scale-revised (EGO-R-r)
timeFrame: 15 days before hospitalization
measure: Avoidance and Fusion Questionnaire for Adults (AFQ)
timeFrame: 15 days before hospitalization
measure: Hospital Anxiety and Depression Scale
timeFrame: 15 days before hospitalization
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 months after hospitalization
measure: Toronto Alexithymia Scale-20 (TAS-20)
timeFrame: 15 days before hospitalization
measure: Positive Affect and Negative Affect Schedule (PANAS)
timeFrame: 15 days before hospitalization
measure: Big Five Inventory (BFI)
timeFrame: 15 days before hospitalization
measure: Body boundaries scale (BBS)
timeFrame: 15 days before hospitalization
measure: General Questionnaire SF-12: mental and social quality of life
timeFrame: 15 days before hospitalization
measure: General Questionnaire SF-12: mental and social quality of life
timeFrame: 6 months after hospitalization
measure: Social Provisions scale revised
timeFrame: At the 7th day of hospitalization
measure: Perceived Stress Scale (PSS)
timeFrame: At the 7th day of hospitalization
measure: Mental Adjustment to Cancer Scale (MACs)
timeFrame: At the 7th day of hospitalization
measure: Mental Adjustment to Cancer Scale (MACs)
timeFrame: 6 months after hospitalization
measure: Levenson scale - Internality- Power of others and Hasard scale (IPAH scale )
timeFrame: At the 7th day of hospitalization
measure: Brief Strengths Test
timeFrame: At the 7th day of hospitalization
measure: Brief Strengths Test
timeFrame: 6 months after hospitalization
measure: Positive orientation to others scale
timeFrame: At the 7th day of hospitalization
measure: Positive orientation to others scale
timeFrame: 6 months after hospitalization
measure: Intrinsic spirituality scale
timeFrame: At the 7th day of hospitalization
measure: Intrinsic spirituality scale
timeFrame: 6 months after hospitalization
measure: Satisfaction with Life Scale
timeFrame: At the 7th day of hospitalization
measure: Satisfaction with Life Scale
timeFrame: 6 months after hospitalization
measure: Personal Growth scale
timeFrame: At the 7th day of hospitalization
measure: Personal Growth scale
timeFrame: 6 months after hospitalization
measure: Post Traumatic Growth Inventory
timeFrame: 6 months after hospitalization
measure: Stress version of post traumatic stress disorder scale
timeFrame: 6 months after hospitalization
measure: Socio-demographic informations: Age
timeFrame: 15 days before hospitalization
measure: Socio-demographic informations: sex
timeFrame: 15 days before hospitalization
measure: Socio-demographic informations: marital status
timeFrame: 15 days before hospitalization
measure: Socio-demographic informations: country
timeFrame: 15 days before hospitalization
measure: Socio-demographic informations: educational level
timeFrame: 15 days before hospitalization
measure: Socio-demographic informations: socioprofessional category
timeFrame: 15 days before hospitalization
measure: Socio-demographic informations: religion
timeFrame: 15 days before hospitalization
measure: complementary informations: weight
timeFrame: 15 days before hospitalization
measure: complementary informations: size
timeFrame: 15 days before hospitalization
measure: complementary informations: sleeping hours
timeFrame: 15 days before hospitalization
measure: complementary informations: alcohol consumption
timeFrame: 15 days before hospitalization
measure: complementary informations: cigarette consumption
timeFrame: 15 days before hospitalization
measure: complementary informations: physical activity
timeFrame: 15 days before hospitalization
measure: complementary informations: artistic activity
timeFrame: 15 days before hospitalization
measure: complementary informations: dietary regime
timeFrame: 15 days before hospitalization
measure: Physical health informations (PROMISE database)
timeFrame: 7 months after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Régis Peffault De Latour
Study officials:
affiliation: Saint-Louis Hospital, Paris, France
name: Régis Peffault De Latour, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.