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

Leukemia Clinical Trial

— Psy-Greffe  

Official title:

Study of the Role of Socio-psychological Factors in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883672
• Other study ID #: AGRAH1
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: September 12, 2020

Study information

• Verified date: April 2024
• Source: Saint-Louis Hospital, Paris, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 12, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Behavioral:
• Personality and transactional factors
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) 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) 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)

Locations

Country	Name	City	State
France	Régis Peffault De Latour	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Five Facets Mindfulness Questionnaire (FFMQ)	Assessement of Mindfulness level as a dispositional dimension. Baert et al., 2006 ; Heeren et al., 2011 39-items scale 5 underscores for each facets of mindful trait: to observe (8 items, max=40), to describe (8 items, max= 40), to act with awareness (8 items, max= 40), to non judge (8 items, max= 40, to non react (7 items, max= 35) Range for full scale: [39-195] More the score is high more the mindfulness level is high. No pathological score	15 days before hospitalization
Primary	General Self Efficacy Scale (GSES)	Assessment of Perceived Self Efficacy level (e.g. Am I think myself able to do something ?) Schwarzer & Jerusalem, 1995 10-items scale. The total score is the sum of all items. Range for full scale : [10-40] More the score is high more the general self efficacy level is high. No pathological score	15 days before hospitalization
Primary	Authentic sustainable happiness scale (ASHS)	Dambrun et al. (2012) Assessment of a happiness component through 13 items (e.g.: satisfaction, general well-being, serenity, etc.). 2 happiness subscales to sum for obtain the total score of hapiness: "contentment" (8 items) and "inner peace" (5 items). Range for full scale: [13-91]. Range for "contentment subscale": [8-56]. range for "inner peace" subscale: [5-35]. More the score is high, more the level of authentic and sustainable happiness is high. No pathological score.; Dambrun et al., 2012 16-items scale	15 days before hospitalization
Primary	Authentic sustainable happiness scale (ASHS)	Dambrun et al. (2012) Assessment of a happiness component through 13 items (e.g.: satisfaction, general well-being, serenity, etc.). 2 happiness subscales to sum for obtain the total score of hapiness: "contentment" (8 items) and "inner peace" (5 items). Range for full scale: [13-91]. Range for "contentment subscale": [8-56]. range for "inner peace" subscale: [5-35]. More the score is high, more the level of authentic and sustainable happiness is high. No pathological score.; Dambrun et al., 2012 16-items scale	6 months after hospitalization
Primary	Life Orientation Test-Revised (LOT-R)	Assessment of dispositional Optimism level Scheier, Carver & Bridge,1994 10-items scale: 6 items assessing optimism component and 4 fillers. The total score is the sum of the 6 items. Range for the total scale: [6-42]. More the score is high, more the optimism level is high. No pathological score.	15 days before hospitalization
Primary	Adult Dispositional Hope Scale (ADHS)	Assessement of Dispositional Hope level of people. Snyder et al., 1991 ; Gana et al., 2012 12-items scale. range for the full scale: [8-64]. 2 subscales: "agency" (4 items, [4-32]), "pathways" (4 items, [4-32]) and 4 fillers. The total score is the sum of the 8 items. More the score is high, more the dispositional hope level is high. No pathological score.	15 days before hospitalization
Primary	Acceptance and Action Questionnaire-version 2 (AAQ-II)	Assessement of two dimensions of psychological flexibility (involved in a good mental health) Bond et al., 2011 ; Monestès et al., 2009 10-items scale. Range for the full scale [10-70]. The total score is the sum of the 10 items. More the the score is high, more the psychological flexibility is high. No pathological score	15 days before hospitalization
Primary	Single Item Self Esteem (SISE)	Assessment of self-esteem dimension Robins et al., 2001; 1-item scale. Range of the item [1-7]. More the score is high, more the self-esteem level is high. No pathological score.	15 days before hospitalization
Primary	Ego Resiliency Scale-revised (EGO-R-r)	Assessment of Resiliency as a dispositional dimension. 2 subscales: "optimal regulation" (6 items, [6-42] and "openness to life experience" (4 items, [4-28]). Range for the full scale: [10-70]. The total score is the sum of the 2 subscales scores (10 items). More the score is high, more the resiliency level is high. No pathological score.; Alessandri, Vecchione, Caprara, & Letzring, 2011 10-items scale	15 days before hospitalization
Primary	Avoidance and Fusion Questionnaire for Adults (AFQ)	Assessement of experiential avoidance and fusion, 2 dimensions of psychological inflexibility (involved in the maintenance of emotional disorders as depression or anxiety) Fergus et al., 2012 17-items scale. Range for the full scale: [0-68]. The total score is the sum of the 17 items. More the score is high, more the psychological inflexibility is high. No pathological score	15 days before hospitalization
Primary	Hospital Anxiety and Depression Scale	Assessement of anxiety and depression symptoms for hospitalized people Zigmond & Snaith, 1983 14-items scale 2 underscores: "depression" score (7 items) and "anxiety" score (7 items). One score for depression is computed (sum of 7 items, [0-21] and one for "anxiety" is computed too (sum of 7 items, [0-21]). For each subscales: a score under 7 is not pathological; between 8 and 10 there is a suspicion of symptomatology; and beyond 11 means an established symptomatology.	15 days before hospitalization
Primary	Hospital Anxiety and Depression Scale	Assessement of anxiety and depression symptoms for hospitalized people Zigmond & Snaith, 1983 14-items scale 2 underscores: "depression" score (7 items) and "anxiety" score (7 items). One score for depression is computed (sum of 7 items, [0-21] and one for "anxiety" is computed too (sum of 7 items, [0-21]). For each subscales: a score under 7 is not pathological; between 8 and 10 there is a suspicion of symptomatology; and beyond 11 means an established symptomatology.	6 months after hospitalization
Primary	Toronto Alexithymia Scale-20 (TAS-20)	Assessment of alexithymia level (i.e. difficulties in experiencing and expressing feelings) Bagby, Parker & Taylor, 2003 ; Loas et al., 1997 20-items scale. Range for the full scale: [20-100]. 3 subscales: "difficulty identifying feelings" (7 items, [7-35]), "difficulty describing feelings to others" (5 items, [5-25]), "externally oriented thinking" (8 items, [8-40]). A score beyond 61 is considered as pathological.	15 days before hospitalization
Primary	Positive Affect and Negative Affect Schedule (PANAS)	Assessment of positive affectivity (curious, motivated, enthusiastic, proud, etc.) and negative affectivity (guilty, nervous, anguished,etc.) levels Watson, Clark & Tellegen, 1988 ; Caci & Baylé, 2007 20-items scale. 2 underscores: positive affectivity score (10 items, [10-50]) and negative affectivity score (10 items, [10-50]). More the score is high for each subscale, more the experience of positive/ negative affectivity is high. No pathological score.	15 days before hospitalization
Primary	Big Five Inventory (BFI)	Assessment of 5 personality dimensions: extraversion (8 items, [8-40], openness (10 items, [10-50]), consciousness (9 items, [9-45]), agreeableness (8 items, [8-40]) and neuroticism (8 items, [8-40]).; John & Srivastava, 1999 ; Plaisant et al., 2010 45-items scale 5 underscores for each personality facet. More the score is high for each personality facet, more the level of extraversion/ openness/ consciousness/ agreeableness/neuroticism is high. No pathological score.	15 days before hospitalization
Primary	Body boundaries scale (BBS)	Assessment of perceived boundaries of body: prominent boundaries or not prominent boundaries are the two extremes of the continuum Dambrun & Ricard, 2012 Analogic scale. range for the full scale [0-15]. More the score is high more the body boundaries are prominent. No pathological score.	15 days before hospitalization
Primary	General Questionnaire SF-12: mental and social quality of life	Mental and social quality of life assessment 12-items scale. For each item one standardized score of mental and social quality of life is computed ( [5,89058 ; 71,96825])and one standardized score is computed for the physical quality of life ([9,94738 ; 70,02246]). the mean among the general population is 50. More the score is high, more the level of quality of life is high.	15 days before hospitalization
Primary	General Questionnaire SF-12: mental and social quality of life	Mental and social quality of life assessment 12-items scale. For each item one standardized score of mental and social quality of life is computed ( [5,89058 ; 71,96825])and one standardized score is computed for the physical quality of life ([9,94738 ; 70,02246]). the mean among the general population is 50. More the score is high, more the level of quality of life is high	6 months after hospitalization
Primary	Social Provisions scale revised	Perceived social support assessment in different settings (attachment, reliable alliance, social integration, reassurance of worth, guidance, ...) Cutrona & Russel, 1987 24-items scale. Range for the full scale [16-96]. 4 items for each subscale (range for each subscales: [4-16]). The total score is the sum of all subscales scores. More the score is high, more the social support is high. No pathological score.	At the 7th day of hospitalization
Primary	Perceived Stress Scale (PSS)	Assessement of perceived stress level (i.e. How much life situations are threatening, unpredictable and uncontrollable).; Cohen, Karmack, Mermelstein, 1983 10-items scale. range for the full scale: [0-40]. The total score is the sum of all the 10 items. Between 0 and 13: low level of perceived stress. Between 14 and 26: middle level of perceived stress. Between 27and 40: high level of perceived stress.	At the 7th day of hospitalization
Primary	Mental Adjustment to Cancer Scale (MACs)	Coping strategies assessment (i.e. What kind of behavioral or emotional strategies are put in place to cope with stressful events). 5 strategies assessed: fighting spirit, avoidance, helplessness-hopelessness, anxious preoccupations, denial.; Watson et al., 1998 ; Cayrou et al., 2003 45-items scale. For each strategy a score is computed: fighting spirit ([13;52], 14 items), avoidance ([5; 20], 5 items), helplessness-hopelessness ([11;44] ,11 items), anxious preoccupations ([12; 48],12 items), denial ([3; 12], 3 items). More the score is high for each subscale, more the fighting spirit / avoidance/ helplessness-hopelessness/ anxious preoccupations/ denial strategy is used. No pathological score	At the 7th day of hospitalization
Primary	Mental Adjustment to Cancer Scale (MACs)	Coping strategies assessment (i.e. What kind of behavioral or emotional strategies are put in place to cope with stressful events). 5 strategies assessed: fighting spirit, avoidance, helplessness-hopelessness, anxious preoccupations, denial.; Watson et al., 1998 ; Cayrou et al., 2003 45-items scale. For each strategy a score is computed: fighting spirit ([13;52], 14 items), avoidance ([5; 20], 5 items), helplessness-hopelessness ([11;44] ,11 items), anxious preoccupations ([12; 48],12 items), denial ([3; 12], 3 items). More the score is high for each subscale, more the fighting spirit / avoidance/ helplessness-hopelessness/ anxious preoccupations/ denial strategy is used. No pathological score	6 months after hospitalization
Primary	Levenson scale - Internality- Power of others and Hasard scale (IPAH scale )	Assessment of 3 locus of control facets : Internality; externality (power of others); externality (chance). This scale aims to determine to whom or what do individuals attribute the reasons for the occurrence of an event.; Jutras, 1987 24-items scale. 3 underscores are computed: internality score (8 items, [6-48]), externality/ power of others (8 items, [6-48]) and externality/ hasard (8 items, [6-48]). More the score for each subscale is high more the internality / externality level is high. No pathological score.	At the 7th day of hospitalization
Primary	Brief Strengths Test	Assessement of personal strengths involved in resiliency, good mental health, happiness. Clustered in 6 different virtues : wisdom and knowledge, courage, humanity, justice, temperance, transcendence.; Park, Peterson & Seligman, 2004 24-items scale. range for the full scale: [24-120]. 6 underscores are computed for each virtue: wisdom and knowledge (5 items, [5-25]), courage (4 items, [4-20]), humanity (3 items, [3-15]), justice (3 items, [3-15]), temperance (4 items, [4-20]), transcendence (5 items, [5-25]). More the score is high, more the level of wisdom and knowledge/ courage/ humanity/ justice/ temperance/ transcendence is high. No pathological score.	At the 7th day of hospitalization
Primary	Brief Strengths Test	Assessement of personal strengths involved in resiliency, good mental health, happiness. Clustered in 6 different virtues : wisdom and knowledge, courage, humanity, justice, temperance, transcendence.; Park, Peterson & Seligman, 2004 24-items scale. range for the full scale: [24-120]. 6 underscores are computed for each virtue: wisdom and knowledge (5 items, [5-25]), courage (4 items, [4-20]), humanity (3 items, [3-15]), justice (3 items, [3-15]), temperance (4 items, [4-20]), transcendence (5 items, [5-25]). More the score is high, more the level of wisdom and knowledge/ courage/ humanity/ justice/ temperance/ transcendence is high. No pathological score.	6 months after hospitalization
Primary	Positive orientation to others scale	Assessment of positive orientation to others level. Braithwaite & Law, 1985 13-items scale. range for the full scale: [13-91]. The total score is the sum of the 13 items. More the score is high, more the orientation to others level is high. No pathological score	At the 7th day of hospitalization
Primary	Positive orientation to others scale	Assessment of positive orientation to others level. Braithwaite & Law, 1985 13-items scale. range for the full scale: [13-91]. The total score is the sum of the 13 items. More the score is high, more the orientation to others level is high. No pathological score	6 months after hospitalization
Primary	Intrinsic spirituality scale	Assessment of spirituality dimension. How much people think spirituality is important for them? Hodge, 2003 6-items scale. Range for the full scale: [0-60]. The total score is the sum of the 6 items. More the score is high, more the intrinsic spirituality level is high. No pathological score	At the 7th day of hospitalization
Primary	Intrinsic spirituality scale	Assessment of spirituality dimension. How much people think spirituality is important for them? Hodge, 2003 6-items scale. Range for the full scale: [0-60]. The total score is the sum of the 6 items. More the score is high, more the intrinsic spirituality level is high. No pathological score	6 months after hospitalization
Primary	Satisfaction with Life Scale	Assessment of cognitive component of happiness. This is a general assessment of people life.; Diener et al.,1985 5-items scale. Range for the full scale: [5-35]. [5-9] : extremely dissatisfied; [10-14]: dissatisfied; [15-19]: slightly dissatisfied; 20: neutral; [21-25]: slightly satisfied; [26-30]: satisfied; [31-35]: extremely satisfied.	At the 7th day of hospitalization
Primary	Satisfaction with Life Scale	Assessment of cognitive component of happiness. This is a general assessment of people life.; Diener et al.,1985 5-items scale. Range for the full scale: [5-35]. [5-9] : extremely dissatisfied; [10-14]: dissatisfied; [15-19]: slightly dissatisfied; 20: neutral; [21-25]: slightly satisfied; [26-30]: satisfied; [31-35]: extremely satisfied.	6 months after hospitalization
Primary	Personal Growth scale	Assessment of one dimension of psychological well-being. Ryff & Essex, 1992 14-items scale. range for the full scale: [14-84]. Total score is the sum of the 14 items. More the score is high, more the level of personal growth is high. No pathological score.	At the 7th day of hospitalization
Primary	Personal Growth scale	Assessment of one dimension of psychological well-being. Ryff & Essex, 1992 14-items scale. range for the full scale: [14-84]. Total score is the sum of the 14 items. More the score is high, more the level of personal growth is high. No pathological score.	6 months after hospitalization
Primary	Post Traumatic Growth Inventory	Assessment of post traumatic growth level which encountered with traumatized people. 5 different dimensions of PTG: changes in relationships , spirituality , personal growth , personal strength, new possibilities, life satisfaction.; Tedeschi & Calhoun, 2004 ; Cadell, Suarez & Hemsworth, 2015 21-items scale. range for the full scale: [0-105]. The total is the sum of the 21 items 5 underscores are computed: changes in relationships (7 items, [0-35]) , spirituality (2 items, [0-10]) , personal strength (4 items, [0-20]), new possibilities (5 items, [0-25]),life satisfaction (3 items, [0-15]). More the score is high, more the level of post traumatic growth is high. No pathological score.	6 months after hospitalization
Primary	Stress version of post traumatic stress disorder scale	Assessment of traumatism level and traumatic symptomatology (e.g. repetition of traumatic event)Weathers et al., 1993 17-items scale. Range for the full scale: [17-85]. The total is the sum of the 17 items. 3 underscores are computed: "repetition of the traumatic event" (5 items, [5-25]), "avoidance" (7 items, [5-35]), "neurovegetative hyperactivity" (5 items, [5-25]). A score beyond 44 is considered as pathological score.	6 months after hospitalization
Primary	Socio-demographic informations: Age	year	15 days before hospitalization
Primary	Socio-demographic informations: sex	2 propositions: man or woman	15 days before hospitalization
Primary	Socio-demographic informations: marital status	5 propositions; single, couple, married, widowed, other	15 days before hospitalization
Primary	Socio-demographic informations: country	people note the country where they were born	15 days before hospitalization
Primary	Socio-demographic informations: educational level	What level of education (i.e. degree)	15 days before hospitalization
Primary	Socio-demographic informations: socioprofessional category	what a job it is	15 days before hospitalization
Primary	Socio-demographic informations: religion	2 propositions: YES or NO	15 days before hospitalization
Primary	complementary informations: weight	they indicate it in kilograms	15 days before hospitalization
Primary	complementary informations: size	they indicate it in meter and centimeters	15 days before hospitalization
Primary	complementary informations: sleeping hours	they indicate it in number of sleeping hours for each night	15 days before hospitalization
Primary	complementary informations: alcohol consumption	2 propositions: YES or NO	15 days before hospitalization
Primary	complementary informations: cigarette consumption	2 propositions: YES or NO	15 days before hospitalization
Primary	complementary informations: physical activity	2 propositions: YES or NO	15 days before hospitalization
Primary	complementary informations: artistic activity	2 propositions: YES or NO	15 days before hospitalization
Primary	complementary informations: dietary regime	2 propositions: YES or NO	15 days before hospitalization
Primary	Physical health informations (PROMISE database)	All these informations are extracted from PROMISE database : type and stage of hemopathy, type of conditioning (myeloablative, non-myeloablative). During follow-up, transplant intake, acute and chronic GvHD, infections, number of days in hospital, relapse and death (and cause)	7 months after hospitalization