An interventional study of Personality and transactional factors in Leukemia, sponsored by Saint-Louis Hospital, Paris, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Saint-Louis Hospital, Paris, France · Not applicable, Interventional, and Other
Among 172 studies in Leukemia with a site in France — 30 open to participants now, 41 under way, 9 of them phase 3. Leukemia · France.
Among the 172 studies in Leukemia with a site in France, this one is the 43rd largest by enrollment of the 150 interventional ones that give a count, is one of 6 that started in 2017, is one of 22 with no phase, and was the 120th registered.
2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.
Browse Leukemia studies →30 of the 172 studies in Leukemia with a site in France are open now. Recruiting first, the newest first:
University Hospital, Strasbourg, France · Sites in France
Ages 0–17
Quetzal Therapeutics · Sites in France, United States, Italy and 2 more countries
Ages 18–71
Gustave Roussy, Cancer Campus, Grand Paris · Sites in France
Ages 18+
Novartis Pharmaceuticals · Sites in France, United States, Australia and 14 more countries
Ages 1–18
Princess Maxima Center for Pediatric Oncology · Sites in France, Austria, Belgium and 11 more countries
Ages 1–21
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 208 Leukemia studies recruiting now, 112 (54%) set no upper age limit and 74 (36%) stop at 75 or younger; 86 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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172 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 45 · Phase 2 62 · Phase 3 46 · Phase 4 4
First in 1993; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 280 is above the median of 40 across 1,769 interventional studies indexed under Leukemia.
Median enrollment 129 across the 150 interventional studies, 350 across the 19 observational. Of the 107 that completed or were terminated, 56 (52%) have results posted.
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90 of 172 have an industry lead sponsor. The 10 most frequent:
Saint-Louis Hospital, Paris, France is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Saint-Louis Hospital, Paris, France has 1 study filed under Leukemia — fewer than ten, so there is no comparison to draw.
8 of the studies in Leukemia with a site in France that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07504458Phase 3Quetzal TherapeuticsPivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia | 2027-03 |
| NCT03836261Phase 3Acerta Pharma BVStudy of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL | 2027-04-30 |
| NCT04256317Phase 3Taiho Oncology, Inc.A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | 2027-11-01 |
| NCT05475925Dren BioA Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas | 2026-12 |
| NCT07898436University Hospital, Strasbourg, FranceMenin Inhibitors in Pediatric Relapsed or Refractory Acute Leukemia | 2027-01-08 |
Add all 8 to your calendar (.ics) → With an account.
Among the 172 studies in Leukemia with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
To reach the research purposes, questionnaires will be given to patients at different times during the transplant process :
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Personality and transactional factors involved in the process and outcomes of hematopoietic stem cell transplantation
Behavioral: 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)
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
Time frame: 15 days before hospitalization
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
Time frame: 15 days before hospitalization
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
Time frame: 15 days before hospitalization
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
Time frame: 6 months after hospitalization
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.
Time frame: 15 days before hospitalization
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.
Time frame: 15 days before hospitalization
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
Time frame: 15 days before hospitalization
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.
Time frame: 15 days before hospitalization
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
Time frame: 15 days before hospitalization
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
Time frame: 15 days before hospitalization
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.
Time frame: 15 days before hospitalization
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.
Time frame: 6 months after hospitalization
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.
Time frame: 15 days before hospitalization
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.
Time frame: 15 days before hospitalization
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.
Time frame: 15 days before hospitalization
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.
Time frame: 15 days before hospitalization
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.
Time frame: 15 days before hospitalization
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
Time frame: 6 months after hospitalization
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.
Time frame: At the 7th day of hospitalization
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.
Time frame: At the 7th day of hospitalization
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
Time frame: At the 7th day of hospitalization
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
Time frame: 6 months after hospitalization
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.
Time frame: At the 7th day of hospitalization
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.
Time frame: At the 7th day of hospitalization
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.
Time frame: 6 months after hospitalization
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
Time frame: At the 7th day of hospitalization
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
Time frame: 6 months after hospitalization
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
Time frame: At the 7th day of hospitalization
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
Time frame: 6 months after hospitalization
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.
Time frame: At the 7th day of hospitalization
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.
Time frame: 6 months after hospitalization
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.
Time frame: At the 7th day of hospitalization
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.
Time frame: 6 months after hospitalization
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.
Time frame: 6 months after hospitalization
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.
Time frame: 6 months after hospitalization
Socio-demographic informations: Age
year
Time frame: 15 days before hospitalization
Socio-demographic informations: sex
2 propositions: man or woman
Time frame: 15 days before hospitalization
Socio-demographic informations: marital status
5 propositions; single, couple, married, widowed, other
Time frame: 15 days before hospitalization
Socio-demographic informations: country
people note the country where they were born
Time frame: 15 days before hospitalization
Socio-demographic informations: educational level
What level of education (i.e. degree)
Time frame: 15 days before hospitalization
Socio-demographic informations: socioprofessional category
what a job it is
Time frame: 15 days before hospitalization
Socio-demographic informations: religion
2 propositions: YES or NO
Time frame: 15 days before hospitalization
complementary informations: weight
they indicate it in kilograms
Time frame: 15 days before hospitalization
complementary informations: size
they indicate it in meter and centimeters
Time frame: 15 days before hospitalization
complementary informations: sleeping hours
they indicate it in number of sleeping hours for each night
Time frame: 15 days before hospitalization
complementary informations: alcohol consumption
2 propositions: YES or NO
Time frame: 15 days before hospitalization
complementary informations: cigarette consumption
2 propositions: YES or NO
Time frame: 15 days before hospitalization
complementary informations: physical activity
2 propositions: YES or NO
Time frame: 15 days before hospitalization
complementary informations: artistic activity
2 propositions: YES or NO
Time frame: 15 days before hospitalization
complementary informations: dietary regime
2 propositions: YES or NO
Time frame: 15 days before hospitalization
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)
Time frame: 7 months after hospitalization
Plan to share: No
Ran from Nov 2017 to primary completion in Feb 2020, 27 months.
Of 103 non-industry interventional studies with no phase under Leukemia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 128. This study's 27 months is below that.
Counting every sponsor, half of 110 studies reached it within 38 months; a quarter within 22 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Saint-Louis Hospital, Paris, France