LeukemiaPsy-GreffeNCT03883672
Socio-psychological Factors Involved in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies
A study testing Personality and transactional factors in people with Leukemia, run by Saint-Louis Hospital, Paris, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Personality and transactional factors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2017to 12 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 )
Who cannot join
- patients receiving autograft
- patient under 18 years of age
- patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Role of Socio-psychological Factors in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies
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).
Read the detailed description
To reach the research purposes, questionnaires will be given to patients at different times during the transplant process :
- 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)
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
- Being tested
- Personality and transactional factors
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personality and transactional factorsBehavioural
- 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)
| Study group | Role | What they receive |
|---|---|---|
| hematopoietic stem cell transplantation | Experimental | Personality and transactional factors involved in the process and outcomes of hematopoietic stem cell transplantation Receives: Behavioral: Personality and transactional factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after hospitalization
Socio-demographic informations: Age
year
Measured: 15 days before hospitalization
Socio-demographic informations: sex
2 propositions: man or woman
Measured: 15 days before hospitalization
Socio-demographic informations: marital status
5 propositions; single, couple, married, widowed, other
Measured: 15 days before hospitalization
Socio-demographic informations: country
people note the country where they were born
Measured: 15 days before hospitalization
Socio-demographic informations: educational level
What level of education (i.e. degree)
Measured: 15 days before hospitalization
Socio-demographic informations: socioprofessional category
what a job it is
Measured: 15 days before hospitalization
Socio-demographic informations: religion
2 propositions: YES or NO
Measured: 15 days before hospitalization
complementary informations: weight
they indicate it in kilograms
Measured: 15 days before hospitalization
complementary informations: size
they indicate it in meter and centimeters
Measured: 15 days before hospitalization
complementary informations: sleeping hours
they indicate it in number of sleeping hours for each night
Measured: 15 days before hospitalization
complementary informations: alcohol consumption
2 propositions: YES or NO
Measured: 15 days before hospitalization
complementary informations: cigarette consumption
2 propositions: YES or NO
Measured: 15 days before hospitalization
complementary informations: physical activity
2 propositions: YES or NO
Measured: 15 days before hospitalization
complementary informations: artistic activity
2 propositions: YES or NO
Measured: 15 days before hospitalization
complementary informations: dietary regime
2 propositions: YES or NO
Measured: 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)
Measured: 7 months after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start10 Nov 2017
- Primary completion20 Feb 2020
- Study completion12 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Louis Hospital, Paris, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Régis Peffault de Latour, Saint-Louis Hospital, Paris, France
- Investigators
- Régis Peffault De Latour, Pr., Principal investigator, Saint-Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883672
- Sponsor's protocol ID
- AGRAH1
- Acronym
- Psy-Greffe
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2018
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33430807
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Socio-psychological Factors in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies
- ClinicalTrials.gov ID
- NCT03883672
- Acronym / sponsor ID
- Psy-Greffe / AGRAH1
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Saint-Louis Hospital, Paris, FranceUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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)
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hematopoietic stem cell transplantation | Experimental | Behavioral: Personality and transactional factorsPersonality and transactional factors involved in the process and outcomes of hematopoietic stem cell transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 )
Key exclusion criteria (3 listed)
- patients receiving autograft
- patient under 18 years of age
- patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personality and transactional factors1. 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) | Behavioural | hematopoietic stem cell transplantation |
Primary outcome
Five Facets Mindfulness Questionnaire (FFMQ)
Time frame: 15 days before hospitalization
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
General Self Efficacy Scale (GSES)
Time frame: 15 days before hospitalization
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
Authentic sustainable happiness scale (ASHS)
Time frame: 15 days before hospitalization
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
Authentic sustainable happiness scale (ASHS)
Time frame: 6 months after hospitalization
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
Life Orientation Test-Revised (LOT-R)
Time frame: 15 days before hospitalization
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.
Adult Dispositional Hope Scale (ADHS)
Time frame: 15 days before hospitalization
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.
Acceptance and Action Questionnaire-version 2 (AAQ-II)
Time frame: 15 days before hospitalization
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
Single Item Self Esteem (SISE)
Time frame: 15 days before hospitalization
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.
Ego Resiliency Scale-revised (EGO-R-r)
Time frame: 15 days before hospitalization
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
Avoidance and Fusion Questionnaire for Adults (AFQ)
Time frame: 15 days before hospitalization
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
Hospital Anxiety and Depression Scale
Time frame: 15 days before hospitalization
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.
Hospital Anxiety and Depression Scale
Time frame: 6 months after hospitalization
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.
Toronto Alexithymia Scale-20 (TAS-20)
Time frame: 15 days before hospitalization
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.
Positive Affect and Negative Affect Schedule (PANAS)
Time frame: 15 days before hospitalization
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.
Big Five Inventory (BFI)
Time frame: 15 days before hospitalization
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.
Body boundaries scale (BBS)
Time frame: 15 days before hospitalization
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.
General Questionnaire SF-12: mental and social quality of life
Time frame: 15 days before hospitalization
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.
General Questionnaire SF-12: mental and social quality of life
Time frame: 6 months after hospitalization
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
Social Provisions scale revised
Time frame: At the 7th day of hospitalization
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.
Perceived Stress Scale (PSS)
Time frame: At the 7th day of hospitalization
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.
Mental Adjustment to Cancer Scale (MACs)
Time frame: At the 7th day of hospitalization
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
Mental Adjustment to Cancer Scale (MACs)
Time frame: 6 months after hospitalization
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
Levenson scale - Internality- Power of others and Hasard scale (IPAH scale )
Time frame: At the 7th day of hospitalization
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.
Brief Strengths Test
Time frame: At the 7th day of hospitalization
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.
Brief Strengths Test
Time frame: 6 months after hospitalization
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.
Positive orientation to others scale
Time frame: At the 7th day of hospitalization
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
Positive orientation to others scale
Time frame: 6 months after hospitalization
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
Intrinsic spirituality scale
Time frame: At the 7th day of hospitalization
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
Intrinsic spirituality scale
Time frame: 6 months after hospitalization
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
Satisfaction with Life Scale
Time frame: At the 7th day of hospitalization
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.
Satisfaction with Life Scale
Time frame: 6 months after hospitalization
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.
Personal Growth scale
Time frame: At the 7th day of hospitalization
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.
Personal Growth scale
Time frame: 6 months after hospitalization
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.
Post Traumatic Growth Inventory
Time frame: 6 months after hospitalization
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.
Stress version of post traumatic stress disorder scale
Time frame: 6 months after hospitalization
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.
Socio-demographic informations: Age
Time frame: 15 days before hospitalization
year
Socio-demographic informations: sex
Time frame: 15 days before hospitalization
2 propositions: man or woman
Socio-demographic informations: marital status
Time frame: 15 days before hospitalization
5 propositions; single, couple, married, widowed, other
Socio-demographic informations: country
Time frame: 15 days before hospitalization
people note the country where they were born
Socio-demographic informations: educational level
Time frame: 15 days before hospitalization
What level of education (i.e. degree)
Socio-demographic informations: socioprofessional category
Time frame: 15 days before hospitalization
what a job it is
Socio-demographic informations: religion
Time frame: 15 days before hospitalization
2 propositions: YES or NO
complementary informations: weight
Time frame: 15 days before hospitalization
they indicate it in kilograms
complementary informations: size
Time frame: 15 days before hospitalization
they indicate it in meter and centimeters
complementary informations: sleeping hours
Time frame: 15 days before hospitalization
they indicate it in number of sleeping hours for each night
complementary informations: alcohol consumption
Time frame: 15 days before hospitalization
2 propositions: YES or NO
complementary informations: cigarette consumption
Time frame: 15 days before hospitalization
2 propositions: YES or NO
complementary informations: physical activity
Time frame: 15 days before hospitalization
2 propositions: YES or NO
complementary informations: artistic activity
Time frame: 15 days before hospitalization
2 propositions: YES or NO
complementary informations: dietary regime
Time frame: 15 days before hospitalization
2 propositions: YES or NO
Physical health informations (PROMISE database)
Time frame: 7 months after hospitalization
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 33430807Corman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Régis Peffault De Latour, Pr. principal investigator
Saint-Louis Hospital, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personality and transactional factors in people with Leukemia, run by Saint-Louis Hospital, Paris, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five Facets Mindfulness Questionnaire (FFMQ) (time frame: 15 days before hospitalization). The study lists 51 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.