Leukemia Clinical Trial
— Psy-GreffeOfficial title:
Study of the Role of Socio-psychological Factors in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies
Verified date | April 2024 |
Source | Saint-Louis Hospital, Paris, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
France | Régis Peffault De Latour | Paris |
Lead Sponsor | Collaborator |
---|---|
Saint-Louis Hospital, Paris, France |
France,
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 |
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