Etude : ASTERIA /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : ASTERIA

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 22/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C95 - Leucémie à cellules non précisées
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Patients with acute leukemia or received SCT are hospitalized in protected area, at least for 28 days. In this area, there is some rules like: controlled-visit, protective-clothing….so patient are in social and familial isolation condition.
During their hospitalization, patients are confront to aggressive treatment and psychological distress related to potentially death. Emergency hospitalization, illness, controlled environment, aggressive treatment and potential complications place patients in a context of anxiety-provoking. Aesthetic therapy is a new supportive care in cancer therapy access on improving well-being, relaxation and body image. This supportive care is already used in cancerology department, particularly in breast cancer patients. In our department, a few patient received aesthetic care during their hospitalization and they appreciated these sessions and impact on well-being was immediately. Moreover only 6 sessions was proposed and effect on anxiety wasn't measurable Aesthetic care improve well-being but impact on anxiety is unknown. In this study we evaluate the impact of socio aesthetic on the quality of life and anxiety. We evaluate this impact by 3 questionnaires at 3 times during hospitalization.

Study arms:
- Active Comparator: Control
Usual therapy and complete 3 questionnaire at 3 times during hospitalization : Spielberger State-trait Anxiety Inventory + FACT-Leu quality of life and well-being OMS status
Intervention: Other: Questionnaire
- Experimental: Experimental
9 consultations (3 x 3 sessions during hospitalization) of aesthetic care will be provided to patient include in experimental arm and 3 times questionnaires (Spielberger State-trait Anxiety Inventory + FACT-Leu quality of life and well-being OMS status)
Interventions:
Other: Aesthetic therapy sessions
Other: Questionnaire

Current primary outcome:
Anxiety score by Spielberger questionary [ Time Frame: Baseline and Aplasia (between day10 and 14 of hopitalization) ]
Difference between the 2 Arms on anxiety score (Spielberger questionary: composed of 20 items rated from 1 to 4 points)

Current secondary outcome:
- Anxiety score by Spielberger questionary [ Time Frame: Baseline and day 21 of hospitalization ]
Difference between the 2 Arms on anxiety score (Spielberger questionary: composed of 20 items rated from 1 to 4 points)
- Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU). [ Time Frame: Baseline, Aplasia and day 21 of hospitalization ]
Difference betwenn the 2 Arms on quality of life score FACT-LEU questionnary: Leukemia Subscale (LeuS): Range:0-68. To derive: Subtract the answers from "4" for each of the 17 questions, Range: 0-176.
- Well-being score [ Time Frame: Baseline, Aplasia and day 21 of hospitalization ]
Difference between the 2 Arms on well-being score (OMS questionary)

Phase : NA

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patient (male or female) ≥18 years old
- Hospitalized patient in restricted area than 21 days
- Patient with acute leukemia (induction or relapse)
- Patient hospitalized for hematopoietic stem cell transplantation
- Written Inform consent must be obtained before inclusion and randomization
- Patient affiliated to and covered by social security for standard care

Critères de non-inclusion : - Patient hospitalized for another disease
- Inability to receive study information and/or understand/speak French
- Inability to give informed consent
- Legal incapacity (people in jail) or under supervision (i.e. guardianship or curatorship)
- Already include in this study on a previous hospitalization
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03959007
Promoteur :
CHU de Lille
Type de sponsor : Institutionnel
59000 LILLE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Madame Florence PERRAUDIN (Cadre de Santé)

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : OUVERT

MAJ : 22/10/2019