Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases

Study Overview
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Brief Summary
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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 off socio aesthetic on the quality off life and anxiety. We evaluate this impact by 3 questionnaires at 3 times during hospitalization.

Official Title
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Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases

Conditions
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Acute Leukemia, Hematopoietic Stem Cell Transplantation (SCT), Aplasia

Intervention / Treatment
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* Other: Aesthetic therapy sessions
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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 | Other: Questionnaire<br>* Both arm at 3 times during hospitalization<br>|
| Experimental: Experimental<br>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) | Other: Aesthetic therapy sessions<br>* Only for experimental arm at 3 times during hospitalization<br>Other: Questionnaire<br>* Both arm at 3 times during hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score by Spielberger questionary | Difference between the 2 Arms on anxiety score (Spielberger questionary: composed of 20 items rated from 1 to 4 points) | Baseline and Aplasia (between day10 and 14 of hopitalization) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score by Spielberger questionary | Difference between the 2 Arms on anxiety score (Spielberger questionary: composed of 20 items rated from 1 to 4 points) | Baseline and day 21 of hospitalization | 
| Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU). | 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. | Baseline, Aplasia and day 21 of hospitalization | 
| Well-being score | Difference between the 2 Arms on well-being score (OMS questionary) | Baseline, Aplasia and day 21 of hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aesthetic care, Transplant, Well-being, Anxiety, Supportive care