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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 (ASTERIA)

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aesthetic therapy sessions
Questionnaire
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Leukemia focused on measuring Aesthetic care, Transplant, Well-being, Anxiety, Supportive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
Well-being score
Difference between the 2 Arms on well-being score (OMS questionary)

Full Information

First Posted
April 10, 2019
Last Updated
October 13, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03959007
Brief Title
Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
Acronym
ASTERIA
Official Title
Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Hematopoietic Stem Cell Transplantation (SCT), Aplasia
Keywords
Aesthetic care, Transplant, Well-being, Anxiety, Supportive care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Aesthetic therapy sessions
Intervention Description
Only for experimental arm at 3 times during hospitalization
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Both arm at 3 times during hospitalization
Primary Outcome Measure Information:
Title
Anxiety score by Spielberger questionary
Description
Difference between the 2 Arms on anxiety score (Spielberger questionary: composed of 20 items rated from 1 to 4 points)
Time Frame
Baseline and Aplasia (between day10 and 14 of hopitalization)
Secondary Outcome Measure Information:
Title
Anxiety score by Spielberger questionary
Description
Difference between the 2 Arms on anxiety score (Spielberger questionary: composed of 20 items rated from 1 to 4 points)
Time Frame
Baseline and day 21 of hospitalization
Title
Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU).
Description
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.
Time Frame
Baseline, Aplasia and day 21 of hospitalization
Title
Well-being score
Description
Difference between the 2 Arms on well-being score (OMS questionary)
Time Frame
Baseline, Aplasia and day 21 of hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence Perraudin, IDE
Phone
3 20 44 42 92
Ext
+33
Email
florence.perraudin@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celine Berthon, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Lille
ZIP/Postal Code
59045
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline BERTHON, MD
Phone
+330320444292
Email
celine.berthon@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Florence PERRAUDIN, IDE
Phone
+330320444292
Email
florence.perraudin@chru-lille.fr

12. IPD Sharing Statement

Learn more about this trial

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

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