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

Acute Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03959007
• Other study ID #: 2017_43
• Secondary ID: 2017-A03453-50
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: March 2024

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: Florence Perraudin, IDE
• Phone: 3 20 44 42 92
• Email: florence.perraudin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Leukemia
• Aplasia
• Hematologic Diseases
• Hematopoietic Stem Cell Transplantation (SCT)

Intervention

Other:
• Aesthetic therapy sessions
Only for experimental arm at 3 times during hospitalization
• Questionnaire
Both arm at 3 times during hospitalization

Locations

Country	Name	City	State
France	University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Well-being score	Difference between the 2 Arms on well-being score (OMS questionary)	Baseline, Aplasia and day 21 of hospitalization