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

October 13, 2022 updated by: University Hospital, Lille

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Questionnaire
Both arm at 3 times during hospitalization
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)
Other: Questionnaire
Both arm at 3 times during hospitalization
Other: Aesthetic therapy sessions
Only for experimental arm at 3 times during hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and Aplasia (between day10 and 14 of hopitalization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and day 21 of hospitalization
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.
Baseline, Aplasia and day 21 of hospitalization
Well-being score
Time Frame: Baseline, Aplasia and day 21 of hospitalization
Difference between the 2 Arms on well-being score (OMS questionary)
Baseline, Aplasia and day 21 of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Celine Berthon, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2019

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2024

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (ACTUAL)

May 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_43
  • 2017-A03453-50 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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