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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

NCT ID: NCT03959007

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2022-10-27

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.

Detailed Description

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Conditions

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Acute Leukemia Hematopoietic Stem Cell Transplantation (SCT) Aplasia

Keywords

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Aesthetic care Transplant Well-being Anxiety Supportive care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Questionnaire

Intervention Type OTHER

Both arm at 3 times during hospitalization

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)

Group Type EXPERIMENTAL

Aesthetic therapy sessions

Intervention Type OTHER

Only for experimental arm at 3 times during hospitalization

Questionnaire

Intervention Type OTHER

Both arm at 3 times during hospitalization

Interventions

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Aesthetic therapy sessions

Only for experimental arm at 3 times during hospitalization

Intervention Type OTHER

Questionnaire

Both arm at 3 times during hospitalization

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celine Berthon, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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University Hospital

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A03453-50

Identifier Type: OTHER

Identifier Source: secondary_id

2017_43

Identifier Type: -

Identifier Source: org_study_id