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

University Hospital, Lille

Status: Completed

Conditions: Acute Leukemia; Hematopoietic Stem Cell Transplantation (SCT); Aplasia

Treatments: Other: Questionnaire; Other: Aesthetic therapy sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03959007

2017-A03453-50 (Other Identifier)

2017_43

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Control

Active Comparator group

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

Treatment:

Other: Questionnaire

Experimental

Experimental group

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)

Treatment:

Other: Aesthetic therapy sessions

Other: Questionnaire