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

NCT03959007 | Completed

• 2 other identifiers: 2017_432017-A03453-50
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Aesthetic care; Transplant; Well-being; Anxiety; Supportive care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anxiety score by Spielberger questionary

  Baseline and day 21 of hospitalization

• Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU).

  Baseline, Aplasia and day 21 of hospitalization

• Well-being score

  Baseline, Aplasia and day 21 of hospitalization

Study Arms (2)

Control

ACTIVE COMPARATOR

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

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: Aesthetic therapy sessions; Other: Questionnaire

Interventions

Questionnaire OTHER

Both arm at 3 times during hospitalization

Control; Experimental

Aesthetic therapy sessions OTHER

Only for experimental arm at 3 times during hospitalization

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient affiliated to and covered by social security for standard care

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

University Hospital

Lille, 59045, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Celine Berthon, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: May 22, 2019
• Study Start: March 15, 2019
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)