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OpenTrials
Completed

NCT Number: NCT03959007

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Lille, 59045, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aesthetic therapy sessions

Other

Only for experimental arm at 3 times during hospitalization

Questionnaire

Other

Both arm at 3 times during hospitalization

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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.

  3. Well-being score

    Time frame: Baseline, Aplasia and day 21 of hospitalization

    Difference between the 2 Arms on well-being score (OMS questionary)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: ASTERIA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 22, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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