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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 (ASTERIA)

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ClinicalTrials.gov Identifier: NCT03959007
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Acute Leukemia Hematopoietic Stem Cell Transplantation (SCT) Aplasia Other: Aesthetic therapy sessions Other: Questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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: Aesthetic therapy sessions
Only for experimental arm at 3 times during hospitalization

Other: Questionnaire
Both arm at 3 times during hospitalization




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959007


Contacts
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Contact: Florence Perraudin, IDE 3 20 44 42 92 ext +33 florence.perraudin@chru-lille.fr

Locations
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France
University Hospital Recruiting
Lille, France, 59045
Contact: Céline BERTHON, MD    +330320444292    celine.berthon@chru-lille.fr   
Contact: Florence PERRAUDIN, IDE    +330320444292    florence.perraudin@chru-lille.fr   
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Celine Berthon, MD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03959007     History of Changes
Other Study ID Numbers: 2017_43
2017-A03453-50 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Aesthetic care
Transplant
Well-being
Anxiety
Supportive care
Additional relevant MeSH terms:
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Hematologic Diseases