Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases (ASTERIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03959007|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : August 26, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
Both arm at 3 times during hospitalization
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
Both arm at 3 times during hospitalization
- 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)
- 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)
- 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.
- Well-being score [ Time Frame: Baseline, Aplasia and day 21 of hospitalization ]Difference between the 2 Arms on well-being score (OMS questionary)
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
|Contact: Florence Perraudin, IDE||3 20 44 42 92 ext +email@example.com|
|Principal Investigator:||Celine Berthon, MD||University Hospital, Lille|