Acute LeukemiaASTERIANCT03959007
Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
A study testing Aesthetic therapy sessions and Questionnaire in people with Acute Leukemia and Hematopoietic Stem Cell Transplantation (SCT), run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Hematopoietic Stem Cell Transplantation (SCT), Aplasia
- What is being tested?
- Aesthetic therapy sessions and Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2019to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Aesthetic therapy sessions, Questionnaire
- Keywords
- Aesthetic care, Transplant, Well-being, Anxiety, Supportive care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aesthetic therapy sessionsOther
Only for experimental arm at 3 times during hospitalization
QuestionnaireOther
Both arm at 3 times during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Other: Aesthetic therapy sessions; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and Aplasia (between day10 and 14 of hopitalization)
Secondary outcomes (3)
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)
Measured: Baseline and day 21 of hospitalization
Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU).
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.
Measured: Baseline, Aplasia and day 21 of hospitalization
Well-being score
Difference between the 2 Arms on well-being score (OMS questionary)
Measured: Baseline, Aplasia and day 21 of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start15 Mar 2019
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celine Berthon, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959007
- Sponsor's protocol ID
- 2017_43
- Other IDs
- 2017-A03453-50
- Acronym
- ASTERIA
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
- ClinicalTrials.gov ID
- NCT03959007
- Acronym / sponsor ID
- ASTERIA / 2017_43
- Keywords
- Aesthetic care, Transplant, Well-being, Anxiety, Supportive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: QuestionnaireUsual 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 |
| Experimental | Experimental | Other: Aesthetic therapy sessions, Other: Questionnaire9 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aesthetic therapy sessionsOnly for experimental arm at 3 times during hospitalization | Other | Experimental |
| QuestionnaireBoth arm at 3 times during hospitalization | Other | Control, Experimental |
Primary outcome
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)
3 secondary outcomes
Anxiety score by Spielberger questionary
Time frame: Baseline and day 21 of hospitalization
Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU).
Time frame: Baseline, Aplasia and day 21 of hospitalization
Well-being score
Time frame: Baseline, Aplasia and day 21 of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celine Berthon, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aesthetic therapy sessions and Questionnaire in people with Acute Leukemia and Hematopoietic Stem Cell Transplantation (SCT), run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety score by Spielberger questionary (time frame: Baseline and Aplasia (between day10 and 14 of hopitalization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.