免费获得国外相关药品，最快 1 个工作日回馈药物信息
Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases (ASTERIA)
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 |
| 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 |
| 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
|
- 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)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Florence Perraudin, IDE | 3 20 44 42 92 ext +33 | florence.perraudin@chru-lille.fr |
| 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 | |
| Principal Investigator: | Celine Berthon, MD | University Hospital, Lille |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 10, 2019 | ||||
| First Posted Date ICMJE | May 22, 2019 | ||||
| Last Update Posted Date | August 26, 2020 | ||||
| Actual Study Start Date ICMJE | March 15, 2019 | ||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases | ||||
| Official Title ICMJE | Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Supportive Care |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
70 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 2021 | ||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03959007 | ||||
| Other Study ID Numbers ICMJE | 2017_43 2017-A03453-50 ( Other Identifier: ID-RCB number, ANSM ) |
||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | University Hospital, Lille | ||||
| Study Sponsor ICMJE | University Hospital, Lille | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| PRS Account | University Hospital, Lille | ||||
| Verification Date | August 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
