Acute Leukemia, Aplasia, Hematopoietic Stem Cell Transplantation (SCT)
Conditions
Keywords
Aesthetic care, Transplant, Well-being, Anxiety, Supportive care
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.
Interventions
OTHERAesthetic therapy sessions
Only for experimental arm at 3 times during hospitalization
OTHERQuestionnaire
Both arm at 3 times during hospitalization
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety score by Spielberger questionary | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety score by Spielberger questionary | 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). | 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 | Baseline, Aplasia and day 21 of hospitalization | Difference between the 2 Arms on well-being score (OMS questionary) |
Countries
France
Outcome results
None listed