Clinical trial NCT03959007: Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
Official title: Impact of Supportive Care on the Experience of Hospitalization of Patients Staying in the Protected Area of the Department of Blood Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Leukemia
Hematopoietic Stem Cell Transplantation (SCT)
Aplasia
Keywords: Aesthetic care
Transplant
Well-being
Anxiety
Supportive care
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility 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

Primary outcomes:
measure: Anxiety score by Spielberger questionary
timeFrame: Baseline and Aplasia (between day10 and 14 of hopitalization)
Secondary outcomes:
measure: Anxiety score by Spielberger questionary
timeFrame: Baseline and day 21 of hospitalization
measure: Quality of Life Assessment using the Functional Assessment of Cancer Therapy-Leukemia (FACT-LEU).
timeFrame: Baseline, Aplasia and day 21 of hospitalization
measure: Well-being score
timeFrame: Baseline, Aplasia and day 21 of hospitalization
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Lille
name: Celine Berthon, MD
role: PRINCIPAL_INVESTIGATOR
References: