Clinical trial NCT04783363: Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care
Official title: Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care (SNOEZELEN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Supportive care
Snoezelen
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a monocentric, comparative, open-label, randomized, crossover study enrolling patients hospitalized in Strasbourg Europe Cancerology Institute, receiving repeated invasive care for cancer treatment.

The purpose of this study is to compare the satisfaction of patients, regarding their perception of care, with or without Snoezelen session.

Detailed description: Patients will followed during two visits for a repeated invasive care. They will be randomized to two groups in a 1:1 ratio.

Crossover plan and arms are described as follow:

Arm A : Visit 1 with Snoezelen session before invasive care and Visit 2 without Snoezelen session before invasive care (standard care)

Arm B : Visit 1 without Snoezelen session before invasive care (standard care) and Visit 2 with Snoezelen session before invasive care

Eligibility criteria: Inclusion Criteria:

* Patients treated for cancer and hospitalized for invasive care
* Two programmed hospitalization for repeated care
* Patients receiving one of the following invasive care: Huber needle application (transfusion, parenteral nutrition), complex wound dressing, intrathecal chemotherapy, ascites fluid or pleural puncture
* Patients must be ≥ 18 years old
* Performance Status ≤ 3
* Absence of psychiatric disorder impairing follow-up
* Ability to speak, understand, write and read French
* Signed informed consent from the patient
* Affiliation to social security system

Exclusion Criteria:

* Patients presenting infectious symptoms requiring isolation
* Patients \< 18 years old or patients ≥ 18 years old under supervision
* Patients placed under judicial protection or guardianship
* Women that are pregnant or breast-feeding

Primary outcomes:
measure: Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1
timeFrame: immediately after invasive care at Visit 1
measure: Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2
timeFrame: immediately after invasive care at Visit 2
Secondary outcomes:
measure: Change in patient perceived pain, with or without Snoezelen session
timeFrame: At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°1; At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°2
measure: Change in patient perceived anxiety, with or without Snoezelen session
timeFrame: At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°1; At admission (i.e. before Snoezelen session, if applicable) and immediately after invasive care at Visit n°2
measure: Comparing relationship between patient and caregiver, with or without Snoezelen session
timeFrame: immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References: