Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care

Study Overview
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Brief Summary
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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
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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

Official Title
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Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care (SNOEZELEN)

Conditions
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Cancer

Intervention / Treatment
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* Other: Snoezelen session


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Visit 1: with Snoezelen session before invasive care Visit 2: standard care (=without Snoezelen session) before invasive care | Other: Snoezelen session<br>* before one of two repeated invasive care<br>|
| Experimental: Arm B<br>Visit 1: standard care (=without Snoezelen session) before invasive care Visit 2: with Snoezelen session before invasive care | Other: Snoezelen session<br>* before one of two repeated invasive care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1 | Evaluation using a modified Visual Analog Scales, Oberts, 1984 | immediately after invasive care at Visit 1 | 
| Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2 | Evaluation using a modified Visual Analog Scales, Oberts, 1984 | immediately after invasive care at Visit 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient perceived pain, with or without Snoezelen session | Numeric visual analog scale (0 to 10) | 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 | 
| Change in patient perceived anxiety, with or without Snoezelen session | Numeric visual analog scale (0 to 10) | 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 | 
| Comparing relationship between patient and caregiver, with or without Snoezelen session | Numeric visual analog scale (0 to 10) | immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive care, Snoezelen