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

Institut de cancérologie Strasbourg Europe60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

Snoezelen sessionOTHER

before one of two repeated invasive care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: immediately after invasive care at Visit 2

Secondary Outcomes

Change in patient perceived pain, with or without Snoezelen session

Numeric visual analog scale (0 to 10)

Time frame: 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)

Comparing relationship between patient and caregiver, with or without Snoezelen session

Numeric visual analog scale (0 to 10)

Time frame: immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2

Data from ClinicalTrials.gov

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