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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67033
    • Institut de cancérologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Supportive care; Snoezelen
• Other Study ID Numbers: 2020-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No