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

Institut de cancérologie Strasbourg Europe

Status: Completed

Conditions: Cancer

Treatments: Other: Snoezelen session

Study type: Interventional

Funder types: Other

Identifiers

NCT04783363

2020-012

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Arm A

Experimental group

Description:

* Visit 1: with Snoezelen session before invasive care * Visit 2: standard care (=without Snoezelen session) before invasive care

Treatment:

Other: Snoezelen session

Arm B

Experimental group

Description:

* Visit 1: standard care (=without Snoezelen session) before invasive care * Visit 2: with Snoezelen session before invasive care

Treatment:

Other: Snoezelen session