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

NCT04783363 | Completed

• 1 other identifier: 2020-012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Supportive care; Snoezelen

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in patient perceived pain, with or without Snoezelen session

  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

  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

  immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2

Study Arms (2)

Arm A

EXPERIMENTAL

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

Other: Snoezelen session

Arm B

EXPERIMENTAL

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

Other: Snoezelen session

Interventions

Snoezelen session OTHER

before one of two repeated invasive care

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 5, 2021
• Study Start: April 12, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

FR (1)