Cancer
Conditions
Keywords
Supportive care, Snoezelen
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.
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
Interventions
OTHERSnoezelen session
before one of two repeated invasive care
Sponsors
Institut de cancérologie Strasbourg Europe
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1 | immediately after invasive care at Visit 1 | Evaluation using a modified Visual Analog Scales, Oberts, 1984 |
| Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 2 | immediately after invasive care at Visit 2 | Evaluation using a modified Visual Analog Scales, Oberts, 1984 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Numeric visual analog scale (0 to 10) |
| 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 | Numeric visual analog scale (0 to 10) |
| 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 | Numeric visual analog scale (0 to 10) |
Countries
France
Outcome results
None listed