CancerSNOEZELENNCT04783363
Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care
A study testing Snoezelen session in people with Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Snoezelen session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Ability to speak, understand, write and read French
- Signed informed consent from the patient
- Affiliation to social security system
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer
- Being tested
- Snoezelen session
- Keywords
- Supportive care, Snoezelen
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snoezelen sessionOther
before one of two repeated invasive care
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | * Visit 1: with Snoezelen session before invasive care
* Visit 2: standard care (=without Snoezelen session) before invasive care Receives: Other: Snoezelen session |
| Arm B | Experimental | * Visit 1: standard care (=without Snoezelen session) before invasive care
* Visit 2: with Snoezelen session before invasive care Receives: Other: Snoezelen session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: immediately after invasive care at Visit 2
Secondary outcomes (3)
Change in patient perceived pain, with or without Snoezelen session
Numeric visual analog scale (0 to 10)
Measured: 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)
Measured: 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)
Measured: immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start12 Apr 2021
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783363
- Sponsor's protocol ID
- 2020-012
- Acronym
- SNOEZELEN
- Status last verified
- Sep 2023
- First submitted
- 25 Feb 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care (SNOEZELEN)
- ClinicalTrials.gov ID
- NCT04783363
- Acronym / sponsor ID
- SNOEZELEN / 2020-012
- Conditions
- Cancer
- Keywords
- Supportive care, Snoezelen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Snoezelen session* Visit 1: with Snoezelen session before invasive care * Visit 2: standard care (=without Snoezelen session) before invasive care |
| Arm B | Experimental | Other: Snoezelen session* Visit 1: standard care (=without Snoezelen session) before invasive care * Visit 2: with Snoezelen session before invasive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snoezelen sessionbefore one of two repeated invasive care | Other | Arm A, Arm B |
Primary outcome
Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1
Time frame: 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
Time frame: immediately after invasive care at Visit 2
Evaluation using a modified Visual Analog Scales, Oberts, 1984
3 secondary outcomes
Change in patient perceived pain, with or without Snoezelen session
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
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
Comparing relationship between patient and caregiver, with or without Snoezelen session
Time frame: immediately after invasive care at Visit 1 ; immediately after invasive care at Visit 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snoezelen session in people with Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction regarding their perception of care quality (with or without Snoezelen session) at Visit 1 (time frame: immediately after invasive care at Visit 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.