CancerONCOTACTNCT03946397
Impact of Multisensory Hand Massage on the Well-being of Cancer Patients
A study testing Mulstisensory massage in people with Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators wish to study the impact of a multisensory hand massage on the immediate well-being of cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Mulstisensory massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2019to 11 Oct 2022
- 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
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient treated in the oncology department of CHU Nimes for any form of cancer with an EValuation Immédiate du Bien-Etre (EVIBE) score of 3 or lower
Who cannot join
- The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient allergic to the massage oil
- Patients with visual or auditory problems
Show all 10Show fewer
- Patients with an infection resulting in hyperthermia
- Patient with hematoma on the hand
- Patient with dermatological problems or painful areas on the hands
- Patients with an EVIBE score greater than 3
Trial locations and contacts
1 site in 1 country.
About this study
The investigators wish to study the impact of a multisensory hand massage on the immediate well-being of cancer patients.
- Conditions
- Cancer
- Being tested
- Mulstisensory massage
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulstisensory massageOther
7 minutes of hand massage followed by multisensory immersion (lights and music) for 23 minutes
| Study group | Role | What they receive |
|---|---|---|
| Multisensory massage | Experimental | Not described Receives: Other: Mulstisensory massage |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in well-being following multisensory massage
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
Measured: 30 minutes
Secondary outcomes (8)
Well-being following multisensory massage
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
Measured: 2 hours
Well-being following multisensory massage
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
Measured: 4 hours
Well-being following multisensory massage
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
Measured: 6 hours
Well-being following multisensory massage
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
Measured: 8 hours
Patient anxiety
State Trait Anxiety Inventory (STAI)
Measured: Immediately prior to treatment
Patient anxiety
State Trait Anxiety Inventory (STAI)
Measured: 30 minutes
Patient anxiety
State Trait Anxiety Inventory (STAI)
Measured: 8 hours
Satisfaction of staff performing the multisensory massage
Custom-built questionnaire; 11 questions on satisfaction at work on a 10-point scale (not at all - enormously)
Measured: End of inclusions (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start17 Sep 2019
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Why it stopped: Inclusion issues
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Houede, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946397
- Sponsor's protocol ID
- APIRES/2018/IP-01
- Acronym
- ONCOTACT
- Status last verified
- Sep 2022
- First submitted
- 9 May 2019
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multisensory Hand Massage on the Well-being of Cancer Patients
- ClinicalTrials.gov ID
- NCT03946397
- Acronym / sponsor ID
- ONCOTACT / APIRES/2018/IP-01
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion issues
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 10 May 2019 (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.
The investigators wish to study the impact of a multisensory hand massage on the immediate well-being of cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory massage | Experimental | Other: Mulstisensory massage |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient treated in the oncology department of CHU Nimes for any form of cancer with an EValuation Immédiate du Bien-Etre (EVIBE) score of 3 or lower
Key exclusion criteria (10 listed)
- The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient allergic to the massage oil
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 |
|---|---|---|
| Mulstisensory massage7 minutes of hand massage followed by multisensory immersion (lights and music) for 23 minutes | Other | Multisensory massage |
Primary outcome
Change in well-being following multisensory massage
Time frame: 30 minutes
EValuation Immédiate du Bien-Etre (EVIBE) questionnaire: 1-5 pictorial scale with 1 being lowest
8 secondary outcomes
Well-being following multisensory massage
Time frame: 2 hours
Well-being following multisensory massage
Time frame: 4 hours
Well-being following multisensory massage
Time frame: 6 hours
Well-being following multisensory massage
Time frame: 8 hours
Patient anxiety
Time frame: Immediately prior to treatment
Patient anxiety
Time frame: 30 minutes
Patient anxiety
Time frame: 8 hours
Satisfaction of staff performing the multisensory massage
Time frame: End of inclusions (12 months)
Results and safety
The study was stopped early (reason given: Inclusion issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Nadine Houede, MD principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulstisensory massage in people with Cancer, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Nov 2022. 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 was stopped early (reason given: Inclusion issues). Results are not available in the source record.
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?
Change in well-being following multisensory massage (time frame: 30 minutes). 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 Nov 2022.