CancerVIK-e2NCT04856332
Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation
An observational study of Cancer, run by Centre Leon Berard at 3 sites in France.
Trial summary
The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Telepresence robot installed at child's home during parent's hospitalisation
- How many people
- 31 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Feb 2021to 3 Jun 2023
- Phase
- Observational
- 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
Study population: Observational prospective study, multicenter of parent-child relationship assessment following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation. This study is based on semi-directed interviews and observations made during patient's hospitalisation and when patient returns at home.
Who may be able to join
- Age≥ 18
- Patient with at least one child aged 15 or under
- Pathology requiring a prolonged hospitalization in protective isolation
- Consent dated and signed
Who cannot join
- Impaired cognitive functions
- Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4
- Difficulties in speaking and understanding French
- Patient under guardianship or curatorship
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Leon Berard
Lyon, 69008
Centre Hospitalier Lyon Sud
Lyon
Institut Paoli Calmettes
Marseille, 13000
About this study
Official title: VIK-e2 - Observational, Multicenter Prospective Study Evaluating Parent-child Relationship with the Setting Up of a Mobile Telepresence Robot for Patients with Children Aged 15 Years or Less and Hospitalised in Long-term Protective Isolation
The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.
Read the detailed description
Telepresence robots are increasingly used as a means of remote communications, especially for teleconsultations and/or access to various public services (cultural events, education, etc.). In the context of long-term hospitalisation, they can be used for various purposes, such as access to cultural events, university activities, contact with patient's home and maintenance of family links. Some studies have analyzed the use of these robots and their effects in academic settings or the suitability of their use with elderly populations for continuing care.
To our knowledge, no study has evaluated the interest for the parent-child relationship of the use of a telepresence robot during the hospitalisation in protective isolation for a long period of a patient with young child(ren).
We propose to conduct this observational, multi-center prospective study aiming at evaluating the parent-child relationship following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation.
- Conditions
- Cancer
- Being tested
- Telepresence robot installed at child's home during parent's hospitalisation
- Keywords
- Cancer, Long-term protective isolation, Patient-child relationship
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepresence robot installed at child's home during parent's hospitalisationOther
Telepresence robot installed at child's home during parent's hospitalisation in long term protective isolation for maintaining parent-child ink (only children aged 15 years or less are concerned)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation
Observation of communications between the hospitalised patient and his/her chid(children) by a specialist in human and social sciences
Measured: Through study completion, an average of 3 months
Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation
Interview with the hospitalised patient (parent) by a specialist in human and social sciences
Measured: Through study completion, an average of 3 months
Secondary outcomes (5)
Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children)
Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences
Measured: Through study completion, an average of 3 months
Evaluation of patient's satisfaction
Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences
Measured: Through study completion, an average of 3 months
Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation)
Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences
Measured: Through study completion, an average of 3 months
Evaluation of patient's experience of hospitalisation
Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences
Measured: Through study completion, an average of 3 months
Evaluation of the impact of the robot's presence at home on the children and the person in charge of the children during patient's hospitalisation
Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start24 Feb 2021
- Primary completion3 Jun 2023
- Study completion3 Jun 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.
- More trials run by Centre Leon BerardThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GUILLERMIN Yann, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856332
- Sponsor's protocol ID
- ET19-193 - VIK-e2
- Acronym
- VIK-e2
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIK-e2 - Observational, Multicenter Prospective Study Evaluating Parent-child Relationship with the Setting Up of a Mobile Telepresence Robot for Patients with Children Aged 15 Years or Less and Hospitalised in Long-term Protective Isolation
- ClinicalTrials.gov ID
- NCT04856332
- Acronym / sponsor ID
- VIK-e2 / ET19-193 - VIK-e2
- Conditions
- Cancer
- Keywords
- Cancer, Long-term protective isolation, Patient-child relationship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 23 Apr 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.
The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.
Detailed description
Telepresence robots are increasingly used as a means of remote communications, especially for teleconsultations and/or access to various public services (cultural events, education, etc.). In the context of long-term hospitalisation, they can be used for various purposes, such as access to cultural events, university activities, contact with patient's home and maintenance of family links. Some studies have analyzed the use of these robots and their effects in academic settings or the suitability of their use with elderly populations for continuing care.
To our knowledge, no study has evaluated the interest for the parent-child relationship of the use of a telepresence robot during the hospitalisation in protective isolation for a long period of a patient with young child(ren).
We propose to conduct this observational, multi-center prospective study aiming at evaluating the parent-child relationship following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Observational prospective study, multicenter of parent-child relationship assessment following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation. This study is based on semi-directed interviews and observations made during patient's hospitalisation and when patient returns at home.
Key inclusion criteria (4 listed)
- Age≥ 18
- Patient with at least one child aged 15 or under
- Pathology requiring a prolonged hospitalization in protective isolation
- Consent dated and signed
Key exclusion criteria (4 listed)
- Impaired cognitive functions
- Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4
- Difficulties in speaking and understanding French
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Telepresence robot installed at child's home during parent's hospitalisationTelepresence robot installed at child's home during parent's hospitalisation in long term protective isolation for maintaining parent-child ink (only children aged 15 years or less are concerned) | Other | – |
Primary outcome
Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation
Time frame: Through study completion, an average of 3 months
Observation of communications between the hospitalised patient and his/her chid(children) by a specialist in human and social sciences
Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation
Time frame: Through study completion, an average of 3 months
Interview with the hospitalised patient (parent) by a specialist in human and social sciences
5 secondary outcomes
Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children)
Time frame: Through study completion, an average of 3 months
Evaluation of patient's satisfaction
Time frame: Through study completion, an average of 3 months
Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation)
Time frame: Through study completion, an average of 3 months
Evaluation of patient's experience of hospitalisation
Time frame: Through study completion, an average of 3 months
Evaluation of the impact of the robot's presence at home on the children and the person in charge of the children during patient's hospitalisation
Time frame: Through study completion, an average of 3 months
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 Feb 2025.
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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.
GUILLERMIN Yann, MD principal investigator
Centre Leon Berard
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Centre Leon Berard at 3 sites 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 4 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation (time frame: Through study completion, an average of 3 months). 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 Feb 2025.