Clinical trial NCT04856332: Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Long-term protective isolation
Patient-child relationship
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age≥ 18
* Patient with at least one child aged 15 or under
* Pathology requiring a prolonged hospitalization in protective isolation
* Consent dated and signed

Exclusion Criteria:

* Impaired cognitive functions
* Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4
* Difficulties in speaking and understanding French
* Patient under guardianship or curatorship

Primary outcomes:
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
timeFrame: Through study completion, an average of 3 months
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
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children)
timeFrame: Through study completion, an average of 3 months
measure: Evaluation of patient's satisfaction
timeFrame: Through study completion, an average of 3 months
measure: Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation)
timeFrame: Through study completion, an average of 3 months
measure: Evaluation of patient's experience of hospitalisation
timeFrame: Through study completion, an average of 3 months
measure: 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
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Centre Leon Berard
name: GUILLERMIN Yann, MD
role: PRINCIPAL_INVESTIGATOR
References: