Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation

Cancer Clinical Trial

— VIK-e2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856332
• Other study ID #: ET19-193 - VIK-e2
• Status: Recruiting
• Start date: February 24, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2022
• Source: Centre Leon Berard
• Contact: METZGER Séverine
• Phone: +33 4.78.78.27.86
• Email: severine.metzger[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2023
• Est. primary completion date: June 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Telepresence robot installed at child's home during parent's hospitalisation
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)

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Lyon
France	Centre Leon Berard	Lyon
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an average of 3 months
Primary	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	Through study completion, an average of 3 months
Secondary	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	Through study completion, an average of 3 months
Secondary	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	Through study completion, an average of 3 months
Secondary	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	Through study completion, an average of 3 months
Secondary	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	Through study completion, an average of 3 months
Secondary	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	Through study completion, an average of 3 months