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NOT YET RECRUITING
NCT05750836
NA

Assessment and Prevention of Caregiver Burden in Oncology

Sponsor: Institut Cancerologie de l'Ouest

View on ClinicalTrials.gov

Summary

The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life. Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month. Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support. The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2023-07

Completion Date

2027-06

Last Updated

2023-06-28

Healthy Volunteers

No

Interventions

OTHER

Specific nursing support

* 3 mandatory on-site nursing consultations with the patient's caregiver at inclusion, 6 months and 12 months post-randomisation.The caregivers will complete the questionnaires (Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36, Caregiver's satisfaction). * interviews once a month with a nurse either by phone, on-site consultation or teleconsultation. Nurses assess the general health of the caregiver and Identify the socio-professional situation of the caregiver

OTHER

Non-specific nursing support

Caregivers will only have to complete on site Health indicators, Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36 at inclusion, 6 months and 12 months post-randomisation.

Locations (5)

CH Cholet

Cholet, France

Centre Antoine Lacassagne

Nice, France

Centre Henri Bequerel

Rouen, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

CH Mémorial de Saint Lo

Saint-Lô, France