Assessment and Prevention of Caregiver Burden in Oncology

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.

NCT Number	NCT05750836
Lead Sponsor	Institut Cancerologie de l'Ouest
Conditions	Oncology, Caregiver Burden
Enrollment	250 participants
Start Date	2023-07
Primary Completion	2027-01 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2023-06-28