NCT05750836

Assessment and Prevention of Caregiver Burden in Oncology

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oncology
• Caregiver Burden

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2023-03-02
• Last updated: 2023-06-28

Locations

5 sites across 1 country: France