Clinical Research Directory
Browse clinical research sites, groups, and studies.
Assessment and Prevention of Caregiver Burden in Oncology
Sponsor: Institut Cancerologie de l'Ouest
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
Conditions
Interventions
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
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