Assessment and Prevention of Caregiver Burden in Oncology
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Cancerologie de l'Ouest
About this trial
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.
Eligibility criteria
Qualifiers
Caregiver designated by the patient;
Caregiver 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;
Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;
Caregiver of a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity;
Disqualifiers
Patient whose life expectancy is assumed to be < 6 months;
Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;
Caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia…) or under guardianship.
Trial design
Treatments tested in this trial
- Specific nursing support
- Non-specific nursing support
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov