Assessment and Prevention of Caregiver Burden in Oncology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oncology
- Sponsor
- Institut Cancerologie de l'Ouest
- Enrollment
- 250
- Locations
- 5
- Primary Endpoint
- Caregiver burden
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Caregiver burden
Time Frame: at 6 months post-randomisation
Comparison in the 2 groups. Burden score is assessed using the ZARIT SCALE. The test consists of 22 questions that the caregiver has to score from 0 to 4, the whole giving a score from 0 to 88. 0 means no burden, 88 means that the burden is severe
Secondary Outcomes
- Caregiver's quality of life(at month 6 (M6) and month 12 (M12) post-randomisation.)
- Caregiver's satisfaction(at month 6 (M6) and month 12 (M12) post-randomisation.)
- The level of anxiety/depression of the caregiver(at month 6 (M6) and month 12 (M12) post-randomisation.)