Assessment and Prevention of Caregiver Burden in Oncology (PREPAC-01)

Institut Cancerologie de l'Ouest

Status: Not yet enrolling

Conditions: Oncology; Caregiver Burden

Treatments: Other: Non-specific nursing support; Other: Specific nursing support

Study type: Interventional

Funder types: Other

Identifiers

NCT05750836

ICO-2022-03

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Specific nursing support

Experimental group

Description:

The caregivers benefit from specific nursing support.

Treatment:

Other: Specific nursing support

No specific nursing support

Active Comparator group

Description:

Caregivers do not receive any specific support from the nurses.

Treatment:

Other: Non-specific nursing support