Clinical trial NCT05750836: Assessment and Prevention of Caregiver Burden in Oncology
Official title: Assessment and Prevention of Caregiver Burden in Oncology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oncology
Caregiver Burden
Keywords: Nurse
Supportive Care
Zarit scale
Caregiver Burden
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Caregiver burden
timeFrame: at 6 months post-randomisation
Secondary outcomes:
measure: The level of anxiety/depression of the caregiver
timeFrame: at month 6 (M6) and month 12 (M12) post-randomisation.
measure: Caregiver's quality of life
timeFrame: at month 6 (M6) and month 12 (M12) post-randomisation.
measure: Caregiver's satisfaction
timeFrame: at month 6 (M6) and month 12 (M12) post-randomisation.
Other outcomes:
Locations:
city: Cholet
country: France
facility: CH Cholet
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Rouen
country: France
facility: Centre Henri Bequerel
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Saint Lo
country: France
facility: CH Mémorial de Saint Lo
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Céline THOMAS, Nurse
role: PRINCIPAL_INVESTIGATOR
References: