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Trial Title:
Assessment and Prevention of Caregiver Burden in Oncology
NCT ID:
NCT05750836
Condition:
Oncology
Caregiver Burden
Conditions: Official terms:
Neoplasms
Caregiver Burden
Conditions: Keywords:
Nurse
Supportive Care
Zarit scale
Caregiver Burden
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Specific nursing support
Description:
- 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
Arm group label:
Specific nursing support
Intervention type:
Other
Intervention name:
Non-specific nursing support
Description:
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.
Arm group label:
No specific nursing support
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CH Cholet
Address:
City:
Cholet
Zip:
49300
Country:
France
Contact:
Last name:
Margot NOBLECOURT, MD
Email:
margot.noblecourt@ch-cholet.fr
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06 189
Country:
France
Contact:
Last name:
julie OUDIN, Nurse
Email:
Julie.oudin@nice.unicancer.fr
Facility:
Name:
Centre Henri Bequerel
Address:
City:
Rouen
Zip:
76038
Country:
France
Contact:
Last name:
Amel CONSTANTIN, Nurse
Email:
amel.benchemam@chb.unicancer.fr
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Contact:
Last name:
Céline THOMAS, Nurse
Email:
celine.thomas@ico.unicancer.fr
Facility:
Name:
CH Mémorial de Saint Lo
Address:
City:
Saint Lo
Zip:
50000
Country:
France
Contact:
Last name:
Emillie LEFEVRE, Nurse
Email:
emilie.lefevre@ch-stlo.fr
Start date:
July 2023
Completion date:
June 2027
Lead sponsor:
Agency:
Institut Cancerologie de l'Ouest
Agency class:
Other
Source:
Institut Cancerologie de l'Ouest
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05750836
