Assessment and Prevention of Caregiver Burden in Oncology
PREPAC-01
1 other identifier
interventional
250
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 28, 2023
February 1, 2023
3.5 years
February 20, 2023
June 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caregiver burden
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
at 6 months post-randomisation
Secondary Outcomes (3)
The level of anxiety/depression of the caregiver
at month 6 (M6) and month 12 (M12) post-randomisation.
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.
Study Arms (2)
Specific nursing support
EXPERIMENTALThe caregivers benefit from specific nursing support.
No specific nursing support
ACTIVE COMPARATORCaregivers do not receive any specific support from the nurses.
Interventions
* 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
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.
Eligibility Criteria
You may qualify if:
- 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 a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity;
You may not qualify if:
- Patient whose life expectancy is assumed to be \< 6 months;
- Caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia…) or under guardianship.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CH Cholet
Cholet, 49300, France
Centre Antoine Lacassagne
Nice, 06 189, France
Centre Henri Bequerel
Rouen, 76038, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
CH Mémorial de Saint Lo
Saint-Lô, 50000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Céline THOMAS, Nurse
Institut de Cancérologie de l'Ouest
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 2, 2023
Study Start
July 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 28, 2023
Record last verified: 2023-02