Assessment and Prevention of Caregiver Burden in Oncology
NCT ID: NCT05750836
Last Updated: 2023-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2023-07-31
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Specific nursing support
The caregivers benefit from specific nursing support.
Specific nursing support
* 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
No specific nursing support
Caregivers do not receive any specific support from the nurses.
Non-specific nursing support
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.
Interventions
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Specific nursing support
* 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
Non-specific nursing support
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
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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Céline THOMAS, Nurse
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de l'Ouest
Locations
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CH Cholet
Cholet, , France
Centre Antoine Lacassagne
Nice, , France
Centre Henri Bequerel
Rouen, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
CH Mémorial de Saint Lo
Saint-Lô, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICO-2022-03
Identifier Type: -
Identifier Source: org_study_id
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