Clinical trial · Interventional
Assessment and Prevention of Caregiver Burden in Oncology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Caregiver Burden | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-specific nursing support | Other | — | UNRESOLVED |
| Specific nursing support | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Specific nursing support
- description
- The caregivers benefit from specific nursing support.
- interventionNames
- Other: Specific nursing support
- type
- ACTIVE_COMPARATOR
- label
- No specific nursing support
- description
- Caregivers do not receive any specific support from the nurses.
- interventionNames
- Other: Non-specific nursing support
Primary outcomes (1)
- measure
- Caregiver burden
- timeFrame
- at 6 months post-randomisation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available