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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00018-39 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Centre Oscar Lambret | OTHER |
| University of Lille Nord de France | OTHER |
| National Cancer Institute, France | OTHER_GOV |
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Elderly cancer patients need more help from their relatives and for longer than young adults.
Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.
Scientific context Elderly cancer patients need more help from their relatives and for longer than young adults. The person who takes primary responsibility for someone who cannot care fully for themselves is called the primary caregiver.
A recent personal study concerning elderly cancer patients caregivers show that most caregivers reported high or moderate levels of psychological distress, with an impact on their own health status.
In addition, family caregivers often report deficits in information about the disease, in training and skills related to their patients' care, and a lack of assistance from healthcare professionals.
The ability of the primary caregiver to meet the medical, material and emotional needs of the patient depends on their own resources (psychological, physical, intellectual, physical, financial) and on the diversity of their social network, but it also depends on the quality of the personalized support program (including information and training) that has been established for them.
Research hypotheses
Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.
Intervention description
Prospective, interventional, randomized trial, with 118 patients in each group:
All the "couples patient / caregiver' will benefit initially from:
Randomization will be stratified according to:
Intervention Stage 1: A semi-structured interview centered on the caregiver's needs (COAT tool) Stage 2: guided questionnaires to assess the psychosocial situation of caregivers Stage 3: implementation of a multi-component PSP (information, counseling, listening time, training to help overcome their difficulties as a caregiver, planning for future care) Stage 4: at least one monthly phone interview Stage 5: 6 months follow up on the psychosocial characteristics of caregivers
Expected results in public health Our study will help to better define the way to take better account of the needs of the helper / helped couple, and reinforce the role of the coordinating nurse in the care pathways.
If our hypotheses can confirmed that there is a link between the caregivers needs and the social determinants of health and that the intervention has a positive impact on the caregivers burden and stress, it will suggest that this intervention not only acts favorably on social inequalities in health, but it can help reduce health care costs, as the caregiver exhaustion increases the risk of health expenditure (drug consumption, hospitalization of the patient and of the caregiver).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control arm | No Intervention | usual care | |
| personalized support program | Experimental | interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| personalized support program | Other | interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| change in caregiver burden (22 items Zarit Burden Interview) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score) | baseline evaluation | |
| psychosocial characteristics of caregivers of patients with cancer | Caregiver Reaction Assessment (CRA) Carers' Assessment of Managing Index (CAMI) Inventory of social support (ISSB) Hospital Anxiety and Depression Scale (HADS) Cognitive Inventory of Subjective Distress (CISD) Subjective well-being scale (BES) |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between needs and EPICES score | baseline |
Inclusion Criteria:
Identification of a patient / caregiver couple
Be the primary caregiver for at least one month of a subject
caregiver able to understand the nature, purpose and methodology of the study
caregiver able to cooperate in interviews and questionnaires
Written informed consent of the caregiver and the cancer patient provided before any study specific procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GAXATTE Cédric, MD | University Hospital, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | France | ||||
| University hospital, Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26452199 | Result | Horn M, D'Hondt F, Vaiva G, Thomas P, Pins D. Categorical perception of familiarity: Evidence for a hyper-familiarity in schizophrenia. J Psychiatr Res. 2015 Dec;71:63-9. doi: 10.1016/j.jpsychires.2015.09.015. Epub 2015 Sep 30. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| baseline and 6 months |
| Link between caregiver burden and geriatric syndromes | baseline and 6 months |
| Link between caregiver burden and stage of cancer / time from cancer diagnosis | baseline |
| Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP | 6 months |
| Time spent for the development and implementation of the caregiver personalized support plan | 6 months |
| Lille |
| France |