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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02285296 |
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Date of registration:
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04/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Needs and Burden of Family Caregivers of Older Adults With Cancer
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Scientific title:
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The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants |
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Date of first enrolment:
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December 11, 2014 |
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Target sample size:
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78 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02285296 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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GAXATTE Cédric, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Lille |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Identification of a patient / caregiver couple
- Be the primary caregiver for at least one month of a subject
- Age =70 years
- With cancer
- Who benefited a comprehensive geriatric assessement at University Lille Hospital
or Centre Oscar Lambret
- Affiliated to a social security or receiving an equivalent system of social
protection
- 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:
- Caregiver < 18 years old
- Legal inability or restricted legal ability
- Inability to attend or comply with interventions or follow-up scheduling, disability
or difficulty preventing a proper understanding of trial instructions
- patient's life expectancy less than 6 months (clinical assessment)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Oncologic Disorders
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Tumor
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Intervention(s)
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Other: personalized support program
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Primary Outcome(s)
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change in caregiver burden (22 items Zarit Burden Interview)
[Time Frame: 6 months]
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Secondary Outcome(s)
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Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score)
[Time Frame: baseline evaluation]
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Time spent for the development and implementation of the caregiver personalized support plan
[Time Frame: 6 months]
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Link between caregiver burden and geriatric syndromes
[Time Frame: baseline and 6 months]
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Link between caregiver burden and stage of cancer / time from cancer diagnosis
[Time Frame: baseline]
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Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP
[Time Frame: 6 months]
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psychosocial characteristics of caregivers of patients with cancer
[Time Frame: baseline and 6 months]
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Secondary ID(s)
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2013_40
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2014-A00018-39
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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