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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02551965
Other study ID # 6116
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date September 2023

Study information

Verified date July 2020
Source University Hospital, Strasbourg, France
Contact Anne Laudamy
Phone +33 3 88 11 66 88
Email anne.laudamy@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the clinical risk factor of exhaustion, the researchers propose to conduct a prospective observational study during 6 months phone follow up of the caregivers. The recruitment will take place during the oncogeriatric assessment consultation.


Description:

The primary purpose aim to describe the caregiver of patient with 70 years old or more, suffered from cancer and for which a treatment is planned, along with their long term evolution.

The secondary purposes are to :

- Assess the exhaustion level felt by this caregiver

- Assess the medium delay of caregiver exhaustion apparition

- Relate factors associated to the medium delay of caregiver exhaustion apparition during patient chemotherapy and/or radiotherapy treatment


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 2023
Est. primary completion date April 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Caregiver of :

- patient with 70 years old or more, suffered from cancer and receiving specific cancer treatment (chemotherapy or radiotherapy )

- Patient evaluated in a specific comprehensive oncogeriatric assessment

- informed patient given a non-opposition form

- Patient affiliated to a social protection scheme

- Informed consent given by the caregiver

Exclusion Criteria:

- Patient and caregiver under judicial protection

- Caregiver with understanding difficulties with French language

- Psychological, familial, social or geographic conditions that avoid a good clinical trial continuity

- Patient with = 18 years old

- Caregiver and patient with significant cognitive troubles

- Caregiver and patient located in institution during inclusion period

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Phone nursing follow-up
From the day of geriatric cancer patient's consultation, nurses will identify caregiver and will follow them by phone (caregiver) during 6 months

Locations

Country Name City State
France Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standard collection of sociodemographic caregivers features subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The sociodemographic features will be reported during this period, depending on patient disease and caregiver tasks. 6 months
Primary Standard collection of economic caregivers features subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The economic features will be reported during this period, depending on patient disease and caregiver tasks. 6 months
Primary Standard collection of physical health caregivers features subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The physical health features will be reported during this period, depending on patient disease and caregiver tasks. 6 months
Primary Standard collection of psychological health caregivers features subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The psychological health features will be reported during this period, depending on patient disease and caregiver tasks. 6 months
Primary Standard collection of caregivers support frequency subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The caregivers support frequency will be reported during this period, depending on patient disease and caregiver tasks. 6 months
Secondary The exhaustion level felt by caregiver is assessed with Mini-Zarit scale subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months 6 months
Secondary Medium delay of caregiver exhaustion apparition is assessed with Mini-Zarit scale An exhaustion is noticed when caregiver score is = 2 on Mini-Zarit scale. However, the medium delay of caregiver exhaustion apparition is also assessed with an increasing of 2 points from caregiver baseline score on mini-Zarit scale.
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months
6 months
Secondary Factors associated with medium delay of caregiver exhaustion apparition are determined with caregiver and patient features subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months 6 months
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