Back to resultsNursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk (TANGO)
Primary Purpose
Exhaustion, Geriatric Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phone nursing follow-up
Sponsored by
About this trial
This is an interventional prevention trial for Exhaustion focused on measuring Cancer, Patient, Oncology, Caregiver
Eligibility Criteria
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
Sites / Locations
- Unité de Coordination Régionale en Oncogériatrie - Hôpital de HautepierreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caregiver of cancer patient followed in geriatric oncology
Arm Description
caregiver of cancer patient with 70 years old or more, for which a treatment is planned, along with their long term evolution
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT02551965
First Posted
September 7, 2015
Last Updated
July 27, 2020
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02551965
Brief Title
Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk
Acronym
TANGO
Official Title
Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exhaustion, Geriatric Disorder
Keywords
Cancer, Patient, Oncology, Caregiver
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caregiver of cancer patient followed in geriatric oncology
Arm Type
Experimental
Arm Description
caregiver of cancer patient with 70 years old or more, for which a treatment is planned, along with their long term evolution
Intervention Type
Other
Intervention Name(s)
Phone nursing follow-up
Intervention Description
From the day of geriatric cancer patient's consultation, nurses will identify caregiver and will follow them by phone (caregiver) during 6 months
Primary Outcome Measure Information:
Title
Standard collection of sociodemographic caregivers features
Description
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.
Time Frame
6 months
Title
Standard collection of economic caregivers features
Description
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.
Time Frame
6 months
Title
Standard collection of physical health caregivers features
Description
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.
Time Frame
6 months
Title
Standard collection of psychological health caregivers features
Description
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.
Time Frame
6 months
Title
Standard collection of caregivers support frequency
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The exhaustion level felt by caregiver is assessed with Mini-Zarit scale
Description
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months
Time Frame
6 months
Title
Medium delay of caregiver exhaustion apparition is assessed with Mini-Zarit scale
Description
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
Time Frame
6 months
Title
Factors associated with medium delay of caregiver exhaustion apparition are determined with caregiver and patient features
Description
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Laudamy
Phone
+33 3 88 11 66 88
Email
anne.laudamy@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
anatta Razafimanantsoa
Phone
+ 33 3 88 11 54 14
Email
anatta.razafimanantsoa@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien HEITZ, MD
Organizational Affiliation
Strasbourg's University Hospitals - UCROG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien HEITZ, PH
Phone
03 88 12 86 57
Email
damien.heitz@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Gwenaelle BOSSU
Phone
03 88 12 86 57
Email
gwenaelle.bossu@chru-strasbourg.fr
12. IPD Sharing Statement
Learn more about this trial
Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk
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