Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk

Geriatric Disorder Clinical Trial

— TANGO  

Official title:

Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02551965
• Other study ID #: 6116
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Burnout, Psychological
• Exhaustion
• Geriatric Disorder

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