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

Not Applicable

• Conditions: Geriatric Disorder; Exhaustion
• Interventions: Other: Phone nursing follow-up

• Registration Number: NCT02551965
• Lead Sponsor: University Hospital, Strasbourg, France

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

Study Timeline

• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Study Start: 2016-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28
• Primary Completion: 2023-04
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caregiver of cancer patient followed in geriatric oncology	Phone nursing follow-up	caregiver of cancer patient with 70 years old or more, for which a treatment is planned, along with their long term evolution

Primary Outcome Measures

Name	Time	Method
Standard collection of caregivers support frequency	6 months	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.
Standard collection of sociodemographic caregivers features	6 months	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	6 months	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	6 months	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	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Factors associated with medium delay of caregiver exhaustion apparition are determined with caregiver and patient features	6 months	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	6 months	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
The exhaustion level felt by caregiver is assessed with Mini-Zarit scale	6 months	subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months

Trial Locations

Locations (1)

Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre; 🇫🇷 Strasbourg, France