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

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.

Study Overview

• Status: Recruiting
• Conditions: Geriatric Disorder; Exhaustion
• Intervention / Treatment: Other: Phone nursing follow-up

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Laudamy; Phone Number: +33 3 88 11 66 88; Email: anne.laudamy@chru-strasbourg.fr
• Study Contact Backup: Name: anatta Razafimanantsoa; Phone Number: + 33 3 88 11 54 14; Email: anatta.razafimanantsoa@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67098
    • Recruiting
    • Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre
    • Contact: Damien HEITZ, PH; Phone Number: 03 88 12 86 57; Email: damien.heitz@chru-strasbourg.fr
    • Contact: Gwenaelle BOSSU; Phone Number: 03 88 12 86 57; Email: gwenaelle.bossu@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caregiver of cancer patient followed in geriatric oncology; caregiver of cancer patient with 70 years old or more, for which a treatment is planned, along with their long term evolution	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Damien HEITZ, MD, Strasbourg's University Hospitals - UCROG

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Patient; Caregiver; Oncology
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 6116