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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT02551965
Collaborator
(none)
200
1
1
92
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Phone nursing follow-up
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre Strasbourg France 67098

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Damien HEITZ, MD, Strasbourg's University Hospitals - UCROG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02551965
Other Study ID Numbers:
  • 6116
First Posted:
Sep 16, 2015
Last Update Posted:
Jul 28, 2020
Last Verified:
Jul 1, 2020
Keywords provided by University Hospital, Strasbourg, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2020