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

NCT02551965 | Unknown DMC

• 1 other identifier: 6116
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Exhaustion; Geriatric Disorder

Keywords

Cancer; Patient; Oncology; Caregiver

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• The exhaustion level felt by caregiver is assessed with Mini-Zarit scale

  6 months

• Medium delay of caregiver exhaustion apparition is assessed with Mini-Zarit scale

  6 months

• Factors associated with medium delay of caregiver exhaustion apparition are determined with caregiver and patient features

  6 months

Study Arms (1)

Caregiver of cancer patient followed in geriatric oncology

EXPERIMENTAL

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

Interventions

Phone nursing follow-up OTHER

From the day of geriatric cancer patient's consultation, nurses will identify caregiver and will follow them by phone (caregiver) during 6 months

Caregiver of cancer patient followed in geriatric oncology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Damien HEITZ, MD

  Strasbourg's University Hospitals - UCROG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Laudamy

CONTACT

+33 3 88 11 66 88; anne.laudamy@chru-strasbourg.fr

anatta Razafimanantsoa

CONTACT

+ 33 3 88 11 54 14; anatta.razafimanantsoa@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 16, 2015
• Study Start: January 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

FR (1)