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The Needs and Burden of Family Caregivers of Older Adults With Cancer

This study is currently recruiting participants.
Verified May 2017 by University Hospital, Lille
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285296
First Posted: November 6, 2014
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Centre Oscar Lambret
University of Lille Nord de France
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose

Elderly cancer patients need more help from their relatives and for longer than young adults.

Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.


Condition Intervention
Oncologic Disorders Tumor Other: personalized support program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • change in caregiver burden (22 items Zarit Burden Interview) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score) [ Time Frame: baseline evaluation ]
  • psychosocial characteristics of caregivers of patients with cancer [ Time Frame: baseline and 6 months ]
    Caregiver Reaction Assessment (CRA) Carers' Assessment of Managing Index (CAMI) Inventory of social support (ISSB) Hospital Anxiety and Depression Scale (HADS) Cognitive Inventory of Subjective Distress (CISD) Subjective well-being scale (BES)

  • Link between caregiver burden and geriatric syndromes [ Time Frame: baseline and 6 months ]
  • Link between caregiver burden and stage of cancer / time from cancer diagnosis [ Time Frame: baseline ]
  • Match between caregiver personalized support plan (PSP) objectives and effective implemented PSP [ Time Frame: 6 months ]
  • Time spent for the development and implementation of the caregiver personalized support plan [ Time Frame: 6 months ]

Other Outcome Measures:
  • Relationship between needs and EPICES score [ Time Frame: baseline ]

Estimated Enrollment: 236
Actual Study Start Date: December 11, 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control arm
usual care
Experimental: personalized support program
interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up
Other: personalized support program
interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Identification of a patient / caregiver couple
  • Be the primary caregiver for at least one month of a subject

    • Age ≥70 years
    • With cancer
    • Who benefited a comprehensive geriatric assessement at University Lille Hospital or Centre Oscar Lambret
    • Affiliated to a social security or receiving an equivalent system of social protection
  • caregiver able to understand the nature, purpose and methodology of the study
  • caregiver able to cooperate in interviews and questionnaires
  • Written informed consent of the caregiver and the cancer patient provided before any study specific procedures

Exclusion Criteria:

  • Caregiver < 18 years old
  • Legal inability or restricted legal ability
  • Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
  • patient's life expectancy less than 6 months (clinical assessment)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285296


Contacts
Contact: GAXATTE Cedric, MD cedric.gaxatte@chru-lille.fr

Locations
France
Centre Oscar Lambret Recruiting
Lille, France
Contact: SERVENT Véronique, MD       v-servent@o-lambret.fr   
Principal Investigator: SERVENT Véronique, MD         
University hospital, Lille Recruiting
Lille, France
Principal Investigator: GAXATTE Cédric, MD         
Sub-Investigator: PUISSIEUX François, Md, PhD         
Sponsors and Collaborators
University Hospital, Lille
Centre Oscar Lambret
University of Lille Nord de France
National Cancer Institute, France
Investigators
Study Chair: GAXATTE Cédric, MD University Hospital, Lille
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02285296     History of Changes
Other Study ID Numbers: 2013_40
2014-A00018-39 ( Other Identifier: ID-RCB number, ANSM )
First Submitted: November 4, 2014
First Posted: November 6, 2014
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
geriatric assessment
Caregivers
Needs Assessment
oncology nursing
frail elderly
Medical, psychologic and sociologic approach