ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02285296
Recruitment Status : Terminated (Enrollment problem)
First Posted : November 6, 2014
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Centre Oscar Lambret
University of Lille Nord de France
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

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 or disease Intervention/treatment Phase
Oncologic Disorders Tumor Other: personalized support program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
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
Actual Study Start Date : December 11, 2014
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. Link between caregiver burden (ZBI) and the indicator of precariousness (EPICES score) [ Time Frame: baseline evaluation ]
  2. 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)

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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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


Locations
France
Centre Oscar Lambret
Lille, France
University hospital, Lille
Lille, France
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

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 Posted: November 6, 2014    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
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