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FCG-NBC: A Study of Family Caregivers' Needs, Burden of Care and Quality of Life Over the Course of a Cancer Illness

Sponsor
National University, Singapore (Other)
Overall Status
Unknown status
CT.gov ID
NCT03081312
Collaborator
(none)
510
Enrollment
1
Location
24
Anticipated Duration (Months)
21.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research will determine (a) the unmet needs of family caregivers of adult cancer patients and (b) determine the impact on stress, care burden and quality of life.

A cross-sectional questionnaire methodology will be used to answer the research questions. 510 family caregivers at different stages of patients' cancer journey will be recruited. The study duration is expected to take two years. Research findings will address the knowledge gap of caregivers' needs and stress, burden and quality of life and support plans to help caregivers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The literature suggests that caregivers have unique psychological, emotional and lifestyle needs but there is a paucity of such information of caregivers in Singapore. As this study is exploratory, no a priori hylothesis has been made. The theoretical framework guiding this research is Fulfillment Theory in which the existence and perception of needs and need fulfillment are hypothesized to be antecedents to the experience of satisfaction about care.

    A cross-sectional questionnaire methodology will be used to answer the research questions. Caregivers in this study are defined as: a family member who lends physical, emotional or other support to someone at any time during the cancer journey. A power calculation was not done, instead the sample size of 510 was based on what may be practically achievable and feasible for the duration of the short-term quantitative study. Descriptive statistics will be used to characterize the distribution of socio-demographic characteristics and caregiver-related information. Regression analysis will be used to evaluate difference in overall and domain specific needs across selected characteristics. Problems identified by caregivers will be dichotomized as present or absent and chi-square tests will be used to evaluate associations with selected characteristics.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    510 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Study of Family Caregivers' Needs, Burden of Care and Quality of Life Over the Course of a Cancer Illness
    Actual Study Start Date :
    Mar 1, 2017
    Anticipated Primary Completion Date :
    Feb 28, 2019
    Anticipated Study Completion Date :
    Feb 28, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Needs of family cancer caregivers [One year]

      Needs Assessment of Family Caregivers-Cancer (NAFC-C) questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    an adult providing care for a familyt member with cancer aged between 21 and 90 years and willing to participate in the study

    Exclusion Criteria:

    caregiving adults who are not family members and not willing to particfipate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Psychological Medicine, NUS Singapore Singapore 119228

    Sponsors and Collaborators

    • National University, Singapore

    Investigators

    • Principal Investigator: Rathi Mahendran, MMed(Psych), Department of Psychological medicine, NUS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rathi Mahendran, Principal Investigator, National University, Singapore
    ClinicalTrials.gov Identifier:
    NCT03081312
    Other Study ID Numbers:
    • 2017/00029
    First Posted:
    Mar 16, 2017
    Last Update Posted:
    Apr 10, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rathi Mahendran, Principal Investigator, National University, Singapore
    Family Cancer Caregivers,
    Needs
    Burden of Care
    Quality of Life

    Study Results

    No Results Posted as of Apr 10, 2018