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

April 9, 2018 updated by: Rathi Mahendran, National University, Singapore

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119228
        • Recruiting
        • Department of Psychological Medicine, NUS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Family cancer caregiver - defined as a family member who lends physical, emotional or other support to someone at any time during cancer treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needs of family cancer caregivers
Time Frame: One year
Needs Assessment of Family Caregivers-Cancer (NAFC-C) questionnaire
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ANTICIPATED)

February 28, 2019

Study Completion (ANTICIPATED)

February 28, 2019

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (ACTUAL)

March 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017/00029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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