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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03081312
Other study ID # 2017/00029
Secondary ID
Status Recruiting
Phase
First received March 7, 2017
Last updated April 9, 2018
Start date March 1, 2017
Est. completion date February 28, 2019

Study information

Verified date January 2018
Source National University, Singapore
Contact Rathi Mahendran, MMed(Psych)
Phone 67725555
Email rathi_mahendran@nuhs.edu.sg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 510
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Singapore Department of Psychological Medicine, NUS Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Needs of family cancer caregivers Needs Assessment of Family Caregivers-Cancer (NAFC-C) questionnaire One year
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