- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210011
Enhancing the Resilience of Parents by Understanding Their Perceptions, Behaviour, Attitudes, and Experiences Related to Cancer and Its Treatment of Their Child
Study Overview
Status
Conditions
Detailed Description
Advances in diagnostic techniques and cancer treatments have yielded remarkable increases in the overall survival rates of children with cancer. Inevitably, however, cancer and its treatments may also have long-term effects on the physical and psychological well-being of children with cancer,
Previous studies revealed that parents play a pivotal role in encouraging their child with cancer to engage in healthy behaviours. It was shown that Chinese parental psychological behaviour and control may influence the psychological well-being of their children. Therefore, a thorough understanding the needs and concerns of Chinese parents, including their perceptions, behaviour, attitudes, and experiences related to the illness of their child is essential to facilitate them to empower their child to fight at every step of the long and difficult cancer journey.
On the other hand, the diagnosis of cancer not only undermines children themselves in physical and psychological, but also it brings overwhelming psychological distress for these children's parents. An increasing number of studies have examined patients' resilience in adaptation to cancer. Assessing resilience in parents of children with cancer is crucial for a thorough understanding of their responses to stress and adversity, which is an essential prerequisite for the design of an appropriate psychological intervention to enhance their resilience and foster the development of their coping mechanisms and positive psychological well-being. Nevertheless, the resilience levels and its influencing factors among parents of children with cancer in Hong Kong have never been studied.. Further qualitative and quantitative analyses are necessary to thoroughly explore the relationships between resilience and its influencing factors from a culturally specific perspective, with the goal of developing interventions to promote resilience that are applicable to the Hong Kong Chinese population.
A sequential mixed methods design will be used with a quantitative study (Phase I) will be first conducted and followed by a qualitative study (Phase II). The reason for that the quantitative findings will provide a general understanding of the psychosocial well-being and quality of life of Hong Kong Chinese parents of children with cancer. The qualitative findings and the analysis will help to explain the quantitative findings by exploring the perceptions, behaviour, attitudes, and experiences related to cancer and its treatment of their child.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- the primary caregiver, either father or mother,
- ability to speak Cantonese and read Chinese-language materials,
- having a child aged 0-16 years and diagnosed with cancer at some time in the previous month and currently undergoing active treatment
Exclusion Criteria:
- Parents with chronic illness and cognitive or learning disorders
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Connor-Davidson resilience scale
Time Frame: baseline
|
Connor-Davidson resilience scale (CD-RISC) will be used to measure the resilience level of parents having children with cancer.
It contains a total of 25 items, which can be divided into 3 subcategories: (1) tenacity, (2) strength, and (3) optimism.The total possible scores of the scale range from 0 to 100, with a higher score indicating greater resilience.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The EuroQoL 5-Dimension 5-level
Time Frame: baseline
|
The EuroQoL 5-Dimension 5-level (EQ-5D-5L) will be used to measure parents' quality of life.Each health state can potentially be assigned a summary index score based on societal preference weights for the health state.
Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
|
baseline
|
The Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: baseline
|
The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items, which was originally designed to measure depressive symptoms in general population surveys.Subjects are asked to rate the frequency of each symptom during the past week on a four-point Likert scale representing 'rarely (less than 1 day)', 'some (1-2 days)', 'occasionally (3-4 days)' and 'most (5-7 days)', which are scored from 0 to 3, with total possible scores ranging from 0 to 60. Higher scores indicate a greater risk of depression.
|
baseline
|
The Chinese version of the State Anxiety Scale for Adults (C-SAS-A)
Time Frame: baseline
|
The state anxiety level of parents will be measured by using the The Chinese version of the State Anxiety Scale for Adults (C-SAS-A).
The scale consists of 20 items, which are scored from 1 to 4, with possible scores ranging from 20 to 80.
|
baseline
|
The Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: baseline
|
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree) measuring three sources of support, namely, Family, Friends, and Significant Other.
|
baseline
|
Parents' perceptions, behaviour, attitudes, and experiences related to the cancer and its treatment of their child
Time Frame: baseline
|
Parents will be asked their perceptions, behaviour, attitudes, and experiences related to the cancer and its treatment of their child in the semi-structured interview.
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Parental Resilience
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Parents of Children With Cancer
-
The University of Hong KongCompletedParents of Children With CancerHong Kong
-
The University of Hong KongCompletedResilience of Parents Having Children With CancerHong Kong
-
Chang Gung University of Science and TechnologyChang Gung Memorial HospitalCompletedParents of Children With CancerTaiwan
-
University of UlmTerminated
-
National Cancer Institute (NCI)CompletedParents of Children With Cancer | Parents of Children With NF1 | Parents of Children With Neurofibromatosis Type IUnited States, Canada
-
University Medical Center GroningenAccare; Hanzehogeschool Groningen; GGZ Friesland; WIJ Groningen; Amaryllis LeeuwardenNot yet recruitingChildren of Parents With a Mental Illness (COPMI)
-
Canterbury Christ Church UniversityBrighton & Sussex Medical SchoolCompletedThe Well Being of Parents of Children With Food AllergiesUnited Kingdom
-
University of California, MercedCompletedParents of Children Ages 10 to 17 Years OldUnited States
-
Northwestern UniversityDepartment of Health and Human ServicesCompletedChildren | ParentsUnited States
-
Canterbury Christ Church UniversityUniversity of SurreyCompletedThe Quality of Life of Parents of Children With Food AllergyUnited Kingdom