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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04210011
Other study ID # Parental Resilience
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2020
Est. completion date April 30, 2022

Study information

Verified date March 2020
Source The University of Hong Kong
Contact Ho Cheung William Li, PhD
Phone 39176634
Email william3@hku.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to describe the psychosocial well-being and quality of life of Hong Kong Chinese parents of children with cancer with the aim at understanding the needs and concerns of parents, including their perceptions, behaviour, attitudes, and experiences related to cancer and its treatment of their child.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Connor-Davidson resilience scale 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 The EuroQoL 5-Dimension 5-level 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
Secondary The Center for Epidemiologic Studies Depression Scale (CES-D) 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
Secondary The Chinese version of the State Anxiety Scale for Adults (C-SAS-A) 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
Secondary The Multidimensional Scale of Perceived Social Support (MSPSS) 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
Secondary Parents' perceptions, behaviour, attitudes, and experiences related to the cancer and its treatment of their child 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
See also
  Status Clinical Trial Phase
Completed NCT01702922 - Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)
Completed NCT05654155 - The Effectiveness of Auricular Acupressure on Sleep Quality, Mood Status, and Quality of Life N/A
Completed NCT04038242 - A Resilience Promotion Program for Parents of Children With Cancer N/A