Parents of Children With CancerNCT04210011
Enhancing the Resilience of Parents by Understanding Their Perceptions, Behaviour, Attitudes, and Experiences Related to Cancer and Its Treatment of Their Child
An observational study of Parents of Children With Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parents of Children With Cancer
- How many people
- 114 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jan 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hong Kong Chinese parents of children with cancer admitted to Hong Kong Children's Hospital are eligible. Study inclusion criteria for parents are as follows: (1) the primary caregiver, either father or mother, (2) ability to speak Cantonese and read Chinese-language materials, (3) having a child aged 0-16 years and diagnosed with cancer at some time in the previous month and currently undergoing active treatment. Parents with chronic illness and cognitive or learning disorders will be excluded.
Who may be able to join
- 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
Who cannot join
- Parents with chronic illness and cognitive or learning disorders
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Ho Cheung William Li, PhD, 39176634, william3@hku.hk
Ho Cheung William Li, PhD
About this study
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.
Read the 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.
- Conditions
- Parents of Children With Cancer
- Keywords
- Pediatric oncology, Parental resilience
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (5)
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).
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start2 Jan 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parents of Children With CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210011
- Sponsor's protocol ID
- Parental Resilience
- Status last verified
- Mar 2020
- First submitted
- 20 Dec 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Resilience of Parents by Understanding Their Perceptions, Behaviour, Attitudes, and Experiences Related to Cancer and Its Treatment of Their Child
- ClinicalTrials.gov ID
- NCT04210011
- Acronym / sponsor ID
- Parental Resilience
- Conditions
- Parents of Children With Cancer
- Keywords
- Pediatric oncology, Parental resilience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hong Kong Chinese parents of children with cancer admitted to Hong Kong Children's Hospital are eligible. Study inclusion criteria for parents are as follows: (1) the primary caregiver, either father or mother, (2) ability to speak Cantonese and read Chinese-language materials, (3) having a child aged 0-16 years and diagnosed with cancer at some time in the previous month and currently undergoing active treatment. Parents with chronic illness and cognitive or learning disorders will be excluded.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Parents with chronic illness and cognitive or learning disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
The EuroQoL 5-Dimension 5-level
Time frame: baseline
The Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: baseline
The Chinese version of the State Anxiety Scale for Adults (C-SAS-A)
Time frame: baseline
The Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: baseline
Parents' perceptions, behaviour, attitudes, and experiences related to the cancer and its treatment of their child
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Cheung William Li, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parents of Children With Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Cheung William Li, PhD (39176634, william3@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connor-Davidson resilience scale (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.