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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ho Cheung William Li, PhD contact

39176634

william3@hku.hk

Hong Kong1 site, 1 recruiting

  • The University of Hong Kong

    Hong Kong

    Ho Cheung William Li, PhD, 39176634, william3@hku.hk

    Ho Cheung William Li, PhD

    Recruiting

Other trials in Hong Kong

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.

Keywords
Pediatric oncology, Parental resilience

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted24 Dec 2019
  2. Study start2 Jan 2020
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT04210011.

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.

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