Resilience of Parents Having Children With CancerNCT03631485
Exploring the Mental Health of Parents Having Children With Cancer
An observational study of Resilience of Parents Having Children With Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Poor quality of life and mental health problems such as depression and anxiety were found in this population. The psychological status of them is still waited to be improved. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Resilience of Parents Having Children With Cancer
- What is being tested?
- Exposure_having children with cancer
- How many people
- 181 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Aug 2018to 27 Nov 2018
- 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: Parents having children with cancer who are treated at a tertiary hospital in Mainland China between September 2018 and December 2018 will be recruited.
Who may be able to join
- have a child (0-19 years old) with cancer diagnosis. Chinese resident and can read Chinese and speak Mandarin.
Who cannot join
- have physical impairment or cognitive and learning problems identified from family history of medical records.
- attending other researches.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of Resilience in Parents of Children With Cancer
Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Poor quality of life and mental health problems such as depression and anxiety were found in this population. The psychological status of them is still waited to be improved. As a dominant term in positive psychology, resilience is commonly regarded as the ability to move forward or keep normal under adversity. It was proved to be associated with psychological outcomes in adolescents and chronic illness patients, enhanced resilience usually along with improved mental health, while little evidence was available in the parents of children with cancer.
A cross-sectional study will be conducted to explore the level of resilience and psychological outcomes such as quality of life, depression, anxiety and well-being in parents of children with cancer using questionnaires. Such results will be compared with normal population to help evaluate the psychological status of those parents. The relationship between resilience and these psychological outcomes will also be examined. Lower resilience and higher resilience of the parents will be determined by the lowest and highest quartile of The Connor-Davidson Resilience Scale (CD-RISC) scores. Subsequently, a qualitative study will be conducted to explore the experience of those parents with lower resilience and higher resilience.
It is anticipated that risk parents of children with cancer could be identified from the inferior outcomes of resilience and psychological outcomes. Both the results of cross-sectional study and qualitative study will guide the development of interventions designed to enhance resilience and promote positive psychological outcomes among targeted parents of children with cancer under risk.
- Being tested
- Exposure_having children with cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure_having children with cancerOther
No intervention. The exposure is having children with cancer.
| Study group | Role | What they receive |
|---|---|---|
| parents having children with cancer | No intervention. Receives: Other: Exposure_having children with cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience measurement by using the Connor-Davidson resilience scale.
Resilience of parents having children with cancer will be measured. The total score ranges from 0-100 and higher score reflecting higher level of resilience.
Measured: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Secondary outcomes (4)
Quality of life measurement by using the Short Form 6D (SF-6D).
Quality of life of parents having children with cancer will be measured. The total score ranges from 0.32 for the worst health state to 1 for full health.
Measured: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Depression measurement by using self-rating depression scale.
Depression of parents having children with cancer will be measured. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.
Measured: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Anxiety measurement by using self-rating anxiety scale.
Anxiety of parents having children with cancer will be measured. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.
Measured: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Stress measurement by using perceived stress scale.
Stress of parents having children with cancer will be measured. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.
Measured: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start27 Aug 2018
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resilience of Parents Having 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631485
- Sponsor's protocol ID
- UW 18-371
- Status last verified
- May 2019
- First submitted
- 7 Aug 2018
- Last updated
- 30 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo Y, Li HCW, Xia W, Cheung AT, Ho LLK, Chung JOK. The Lived Experience of Resilience in Parents of Children With Cancer: A Phenomenological Study. Front Pediatr. 2022 May 30;10:871435. doi: 10.3389/fped.2022.871435. eCollection 2022.
PubMed 35707743Luo YH, Li WHC, Cheung AT, Ho LLK, Xia W, He XL, Zhang JP, Chung JOK. Relationships between resilience and quality of life in parents of children with cancer. J Health Psychol. 2022 Apr;27(5):1048-1056. doi: 10.1177/1359105321990806. Epub 2021 Jan 31.
PubMed 33522296
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Resilience in Parents of Children With Cancer
- ClinicalTrials.gov ID
- NCT03631485
- Acronym / sponsor ID
- UW 18-371
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 15 Aug 2018 (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.
Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Poor quality of life and mental health problems such as depression and anxiety were found in this population. The psychological status of them is still waited to be improved. As a dominant term in positive psychology, resilience is commonly regarded as the ability to move forward or keep normal under adversity. It was proved to be associated with psychological outcomes in adolescents and chronic illness patients, enhanced resilience usually along with improved mental health, while little evidence was available in the parents of children with cancer.
A cross-sectional study will be conducted to explore the level of resilience and psychological outcomes such as quality of life, depression, anxiety and well-being in parents of children with cancer using questionnaires. Such results will be compared with normal population to help evaluate the psychological status of those parents. The relationship between resilience and these psychological outcomes will also be examined. Lower resilience and higher resilience of the parents will be determined by the lowest and highest quartile of The Connor-Davidson Resilience Scale (CD-RISC) scores. Subsequently, a qualitative study will be conducted to explore the experience of those parents with lower resilience and higher resilience.
It is anticipated that risk parents of children with cancer could be identified from the inferior outcomes of resilience and psychological outcomes. Both the results of cross-sectional study and qualitative study will guide the development of interventions designed to enhance resilience and promote positive psychological outcomes among targeted parents of children with cancer under risk.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parents having children with cancer | – | Other: Exposure_having children with cancerNo intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents having children with cancer who are treated at a tertiary hospital in Mainland China between September 2018 and December 2018 will be recruited.
Key inclusion criteria (1 listed)
- have a child (0-19 years old) with cancer diagnosis. Chinese resident and can read Chinese and speak Mandarin.
Key exclusion criteria (2 listed)
- have physical impairment or cognitive and learning problems identified from family history of medical records.
- attending other researches.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure_having children with cancerNo intervention. The exposure is having children with cancer. | Other | parents having children with cancer |
Primary outcome
Resilience measurement by using the Connor-Davidson resilience scale.
Time frame: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Resilience of parents having children with cancer will be measured. The total score ranges from 0-100 and higher score reflecting higher level of resilience.
4 secondary outcomes
Quality of life measurement by using the Short Form 6D (SF-6D).
Time frame: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Depression measurement by using self-rating depression scale.
Time frame: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Anxiety measurement by using self-rating anxiety scale.
Time frame: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Stress measurement by using perceived stress scale.
Time frame: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Derived from this study: PubMed 35707743Luo Y, Li HCW, Xia W, Cheung AT, Ho LLK, Chung JOK. The Lived Experience of Resilience in Parents of Children With Cancer: A Phenomenological Study. Front Pediatr. 2022 May 30;10:871435. doi: 10.3389/fped.2022.871435. eCollection 2022.
- Derived from this study: PubMed 33522296Luo YH, Li WHC, Cheung AT, Ho LLK, Xia W, He XL, Zhang JP, Chung JOK. Relationships between resilience and quality of life in parents of children with cancer. J Health Psychol. 2022 Apr;27(5):1048-1056. doi: 10.1177/1359105321990806. Epub 2021 Jan 31.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Resilience of Parents Having 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience measurement by using the Connor-Davidson resilience scale. (time frame: A cross-sectional study will be conducted during September 2018 and January 2019. The measurement will be taken once for each participant.). 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 NCT03631485, which also lists 2 linked publications.
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 30 May 2019.