Parents of Children With CancerNCT04038242
A Resilience Promotion Program for Parents of Children With Cancer
A study testing Resilience promotion program in people with Parents of Children With Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Cancer is a leading cause of death for children. With the increasing incidence of childhood cancer, the mental health problems emerge in those parents struggle with their children's life-threatened disease. Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. 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
- What is being tested?
- Resilience promotion program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Aug 2019to 21 Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- having a child (0-19 years old) with cancer diagnosis.
- Chinese resident and able to read Chinese and speak Mandarin.
Who cannot join
- having 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
Cancer is a leading cause of death for children. With the increasing incidence of childhood cancer, the mental health problems emerge in those parents struggle with their children's life-threatened disease. Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Many studies have been conducted to screen the psychological distress for these parents and found a considerable percentage of them suffering from depressive symptoms. Poorer quality of life was also found in parents of children with cancer when compared to parents of children without cancer. Additionally, parental distress interacted with children's emotions and could have detrimental effects on children's both physical and mental health. Therefore, it is important to take measures improving the mental health for parents of children with cancer.
Although current various psychological interventions illustrated small to moderate improvements of mental health for parents of children with cancer, the total effect base on a systematic review was not statistically significant. The purpose of these interventions was predominantly to treat negative mental health problems such as depression and no recognized effective psychological interventions were available for parents of children with cancer until now. Along with the paradigm shift from problem-oriented approach to nurturing strengths in the post-modern period, instead of exclusively treating mental health problems, researchers payed more attention to positive therapy such as resilience promotion program. Resilience usually refers to the ability to adapt adverse conditions and maintain positive status. Resilience studies are mounting since the flourishing of positive psychology movement and meaningful results were gained from corresponding intervention program concentrating on resilience promotion in adolescent education, handling chronic disease and recovery of breast cancer. However, there is a lack of targeted resilience promotion program for parents of children with cancer. The results of our pilot study showed low levels of resilience in parents of children with cancer and strong associations among parental resilience, quality of life and depression. It indicates that the increase in resilience can benefit for the mental health of parents. Therefore, a resilience promotion program will be conducted to examine efficacy for parents of children with cancer.
- Conditions
- Parents of Children With Cancer
- Being tested
- Resilience promotion program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience promotion programOther
Resilience Promotion Program consists of eight sessions. Except the first orientation session and the last review session, other six sessions focus on cultivating the five internal resiliency factors (physical, behavioral, cognitive, emotional and spiritual). There are two sessions for behavioral factor, including one special to deal with the relationships between parents and children.
| Study group | Role | What they receive |
|---|---|---|
| Resilience promotion program | Experimental | Subjects in the intervention group will participate in an eight-session resilience promotion program. Receives: Other: Resilience promotion program |
| Treatment as usual | No intervention | Treatment as usual for subjects in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of resilience from baseline to 6-month follow-up between intervention and control group
The primary outcome measure is the resilience of subjects at 6-month follow-up when compare to baseline. The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.
Measured: 6-month follow-up
Secondary outcomes (14)
Levels of resilience at baseline
The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.
Measured: baseline
Change in levels of resilience from baseline to 2-month follow-up between intervention and control group
The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.
Measured: 2-month follow-up
Levels of quality of life at baseline
The Short Form of Medical Outcomes will be used to measure quality of life. The total score ranges from 0.32 for the worst health state to 1 for full health.
Measured: baseline
Change in levels of quality of life from baseline to 2-month follow-up between intervention and control group
The Short Form of Medical Outcomes will be used to measure quality of life. The total score ranges from 0.32 for the worst health state to 1 for full health.
Measured: 2-month follow-up
Change in levels of quality of life from baseline to 6-month follow-up between intervention and control group
The Short Form of Medical Outcomes will be used to measure quality of life. The total score ranges from 0.32 for the worst health state to 1 for full health.
Measured: 6-month follow-up
Levels of depression at baseline
Self-rating depression scale will be used to measure depression. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.
Measured: baseline
Change in levels of depression from baseline to 2-month follow-up between intervention and control group
Self-rating depression scale will be used to measure depression. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.
Measured: 2-month follow-up
Change in levels of depression from baseline to 6-month follow-up between intervention and control group
Self-rating depression scale will be used to measure depression. The total score ranges from 20 to 80. Higher total score indicates more serious depression status.
Measured: 6-month follow-up
Levels of anxiety at baseline
Self-rating anxiety scale will be used to measure anxiety. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.
Measured: baseline
Change in levels of anxiety from baseline to 2-month follow-up between intervention and control group
Self-rating anxiety scale will be used to measure anxiety. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.
Measured: 2-month follow-up
Change in levels of anxiety from baseline to 6-month follow-up between intervention and control group
Self-rating anxiety scale will be used to measure anxiety. The total score ranges from 25 to 100 and higher score reflects worse anxiety status.
Measured: 6-month follow-up
Levels of stress at baseline
The perceived stress scale will be used to measure stress. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.
Measured: baseline
Change in levels of stress from baseline to 2-month follow-up between intervention and control group
The perceived stress scale will be used to measure stress. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.
Measured: 2-month follow-up
Change in levels of stress from baseline to 6-month follow-up between intervention and control group
The perceived stress scale will be used to measure stress. The total score ranges from 0 to 40. Higher total score suggests more perceived stress.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start13 Aug 2019
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan Hui Luo, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038242
- Sponsor's protocol ID
- UW 19-436
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo Y, Li HCW, Cheung AT, Ho LLK, Xia W, Zhang J. Evaluating the experiences of parents of children with cancer engaging in a mobile device-based resilience training programme: a qualitative study. Support Care Cancer. 2022 Jul;30(7):6205-6214. doi: 10.1007/s00520-022-07066-7. Epub 2022 Apr 20.
PubMed 35441899Luo Y, Xia W, Cheung AT, Ho LLK, Zhang J, Xie J, Xiao P, Li HCW. Effectiveness of a Mobile Device-Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial. J Med Internet Res. 2021 Nov 29;23(11):e27639. doi: 10.2196/27639.
PubMed 34847060
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Resilience Promotion Program for Parents of Children With Cancer
- ClinicalTrials.gov ID
- NCT04038242
- Acronym / sponsor ID
- UW 19-436
- Conditions
- Parents of Children With Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 30 Jul 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.
Cancer is a leading cause of death for children. With the increasing incidence of childhood cancer, the mental health problems emerge in those parents struggle with their children's life-threatened disease. Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Many studies have been conducted to screen the psychological distress for these parents and found a considerable percentage of them suffering from depressive symptoms. Poorer quality of life was also found in parents of children with cancer when compared to parents of children without cancer. Additionally, parental distress interacted with children's emotions and could have detrimental effects on children's both physical and mental health. Therefore, it is important to take measures improving the mental health for parents of children with cancer.
Although current various psychological interventions illustrated small to moderate improvements of mental health for parents of children with cancer, the total effect base on a systematic review was not statistically significant. The purpose of these interventions was predominantly to treat negative mental health problems such as depression and no recognized effective psychological interventions were available for parents of children with cancer until now. Along with the paradigm shift from problem-oriented approach to nurturing strengths in the post-modern period, instead of exclusively treating mental health problems, researchers payed more attention to positive therapy such as resilience promotion program. Resilience usually refers to the ability to adapt adverse conditions and maintain positive status. Resilience studies are mounting since the flourishing of positive psychology movement and meaningful results were gained from corresponding intervention program concentrating on resilience promotion in adolescent education, handling chronic disease and recovery of breast cancer. However, there is a lack of targeted resilience promotion program for parents of children with cancer. The results of our pilot study showed low levels of resilience in parents of children with cancer and strong associations among parental resilience, quality of life and depression. It indicates that the increase in resilience can benefit for the mental health of parents. Therefore, a resilience promotion program will be conducted to examine efficacy for parents of children with cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience promotion program | Experimental | Other: Resilience promotion programSubjects in the intervention group will participate in an eight-session resilience promotion program. |
| Treatment as usual | No intervention | –Treatment as usual for subjects in the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- having a child (0-19 years old) with cancer diagnosis.
- Chinese resident and able to read Chinese and speak Mandarin.
Key exclusion criteria (2 listed)
- having 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 |
|---|---|---|
| Resilience promotion programResilience Promotion Program consists of eight sessions. Except the first orientation session and the last review session, other six sessions focus on cultivating the five internal resiliency factors (physical, behavioral, cognitive, emotional and spiritual). There are two sessions for behavioral factor, including one special to deal with the relationships between parents and children. | Other | Resilience promotion program |
Primary outcome
Change in levels of resilience from baseline to 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
The primary outcome measure is the resilience of subjects at 6-month follow-up when compare to baseline. The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.
14 secondary outcomes
Levels of resilience at baseline
Time frame: baseline
Change in levels of resilience from baseline to 2-month follow-up between intervention and control group
Time frame: 2-month follow-up
Levels of quality of life at baseline
Time frame: baseline
Change in levels of quality of life from baseline to 2-month follow-up between intervention and control group
Time frame: 2-month follow-up
Change in levels of quality of life from baseline to 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
Levels of depression at baseline
Time frame: baseline
Change in levels of depression from baseline to 2-month follow-up between intervention and control group
Time frame: 2-month follow-up
Change in levels of depression from baseline to 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
Levels of anxiety at baseline
Time frame: baseline
Change in levels of anxiety from baseline to 2-month follow-up between intervention and control group
Time frame: 2-month follow-up
Change in levels of anxiety from baseline to 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
Levels of stress at baseline
Time frame: baseline
Change in levels of stress from baseline to 2-month follow-up between intervention and control group
Time frame: 2-month follow-up
Change in levels of stress from baseline to 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
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 19 Oct 2020.
- Derived from this study: PubMed 35441899Luo Y, Li HCW, Cheung AT, Ho LLK, Xia W, Zhang J. Evaluating the experiences of parents of children with cancer engaging in a mobile device-based resilience training programme: a qualitative study. Support Care Cancer. 2022 Jul;30(7):6205-6214. doi: 10.1007/s00520-022-07066-7. Epub 2022 Apr 20.
- Derived from this study: PubMed 34847060Luo Y, Xia W, Cheung AT, Ho LLK, Zhang J, Xie J, Xiao P, Li HCW. Effectiveness of a Mobile Device-Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial. J Med Internet Res. 2021 Nov 29;23(11):e27639. doi: 10.2196/27639.
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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.
Yuan Hui Luo, 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?
A study testing Resilience promotion program in people with 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 2 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 19 Oct 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?
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?
Change in levels of resilience from baseline to 6-month follow-up between intervention and control group (time frame: 6-month follow-up). 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 NCT04038242, 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 19 Oct 2020.