Health-Related Quality Of LifeNCT03858218
Validation of the Chinese Version of the Pittsburgh Sleep Quality Index in Hong Kong Childhood Cancer Survivors
An observational study of Health-Related Quality Of Life, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Cancer is one of the major causes of death in pediatric population. In Hong Kong, childhood cancer remains a significant concern in healthcare system because of its damaging impacts on adolescent's physical and psychological functions throughout their lifespan. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Health-Related Quality Of Life
- What is being tested?
- questionnaires set
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2018to 16 Jan 2020
- 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: To assess the known-group validity, 50 pediatric cancer patients and 50 healthy children will be recruited in a pediatric oncology ward and a community center, respectively. The inclusion and exclusion for the pediatric cancer patients and healthy children will be the same as those for the childhood cancer survivors.
Who may be able to join
- Hong Kong Chinese childhood cancer survivors who have completed cancer treatment for at least six months.
- Be aged 9 - 17 years.
- Be able to communicate in Cantonese and read Chinese.
Who cannot join
- Survivors with identified cognitive or behavioral problem(s) in their medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of the Chinese Version of the Pittsburgh Sleep Quality Index in Hong Kong Chinese Childhood Cancer Survivors
Cancer is one of the major causes of death in pediatric population. In Hong Kong, childhood cancer remains a significant concern in healthcare system because of its damaging impacts on adolescent's physical and psychological functions throughout their lifespan. Particularly, adolescents surviving cancer still have to bear the health burden of numerous sequelae, even their treatment is completed for months and even years.
One of the most prevalent symptoms reported by patients surviving cancer is sleep disturbance. The causes of sleep disturbance are multifactorial. However, it can largely be attributed to disruption of circadian rhythm by prolonged use of medications and long-term hospitalization. Experiencing sleep disturbance can be devastating for survivors of cancer and precipitates inflammation and oxidative stress, which are known to be a contributing factor of neurocognitive impairment. Sleep disturbance can also lead to fatigue, which in turn limits patients' capacity in engaging in daily activities and even results in depression, severely compromising patients' quality of life in the long run. Having a reliable and valid instrument that can precisely assess the problem of sleep disturbance of cancer survivors is therefore crucial for the development and evaluation of the intervention.
The Pittsburgh Sleep Quality Index (PSQI) is the most commonly and frequently used instrument to assess sleep disturbance. Because of differences in culture and language, some concepts or items in the English version may be inappropriate for adolescents living in Hong Kong. Moreover, the psychometrics of the PSQI has only been established in adolescents undergoing active treatment for cancer, when they experienced the most severe problem. It is therefore unclear whether the PSQI can also be used to assess sleep disturbance of adolescents who have completed cancer treatment. This lack of validated instruments precludes us from understanding the severity of the problem. Also, it hinders the development of appropriate interventions that promote sleep quality. This study aims to bridge the gap in existing literature by translating the PSQI from English into Chinese, and examining the psychometrics of the translated PSQI in Hong Kong Chinese childhood cancer survivors.
Read the detailed description
Cancer is one of the major causes of death in pediatric population. In Hong Kong, 46 patients aged 0 - 19 died from cancer in 2016. Childhood cancer is not common. According to Hong Kong Cancer Registry, there are approximately 190 newly diagnosed cases of childhood cancer each year. Despite this figure is not as high as that in adults, childhood cancer remains a significant concern in healthcare system because of its damaging impacts on children's physical and psychological functions throughout their lifespan. Particularly, children surviving cancer still have to pay a high price for numerous sequelae, notwithstanding their treatment is completed after months and even years.
One of the most prevalent symptoms reported by patients surviving cancer is sleep disturbance. A systematic review indicates 25 - 59 % adults reporting sleep disturbance after their treatment for cancer. A retrospective cohort study in the West also pointed out that 16.7% of childhood cancer survivors complained of disrupted sleep. The causes of sleep disturbance are multifactorial. However, it can largely be attributed to disruption of circadian rhythm by prolonged use of medications and longterm hospitalization. In fact, experiencing sleep disturbance can be devastating for survivors of cancer. Previous literature indicates that sleep disturbance precipitates inflammation and oxidative stress, which are known to be a contributing factor of neurocognitive impairment. Sleep disturbance can also lead to fatigue, which in turn limits patients' capacity in engaging in daily activities and even results in depression, severely compromising patients' quality of life in the long run. In this regard, healthcare professionals, particularly oncology nurses should bear unshrinkable responsibility to intervene this symptom with appropriate interventions, with an aim of improving the survivors' sleep quality and quality of life. Having a reliable and valid instrument that can precisely assess the problem of sleep disturbance of cancer survivors is therefore crucial for the development and evaluation of the intervention.
The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used instrument to assess sleep disturbance. Although this instrument was originally developed to collect subjective information about sleep habits of psychiatric patients, it has been translated into different languages, and has been extensively applied in studies on adult cancer survivors. The results of these studies generally support this instrument to be reliable and valid in assessing sleep disturbance for this group of population. Despite the growing popularity of using this instrument in adults, no studies has so far been conducted to validate the PSQI in the pediatric population, thus limiting its usefulness for children and adolescents. In fact, a comprehensive review of the literature indicated that no validated instrument is currently available for assessing sleep disturbance of childhood cancer survivors, especially in the Hong Kong Chinese context. This lack of validated instruments precludes us from understanding the severity of the problem. Also, it hinders the development of appropriate interventions that promote sleep quality.
- Conditions
- Health-Related Quality Of Life
- Being tested
- questionnaires set
- Keywords
- Psychometric properties, Sleep disturbance, Childhood cancer survivors, Quality of life,, Confirmatory factor analysis
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires setOther
questionnaires set: The Chinese version of the Pittsburgh Sleep Quality Index (PSQI)+The Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC)+ The Chinese version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0)
| Study group | Role | What they receive |
|---|---|---|
| Pediatric cancer survivors group | Childhood cancer survivors refers to those who have completed cancer treatment for at least six months, the pediatric cancer survivors must be aged 9 - 17 years, and able to communicate in Cantonese and read Chinese.This group will be required to fill in the questionnaires set. Receives: Other: questionnaires set | |
| Healthy children group | Healthy children must be aged 9 - 17 years, and able to communicate in Cantonese and read Chinese. This group will be required to fill in the questionnaires set. Receives: Other: questionnaires set |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
The principal investigator has obtained the approval for using the Chinese version of the PSQI in this study.
Measured: The outcome will be collected at the baseline.
The score of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
The CES-DC is used to measure the severity of depressive symptoms in children and adolescents under 18. The respondents are invited to complete the questionnaire which consists of 20 self-report items. Each of the items is rated on a 4-point Likert scale that indicates the frequency of symptoms in the past week. A score of 0 indicates "not at all"; a score of 1 indicates "a little", a score of 2 indicates "some"; and a score of 3 indicates "a lot". Four items are reverse-scored. The sum of the 20 items is then calculated to yield a total score ranging from 0-60. A score under 15 indicates mild or no depression symptoms, while a score of 15 or higher indicates a risk for depression in children and adolescents.
The Chinese version of the CES-DC has been released to the public.
Measured: The outcome will be collected at the baseline.
The score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales
The PedsQL is a 23-item scale that measures four dimensions of health: physical functioning, emotional functioning, social functioning, and school functioning. All items are rated on a 5-point Likert scale from 0 (Never) to 4 (Almost Always). The scoring involves a 2-step process. First, the items are reverse-scored and transformed to a 0-100 scale, i.e. 0=100, 1=75, 2=50, 3=25, 4=0. The total score is then generated by computing the mean of all item scores (i.e. the sum of all items over the number of items answered). A higher score means a better pediatric quality of life.
The principal investigator has obtained the approval for using the Chinese version of the PedsQL in this study.
Measured: The outcome will be collected at the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Nov 2018
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health-Related Quality Of LifeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung Wiliam Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858218
- Sponsor's protocol ID
- UW 18-366
- Status last verified
- Mar 2020
- First submitted
- 6 Nov 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho KY, Lam KKW, Xia W, Chung JOK, Cheung AT, Ho LLK, Chiu SY, Chan GCF, Li WHC. Psychometric properties of the Chinese version of the Pittsburgh Sleep Quality Index (PSQI) among Hong Kong Chinese childhood cancer survivors. Health Qual Life Outcomes. 2021 Jul 6;19(1):176. doi: 10.1186/s12955-021-01803-y.
PubMed 34229705
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Chinese Version of the Pittsburgh Sleep Quality Index in Hong Kong Chinese Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT03858218
- Acronym / sponsor ID
- UW 18-366
- Conditions
- Health-Related Quality Of Life
- Keywords
- Psychometric properties, Sleep disturbance, Childhood cancer survivors, Quality of life,, Confirmatory factor analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 28 Feb 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 one of the major causes of death in pediatric population. In Hong Kong, childhood cancer remains a significant concern in healthcare system because of its damaging impacts on adolescent's physical and psychological functions throughout their lifespan. Particularly, adolescents surviving cancer still have to bear the health burden of numerous sequelae, even their treatment is completed for months and even years.
One of the most prevalent symptoms reported by patients surviving cancer is sleep disturbance. The causes of sleep disturbance are multifactorial. However, it can largely be attributed to disruption of circadian rhythm by prolonged use of medications and long-term hospitalization. Experiencing sleep disturbance can be devastating for survivors of cancer and precipitates inflammation and oxidative stress, which are known to be a contributing factor of neurocognitive impairment. Sleep disturbance can also lead to fatigue, which in turn limits patients' capacity in engaging in daily activities and even results in depression, severely compromising patients' quality of life in the long run. Having a reliable and valid instrument that can precisely assess the problem of sleep disturbance of cancer survivors is therefore crucial for the development and evaluation of the intervention.
The Pittsburgh Sleep Quality Index (PSQI) is the most commonly and frequently used instrument to assess sleep disturbance. Because of differences in culture and language, some concepts or items in the English version may be inappropriate for adolescents living in Hong Kong. Moreover, the psychometrics of the PSQI has only been established in adolescents undergoing active treatment for cancer, when they experienced the most severe problem. It is therefore unclear whether the PSQI can also be used to assess sleep disturbance of adolescents who have completed cancer treatment. This lack of validated instruments precludes us from understanding the severity of the problem. Also, it hinders the development of appropriate interventions that promote sleep quality. This study aims to bridge the gap in existing literature by translating the PSQI from English into Chinese, and examining the psychometrics of the translated PSQI in Hong Kong Chinese childhood cancer survivors.
Detailed description
Cancer is one of the major causes of death in pediatric population. In Hong Kong, 46 patients aged 0 - 19 died from cancer in 2016. Childhood cancer is not common. According to Hong Kong Cancer Registry, there are approximately 190 newly diagnosed cases of childhood cancer each year. Despite this figure is not as high as that in adults, childhood cancer remains a significant concern in healthcare system because of its damaging impacts on children's physical and psychological functions throughout their lifespan. Particularly, children surviving cancer still have to pay a high price for numerous sequelae, notwithstanding their treatment is completed after months and even years.
One of the most prevalent symptoms reported by patients surviving cancer is sleep disturbance. A systematic review indicates 25 - 59 % adults reporting sleep disturbance after their treatment for cancer. A retrospective cohort study in the West also pointed out that 16.7% of childhood cancer survivors complained of disrupted sleep. The causes of sleep disturbance are multifactorial. However, it can largely be attributed to disruption of circadian rhythm by prolonged use of medications and longterm hospitalization. In fact, experiencing sleep disturbance can be devastating for survivors of cancer. Previous literature indicates that sleep disturbance precipitates inflammation and oxidative stress, which are known to be a contributing factor of neurocognitive impairment. Sleep disturbance can also lead to fatigue, which in turn limits patients' capacity in engaging in daily activities and even results in depression, severely compromising patients' quality of life in the long run. In this regard, healthcare professionals, particularly oncology nurses should bear unshrinkable responsibility to intervene this symptom with appropriate interventions, with an aim of improving the survivors' sleep quality and quality of life. Having a reliable and valid instrument that can precisely assess the problem of sleep disturbance of cancer survivors is therefore crucial for the development and evaluation of the intervention.
The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used instrument to assess sleep disturbance. Although this instrument was originally developed to collect subjective information about sleep habits of psychiatric patients, it has been translated into different languages, and has been extensively applied in studies on adult cancer survivors. The results of these studies generally support this instrument to be reliable and valid in assessing sleep disturbance for this group of population. Despite the growing popularity of using this instrument in adults, no studies has so far been conducted to validate the PSQI in the pediatric population, thus limiting its usefulness for children and adolescents. In fact, a comprehensive review of the literature indicated that no validated instrument is currently available for assessing sleep disturbance of childhood cancer survivors, especially in the Hong Kong Chinese context. This lack of validated instruments precludes us from understanding the severity of the problem. Also, it hinders the development of appropriate interventions that promote sleep quality.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric cancer survivors group | – | Other: questionnaires setChildhood cancer survivors refers to those who have completed cancer treatment for at least six months, the pediatric cancer survivors must be aged 9 - 17 years, and able to communicate in Cantonese and read Chinese.This group will be required to fill in the questionnaires set. |
| Healthy children group | – | Other: questionnaires setHealthy children must be aged 9 - 17 years, and able to communicate in Cantonese and read Chinese. This group will be required to fill in the questionnaires set. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- To assess the known-group validity, 50 pediatric cancer patients and 50 healthy children will be recruited in a pediatric oncology ward and a community center, respectively. The inclusion and exclusion for the pediatric cancer patients and healthy children will be the same as those for the childhood cancer survivors.
Key inclusion criteria (3 listed)
- Hong Kong Chinese childhood cancer survivors who have completed cancer treatment for at least six months.
- Be aged 9 - 17 years.
- Be able to communicate in Cantonese and read Chinese.
Key exclusion criteria (1 listed)
- Survivors with identified cognitive or behavioral problem(s) in their medical records
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 |
|---|---|---|
| questionnaires setquestionnaires set: The Chinese version of the Pittsburgh Sleep Quality Index (PSQI)+The Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC)+ The Chinese version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0) | Other | Healthy children group, Pediatric cancer survivors group |
Primary outcome
The score of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: The outcome will be collected at the baseline.
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality). The principal investigator has obtained the approval for using the Chinese version of the PSQI in this study.
The score of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time frame: The outcome will be collected at the baseline.
The CES-DC is used to measure the severity of depressive symptoms in children and adolescents under 18. The respondents are invited to complete the questionnaire which consists of 20 self-report items. Each of the items is rated on a 4-point Likert scale that indicates the frequency of symptoms in the past week. A score of 0 indicates "not at all"; a score of 1 indicates "a little", a score of 2 indicates "some"; and a score of 3 indicates "a lot". Four items are reverse-scored. The sum of the 20 items is then calculated to yield a total score ranging from 0-60. A score under 15 indicates mild or no depression symptoms, while a score of 15 or higher indicates a risk for depression in children and adolescents. The Chinese version of the CES-DC has been released to the public.
The score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales
Time frame: The outcome will be collected at the baseline.
The PedsQL is a 23-item scale that measures four dimensions of health: physical functioning, emotional functioning, social functioning, and school functioning. All items are rated on a 5-point Likert scale from 0 (Never) to 4 (Almost Always). The scoring involves a 2-step process. First, the items are reverse-scored and transformed to a 0-100 scale, i.e. 0=100, 1=75, 2=50, 3=25, 4=0. The total score is then generated by computing the mean of all item scores (i.e. the sum of all items over the number of items answered). A higher score means a better pediatric quality of life. The principal investigator has obtained the approval for using the Chinese version of the PedsQL in this study.
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 Mar 2020.
- Derived from this study: PubMed 34229705Ho KY, Lam KKW, Xia W, Chung JOK, Cheung AT, Ho LLK, Chiu SY, Chan GCF, Li WHC. Psychometric properties of the Chinese version of the Pittsburgh Sleep Quality Index (PSQI) among Hong Kong Chinese childhood cancer survivors. Health Qual Life Outcomes. 2021 Jul 6;19(1):176. doi: 10.1186/s12955-021-01803-y.
- Individual participant dataSharing planned: No
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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 Wiliam Li 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 Health-Related Quality Of Life, 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: finished, as of the sponsor's last update on 30 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?
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?
The score of the Pittsburgh Sleep Quality Index (PSQI) (time frame: The outcome will be collected at the baseline.). The study lists 3 primary outcomes in all. 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 NCT03858218, which also lists 1 linked publication.
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 Mar 2020.