Validation of the Chinese Version of the Pittsburgh Sleep Quality Index in Hong Kong Childhood Cancer Survivors

NCT03858218 | Completed

• 1 other identifier: UW 18-366
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Health-Related Quality Of Life

Keywords

Psychometric properties; Sleep disturbance; Childhood cancer survivors; Quality of life,; Confirmatory factor analysis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  The outcome will be collected at the baseline.

Study Arms (2)

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.

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.

Other: questionnaires set

Interventions

questionnaires set OTHER

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)

Healthy children group; Pediatric cancer survivors group

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Survivors with identified cognitive or behavioral problem(s) in their medical records

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 34229705 DERIVED

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ho Cheung Wiliam Li

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: February 28, 2019
• Study Start: November 1, 2018
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)