- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03298971
The Impact of Cancer on the Physical and Psychosocial Well-being Among Childhood Osteosarcoma Survivors
September 6, 2021 updated by: The University of Hong Kong
The Impact of Cancer and Treatment-related Effects on the Physical and Psychosocial Well-being and Quality of Life Among Hong Kong Chinese Survivors of Childhood Osteosarcoma: An Exploratory Study
The aim of the study is to examine the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of childhood osteosarcoma.
Study Overview
Detailed Description
Osteosarcoma is the most common primary malignant bone tumor in children and adolescents.
The 5-year overall survival rates of childhood osteosarcoma survivors have been increasing substantially with a percentage approaching to 70%.
Regrettably, the improved survival rates may lead to long-term sequelae related to disease and treatments that can negatively affect survivors' physical and psychological well-being.
Despite numerous studies have examined the impact of cancer and treatment-related late effects on the physical and psychological aspects of osteosarcoma survivors in the foreign countries, it has not been studied specifically in Hong Kong Chinese population.
Problems arise when there is a difference in perception and recognition of psychological problems and emotional well-being between Western and Chinese culture.
Moreover, the difference in coping strategies between Chinese and Western children also affects how they react and cope with the devastating effect from cancer and its treatments.
Due to the cultural and belief differences, the findings from those studies in the foreign counties may not be applicable and transferable in Hong Kong context.
There is thus an imperative need to investigate the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of childhood osteosarcoma in order to raise awareness of the holistic wellness of osteosarcoma survivors.
Study Type
Observational
Enrollment (Anticipated)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ho Cheung William Li
- Phone Number: 39176634
- Email: william3@hku.hk
Study Contact Backup
- Name: Long Kwan Ho
- Phone Number: 39176643
- Email: longkwan@hku.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hong Kong Chinese under the age of 30 years who completed the entire course of treatment at least 5 years and were diagnosed with osteosarcoma under the age of 19 years.
Description
Inclusion Criteria:
- Hong Kong Chinese under the age of 30 years at the time of study participation;
- Diagnosed with osteosarcoma under the age of 19 years;
- Completed the entire course of treatment at least 5 years;
- Able to speak fluent Cantonese and read Chinese.
Exclusion Criteria:
- Survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Survivors of Childhood Osteosarcoma
Survivors of Childhood Osteosarcoma were invited to fill in a set of questionnaires.
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Participants were asked to respond to the questionnaires including Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)), the Chinese version of The Center for Epidemiological Studies - Depression Scale (CES-D), the Chinese version of Rosenberg self-esteem scale, and the Chinese version of the Herth Hope Index (HHI).
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Healthy Subjects
Healthy Subjects were invited to fill in a set of questionnaires.
|
Participants were asked to respond to the questionnaires including Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)), the Chinese version of The Center for Epidemiological Studies - Depression Scale (CES-D), the Chinese version of Rosenberg self-esteem scale, and the Chinese version of the Herth Hope Index (HHI).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of quality of life at baseline
Time Frame: baseline
|
The quality of life of the participants will be measured by the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)).
It consists of 28 items with a five-point response Likert scale.
There are two questions to access the overall perception of quality of life and health respectively.
The remaining 26 items were designed to assess the perception of quality of life in four particular domains including physical health, psychological well-being, social relationships and environments.
Higher scores represent higher levels of QoL.
Participants will be asked to respond to the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)) at baseline.
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of self-esteem at baseline
Time Frame: baseline
|
The self-esteem of the participants will be measured by the Chinese version of the Rosenberg Self-esteem Scale (RSES).
RSES consists of 10 items with a four-point response Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) and the total scores is ranging from 10 to 40.
Higher scores represent higher levels of self-esteem.
Participants will be asked to respond to the Chinese version of the Rosenberg Self-esteem Scale (RSES) at baseline.
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baseline
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Number of depressive symptoms at baseline
Time Frame: baseline
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The number of depressive symptoms of the participants will be measured by the Center for Epidemiological Studies - Depression Scale (CES-D).
It is able to assess the numbers of depressive symptoms due to the experience of past week.
The scale consists of 20 items with four-point Likert scale for patients to response and the total score is ranging from 0 to 60. Higher scores represent greater numbers of depressive symptoms while lower scores represent fewer numbers of depressive symptoms.
Participants will be asked to respond to the Center for Epidemiological Studies - Depression Scale (CES-D) at baseline.
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baseline
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Level of sense of hope at baseline
Time Frame: baseline
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The sense of hope of the participants will be measured by the Chinese version of Herth Hope Index (HHI).
It is a 12-item psychometric scale to measure the sense of hope.
Each item contains four-point scale ("strong disagree" = "1", "disagree" = "2", "agree" = "3", "strong agree" = "4").
The total score of the 12 items ranging from 12 to 48 and higher scores imply increasing hopefulness.
Participants will be asked to respond to the Chinese version of the Herth Hope Index (HHI) at baseline.
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baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ho Cheung William Li, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2017
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
September 27, 2017
First Submitted That Met QC Criteria
September 29, 2017
First Posted (Actual)
October 2, 2017
Study Record Updates
Last Update Posted (Actual)
September 8, 2021
Last Update Submitted That Met QC Criteria
September 6, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 17-331
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Osteosarcoma
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National Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Recurrent Neuroblastoma | Recurrent Osteosarcoma | Recurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Recurrent Childhood Soft Tissue Sarcoma | Recurrent Childhood Malignant Germ Cell Tumor | Recurrent... and other conditionsUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Recurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Recurrent Neuroblastoma | Recurrent Osteosarcoma | Recurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Recurrent Ewing Sarcoma/Peripheral... and other conditionsUnited States
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