Childhood OsteosarcomaNCT03298971
The Impact of Cancer on the Physical and Psychosocial Well-being Among Childhood Osteosarcoma Survivors
An observational study of Childhood Osteosarcoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Childhood Osteosarcoma
- What is being tested?
- Questionnaires
- How many people
- 240 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Sep 2017to 1 Dec 2022
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Ho Cheung William Li, PhD, 39176634, william3@hku.hk
Ho Cheung William Li, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Osteosarcoma
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Survivors of Childhood Osteosarcoma | Survivors of Childhood Osteosarcoma were invited to fill in a set of questionnaires. Receives: Other: Questionnaires | |
| Healthy Subjects | Healthy Subjects were invited to fill in a set of questionnaires. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of quality of life at 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.
Measured: baseline
Secondary outcomes (3)
Levels of self-esteem at 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.
Measured: baseline
Number of depressive symptoms at baseline
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.
Measured: baseline
Level of sense of hope at baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start8 Sep 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood OsteosarcomaStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298971
- Sponsor's protocol ID
- UW 17-331
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2017
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03298971
- Acronym / sponsor ID
- UW 17-331
- Conditions
- Childhood Osteosarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 2 Oct 2017 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors of Childhood Osteosarcoma | – | Other: QuestionnairesSurvivors of Childhood Osteosarcoma were invited to fill in a set of questionnaires. |
| Healthy Subjects | – | Other: QuestionnairesHealthy Subjects were invited to fill in a set of questionnaires. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment
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 |
|---|---|---|
| QuestionnairesParticipants 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). | Other | Healthy Subjects, Survivors of Childhood Osteosarcoma |
Primary outcome
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.
3 secondary outcomes
Levels of self-esteem at baseline
Time frame: baseline
Number of depressive symptoms at baseline
Time frame: baseline
Level of sense of hope at baseline
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- 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 William 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 Childhood Osteosarcoma, 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 4 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: status not confirmed, as of the sponsor's last update on 8 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Cheung William Li (39176634, william3@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of quality of life at baseline (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2021.