Childhood Solid TumorNCT03430752
Comparing the Impact of Cancer on Quality of Life Between Survivors of Childhood Solid Tumors and Leukemia
An observational study of Childhood Solid Tumor, 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 solid tumors. Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Childhood Solid Tumor
- What is being tested?
- questionnaires
- How many people
- 135 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Sep 2017to 31 Aug 2018
- 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 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Hong Kong Chinese under the age of 19 years who completed the entire course of treatment at least 6 months and were diagnosed with childhood solid tumors or leukemia under the age of 19 years.
Who may be able to join
- (1) Hong Kong Chinese under the age of 30 years at the time of study participation;
- (2) diagnosed with solid tumors or hematological malignancies under the age of 19 years;
- (3) completed the entire course of treatment for at least 6 months;
- (4) 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 will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Impact of Cancer and Treatment-related Effects on the Psychological Well-Being and Quality of Life Between Survivors of Childhood Solid Tumors and Leukemia
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 solid tumors.
Read the detailed description
In general, cancer can be divided into two main categories: blood cancer and solid tumors. Leukemia refer to the cancers in blood while solid tumors refer to the cancers which involve the formation of an abnormal mass without any liquid or cysts. Patients suffer from leukemia are usually have better prognosis which result in better psychological well-being when compared with those suffer from solid tumors (Rodin et al., 2010). The development of solid tumors in children is different from that in adult. Some of the solid tumors such as osteosarcoma, neuroblastoma, rhabdomyosarcoma, Wilms' tumor and retinoblastoma are exclusively found in children. Other types of solid tumors such as brain tumor can also be found in children.
Yet, most of recent studies in Hong Kong have focused in general childhood cancer survivors or their family members but no study has been conducted to focus on the physical and psychological well-being of survivors of childhood solid tumors (Li, Lopez, Chung, Ho, \& Chiu, 2013; Wills, 2009). Therefore, the quality of life and psychological well-being of solid tumors survivors are always be overestimated. The actual psychological needs of solid tumors survivors may be overlooked. 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 solid tumors.
- Conditions
- Childhood Solid Tumor
- 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 the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Chinese version of Rosenberg self-esteem scale, the Chinese version of the Herth Hope Index (HHI) and the Chinese version of Resilience Scale for Children (RS10).
| Study group | Role | What they receive |
|---|---|---|
| Survivors of Childhood Solid Tumors | Survivors of Childhood Solid Tumors were invited to fill in a set of questionnaires. Receives: Other: questionnaires | |
| Survivors of Childhood Leukemia | Survivors of Childhood Leukemia 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.
Quality of Life at baseline
The Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) consists of 23 items which are designed to measure the quality of life in four particular domains including physical ability, psychological states, social relationships and school functioning. PedsQL 4.0 is a five-point Likert scale for patients to response regarding to the experience over the last month. Higher scores represent better quality of life. Participants will be asked to respond to the Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) at baseline.
Measured: Baseline
Secondary outcomes (4)
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 for children (CES-DC). 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 for children (CES-DC) 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
Resilience ability at baseline
Resilience Scale for Children (RS10) is a 10-item scale to assess the adjustment ability for adapting adverse conditions such as cancer. The scale consists of 10 items with four-point Likert scale ("not at all like me"= "1", "not much like me" = "2", "somewhat like me" = "3", "a lot like me" = "4"). The total score is ranging from 10 to 40 which higher scores represent higher level of resilience. Participants will be asked to respond to the Chinese version of the Resilience Scale for Children (RS10) 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 posted13 Feb 2018
- Study start5 Sep 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Solid TumorStudies 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
- 135 participants (actual)
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
- NCT03430752
- Sponsor's protocol ID
- UW 17-331 (2)
- Status last verified
- Jun 2019
- First submitted
- 6 Feb 2018
- Last updated
- 28 Jun 2019
- 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 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Impact of Cancer and Treatment-related Effects on the Psychological Well-Being and Quality of Life Between Survivors of Childhood Solid Tumors and Leukemia
- ClinicalTrials.gov ID
- NCT03430752
- Acronym / sponsor ID
- UW 17-331 (2)
- Conditions
- Childhood Solid Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 13 Feb 2018 (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 solid tumors.
Detailed description
In general, cancer can be divided into two main categories: blood cancer and solid tumors. Leukemia refer to the cancers in blood while solid tumors refer to the cancers which involve the formation of an abnormal mass without any liquid or cysts. Patients suffer from leukemia are usually have better prognosis which result in better psychological well-being when compared with those suffer from solid tumors (Rodin et al., 2010). The development of solid tumors in children is different from that in adult. Some of the solid tumors such as osteosarcoma, neuroblastoma, rhabdomyosarcoma, Wilms' tumor and retinoblastoma are exclusively found in children. Other types of solid tumors such as brain tumor can also be found in children.
Yet, most of recent studies in Hong Kong have focused in general childhood cancer survivors or their family members but no study has been conducted to focus on the physical and psychological well-being of survivors of childhood solid tumors (Li, Lopez, Chung, Ho, \& Chiu, 2013; Wills, 2009). Therefore, the quality of life and psychological well-being of solid tumors survivors are always be overestimated. The actual psychological needs of solid tumors survivors may be overlooked. 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 solid tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors of Childhood Solid Tumors | – | Other: questionnairesSurvivors of Childhood Solid Tumors were invited to fill in a set of questionnaires. |
| Survivors of Childhood Leukemia | – | Other: questionnairesSurvivors of Childhood Leukemia were invited to fill in a set of questionnaires. |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hong Kong Chinese under the age of 19 years who completed the entire course of treatment at least 6 months and were diagnosed with childhood solid tumors or leukemia under the age of 19 years.
Key inclusion criteria (4 listed)
- (1) Hong Kong Chinese under the age of 30 years at the time of study participation;
- (2) diagnosed with solid tumors or hematological malignancies under the age of 19 years;
- (3) completed the entire course of treatment for at least 6 months;
- (4) 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 will be excluded from this study.
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 the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Chinese version of Rosenberg self-esteem scale, the Chinese version of the Herth Hope Index (HHI) and the Chinese version of Resilience Scale for Children (RS10). | Other | Survivors of Childhood Leukemia, Survivors of Childhood Solid Tumors |
Primary outcome
Quality of Life at baseline
Time frame: Baseline
The Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) consists of 23 items which are designed to measure the quality of life in four particular domains including physical ability, psychological states, social relationships and school functioning. PedsQL 4.0 is a five-point Likert scale for patients to response regarding to the experience over the last month. Higher scores represent better quality of life. Participants will be asked to respond to the Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) at baseline.
4 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
Resilience ability at baseline
Time frame: Baseline
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 28 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Childhood Solid Tumor
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
RecruitingPhase 3
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
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 Solid Tumor, 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: finished, as of the sponsor's last update on 28 Jun 2019. 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?
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 28 Jun 2019.