ChildNCT02928731
Impact of Cancer on the Physical and Psychological Well-being of Children in Mainland China
An observational study of Child, run by The University of Hong Kong at 1 site in China.
Trial summary
The aim of this study is to explore the impact of cancer and therapy-related symptoms on Mainland Chinese children's physical and psychological well-being. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Child
- What is being tested?
- Questionnaires set 1 and Questionnaires set 2
- How many people
- 425 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jan 2015
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mainland Chinese hospitalized Children with cancer in the wards of 3 tertiary public hospitals in Beijing.
Who may be able to join
- all children should be ages 9-16 years,
- they should be able to speak and read Chinese,
- they should have been diagnosed with cancer for at least 2 months and be currently undergoing active treatment,
- they should aware of their diseases (cancer).
Who cannot join
- children with cognitive and learning problems identified from their medical records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Cancer and Therapy-related Symptoms on Mainland Chinese Children's Physical and Psychological Well-being: An Exploratory Study
The aim of this study is to explore the impact of cancer and therapy-related symptoms on Mainland Chinese children's physical and psychological well-being.
Read the detailed description
According to WHO, the annual cancer death has increased to 13 million a year . The cancer incidence of children has also been growing. As the advancement of diagnostic procedure and treatment, the chance of survival has risen considerably over the past decades. The mortality rate of childhood cancer in mainland China has also dramatically decreased during the recent decades.
Nonetheless, the survivors experience low quality of life. When undergoing diagnostic procedures and treatments, children often suffer from multiple symptoms concurrently, such as nausea, fatigue, decreased appetite, pain, and feeling drowsy. These physical symptoms may have long-lasting effects as the treatments last longer. The increase in severity, duration and frequency of physical symptoms may negatively affect recovery of patients in terms of their functional status and positivity, subsequently leading to sadness and anger . Therefore, children will be anxious and stressful when they have cancer. There is considerably evidence to show that children who experience more symptoms have higher levels of depressiveness as well as lower level of physical and psychological functions.
As a matter of fact, studies have found that coping strategies may affect the quality of life. When going through these therapies-related symptoms, children with cancer will feel helpless and have extreme reactions. They may adopt different types of coping strategies, such as screaming, refusing to have treatments or seeking comfort from parents. Some of the strategies may reduce the psychological pressure temporarily, while some other coping strategies can minimize physical pain. All of these may have their impact on quality of life in different degrees. Therefore, recognizing the effect of different coping strategies on both therapy-related symptoms and quality of life is a crucial step to design appropriate interventions that help cancer children to ease treatment related symptoms, improve their quality of life and promote their psychological well-being. On the other hand, a review of the literature has revealed that physical activity is beneficial to cancer patients in terms of their QoL as well as symptom management. Indeed, promoting regular physical activity has been incorporated to rehabilitation guideline for childhood cancer survivors in recent years, so as to enhance both their physical and functional well-beings, as well as, their psychological and emotional well-beings. In fact, the result of a cross-sectional study did show that there is a positive correlation between physical activity level and health-related quality of life . Another study conducted in western country also demonstrated that physical activity level is related to severity of fatigue and health-related quality of life of cancer patients.
Notwithstanding the fact that regular physical activity is beneficial to cancer patients in terms of their psychological health, many children with cancer are recommend not to engage in regular physical activity. They are often advised to take more rest so as to avoid cancer-related or treatment-related fatigue. Given that, it seems also important for us, as health care professionals to examine the physical activity of children hospitalized with cancer before we will be able to design appropriate interventions to promote the adoption and maintenance of regular physical activity, with an ultimate goal to enhance their QoL and psychological well-being.
Although there is compelling evidence to support that therapy-related symptoms, coping strategies and physical activity may have a significant impact on children's quality of life, all of these studies were conducted in western countries, in which, it is hard to reflect the phenomenon in China. On the other hand, notwithstanding the fact that there were several studies conducted in Hong Kong to examine relationship between therapy-related symptoms, coping strategies, physical activity and QoL in cancer children, cultural discrepancies between Hong Kong and China have made applying this finding to be difficult.
this study will explore explore the Impact of Cancer and Therapy-related symptoms on Mainland Chinese Children's Physical and Psychological well-being.
Mainland Chinese hospitalized Children with cancer in the wards of 3 tertiary public hospitals in Beijing will be invited to participate in the study. The pediatric oncology units of these three hospitals will be similar in nature and setting.
The hospitalized children with cancer, who met the inclusion criteria for the study, will be invited to participate. The inclusion criteria are: (1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, (3) they should have been diagnosed with cancer for at least 2 months and be currently undergoing active treatment, and (4) they should aware of their diseases (cancer). We excluded children with cognitive and learning problems identified from their medical records.
To compare the impact of therapy-related symptoms on children's quality of life and physical activity level, a group of healthy children having similar standard of living in Mainland China will be invited to participate in the study. The inclusion criteria are: (1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, and (3) they should not have cancer or any other chronic illness.
Approval of the study will be obtained from the hospital ethics committees in Mainland China and the University of Hong Kong.
Firstly, the research student will check the eligibility of cancer children by screening their medical records. The research student will then approach the eligible children who are hospitalized in the wards of the pediatric oncology unit. Written consent will be obtained from their parents after they are told about the details of this study. They will be given an option to participate or refuse their child's involvement in the study. In addition, the children who agree to participate will be also invited to put their names on a special child assent form. Both of them will be assured that their participation is totally voluntary and they are allowed to withdraw from the study at any time. After obtaining the participants' demographics from the parents, the children will be asked to complete a set of questionnaires which consists of the Chinese version of Pediatric Quality of life Inventory, Chinese University of Hong Kong: Physical Activity Rating for Children and Youth and Coping Behavior Checklist. About 20 of them will also be selected at random to have a one-to-one, 20 to 30 minutes, semi-structured interview, and all the interviews will be tape-recorded.
Another group of healthy children will be recruited by similar procedures in the community and they will be asked to respond to the same set of questionnaires except the Coping Behavior Checklist.
The independent t-test and chi-square will be used to assess the factors. Descriptive statistics will be used to calculate the mean scores and standard deviation of different scales.
The qualitative data will be analyzed and reported followed by the seven-step analytical procedure of Colaizzi.
- Conditions
- Child
- Being tested
- Questionnaires set 1, Questionnaires set 2
- Keywords
- Cancer, Quality of life, Child
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires set 1Other
Participants were asked to respond to the Chinese version of the Coping Behavior Checklist for Chinese Children, the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth, and the Pediatric Quality of life Inventory: cancer module.
Questionnaires set 2Other
Participants were asked to respond to the Chinese version of the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth,and the Pediatric Quality of life Inventory: generic module
| Study group | Role | What they receive |
|---|---|---|
| Children with cancer | Children met the criteria below were invited to fill in the questionnaires set 1.
(1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, (3) they should have been diagnosed with cancer for at least 2 months and be currently undergoing active treatment, and (4) they should aware of their diseases (cancer). Receives: Other: Questionnaires set 1 | |
| Healthy children | Children met the criteria below were invited to fill in the questionnaires set 2.
(1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, and (3) they should not have cancer or any other chronic illness. Receives: Other: Questionnaires set 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
The quality of life of the participants will be measured by the Pediatric Quality of life Inventory. This instrument consists 27items with 8 subscales。 Items are reverse-scored and linearly transformed into a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) by asking the participants how much of a problem has been experienced over the last month. Participants will be asked to respond to the Chinese version of the Pediatric Quality of Life Inventory at baseline.
Measured: baseline
Secondary outcomes (2)
Coping strategies used to deal with the cancer and the therapy-related symptoms
The Coping strategies of the participants will be measured by the Coping Behavior Checklist for Chinese Children. It started with the question" supposing you were faced with a very stressful event, such as having to go to hospital for surgery, what would you do?" And followed by 8 items. Items 1, 2 and 8 (problem-focused strategies) are scored from 0 to 2 (0 = 'Hardly ever', 1 = 'Sometimes', 2 = 'Often'). Items 3, 4, 5, 6,and 7 (emotional-focused strategy) are scored from 2 to 0 (0 = 'Often', 1 = 'Sometimes', 2 = 'Hardly ever'). The total possible scores range from 0 to 10, and scores of 0 to 3, 4 to 6 and 7 to 10 are interpreted as corresponding to emotional-focused, mixed-focused and problem-focused responses, respectively.Participants will be asked to respond to the Coping Behavior Checklist for Chinese Children at baseline.
Measured: baseline
Physical activity level
The physical activity level of the participants will be measured by The Chinese University of Hong Kong: Physical Activity Rating for Children and Youth. The instrument adopts an 11- point scoring system (0-10) to grade levels of physical activity ranging from no exercise at all (0) to vigorous exercise on most days (10) and taking into consideration the frequency, duration, and intensity of the activity concerned. Accordingly, scores of 0-2, 3-6, and 7-10 are respectively interpreted as low, moderate, and high physical activity levels. Participants will be asked to response to the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth 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 posted10 Oct 2016 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies 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
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Ho Cheung LI, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928731
- Sponsor's protocol ID
- Physical_Mainland
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cancer and Therapy-related Symptoms on Mainland Chinese Children's Physical and Psychological Well-being: An Exploratory Study
- ClinicalTrials.gov ID
- NCT02928731
- Acronym / sponsor ID
- Physical_Mainland
- Conditions
- Child
- Keywords
- Cancer, Quality of life, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Oct 2016 (estimated)
- 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 this study is to explore the impact of cancer and therapy-related symptoms on Mainland Chinese children's physical and psychological well-being.
Detailed description
According to WHO, the annual cancer death has increased to 13 million a year . The cancer incidence of children has also been growing. As the advancement of diagnostic procedure and treatment, the chance of survival has risen considerably over the past decades. The mortality rate of childhood cancer in mainland China has also dramatically decreased during the recent decades.
Nonetheless, the survivors experience low quality of life. When undergoing diagnostic procedures and treatments, children often suffer from multiple symptoms concurrently, such as nausea, fatigue, decreased appetite, pain, and feeling drowsy. These physical symptoms may have long-lasting effects as the treatments last longer. The increase in severity, duration and frequency of physical symptoms may negatively affect recovery of patients in terms of their functional status and positivity, subsequently leading to sadness and anger . Therefore, children will be anxious and stressful when they have cancer. There is considerably evidence to show that children who experience more symptoms have higher levels of depressiveness as well as lower level of physical and psychological functions.
As a matter of fact, studies have found that coping strategies may affect the quality of life. When going through these therapies-related symptoms, children with cancer will feel helpless and have extreme reactions. They may adopt different types of coping strategies, such as screaming, refusing to have treatments or seeking comfort from parents. Some of the strategies may reduce the psychological pressure temporarily, while some other coping strategies can minimize physical pain. All of these may have their impact on quality of life in different degrees. Therefore, recognizing the effect of different coping strategies on both therapy-related symptoms and quality of life is a crucial step to design appropriate interventions that help cancer children to ease treatment related symptoms, improve their quality of life and promote their psychological well-being. On the other hand, a review of the literature has revealed that physical activity is beneficial to cancer patients in terms of their QoL as well as symptom management. Indeed, promoting regular physical activity has been incorporated to rehabilitation guideline for childhood cancer survivors in recent years, so as to enhance both their physical and functional well-beings, as well as, their psychological and emotional well-beings. In fact, the result of a cross-sectional study did show that there is a positive correlation between physical activity level and health-related quality of life . Another study conducted in western country also demonstrated that physical activity level is related to severity of fatigue and health-related quality of life of cancer patients.
Notwithstanding the fact that regular physical activity is beneficial to cancer patients in terms of their psychological health, many children with cancer are recommend not to engage in regular physical activity. They are often advised to take more rest so as to avoid cancer-related or treatment-related fatigue. Given that, it seems also important for us, as health care professionals to examine the physical activity of children hospitalized with cancer before we will be able to design appropriate interventions to promote the adoption and maintenance of regular physical activity, with an ultimate goal to enhance their QoL and psychological well-being.
Although there is compelling evidence to support that therapy-related symptoms, coping strategies and physical activity may have a significant impact on children's quality of life, all of these studies were conducted in western countries, in which, it is hard to reflect the phenomenon in China. On the other hand, notwithstanding the fact that there were several studies conducted in Hong Kong to examine relationship between therapy-related symptoms, coping strategies, physical activity and QoL in cancer children, cultural discrepancies between Hong Kong and China have made applying this finding to be difficult.
this study will explore explore the Impact of Cancer and Therapy-related symptoms on Mainland Chinese Children's Physical and Psychological well-being.
Mainland Chinese hospitalized Children with cancer in the wards of 3 tertiary public hospitals in Beijing will be invited to participate in the study. The pediatric oncology units of these three hospitals will be similar in nature and setting.
The hospitalized children with cancer, who met the inclusion criteria for the study, will be invited to participate. The inclusion criteria are: (1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, (3) they should have been diagnosed with cancer for at least 2 months and be currently undergoing active treatment, and (4) they should aware of their diseases (cancer). We excluded children with cognitive and learning problems identified from their medical records.
To compare the impact of therapy-related symptoms on children's quality of life and physical activity level, a group of healthy children having similar standard of living in Mainland China will be invited to participate in the study. The inclusion criteria are: (1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, and (3) they should not have cancer or any other chronic illness.
Approval of the study will be obtained from the hospital ethics committees in Mainland China and the University of Hong Kong.
Firstly, the research student will check the eligibility of cancer children by screening their medical records. The research student will then approach the eligible children who are hospitalized in the wards of the pediatric oncology unit. Written consent will be obtained from their parents after they are told about the details of this study. They will be given an option to participate or refuse their child's involvement in the study. In addition, the children who agree to participate will be also invited to put their names on a special child assent form. Both of them will be assured that their participation is totally voluntary and they are allowed to withdraw from the study at any time. After obtaining the participants' demographics from the parents, the children will be asked to complete a set of questionnaires which consists of the Chinese version of Pediatric Quality of life Inventory, Chinese University of Hong Kong: Physical Activity Rating for Children and Youth and Coping Behavior Checklist. About 20 of them will also be selected at random to have a one-to-one, 20 to 30 minutes, semi-structured interview, and all the interviews will be tape-recorded.
Another group of healthy children will be recruited by similar procedures in the community and they will be asked to respond to the same set of questionnaires except the Coping Behavior Checklist.
The independent t-test and chi-square will be used to assess the factors. Descriptive statistics will be used to calculate the mean scores and standard deviation of different scales.
The qualitative data will be analyzed and reported followed by the seven-step analytical procedure of Colaizzi.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cancer | – | Other: Questionnaires set 1Children met the criteria below were invited to fill in the questionnaires set 1. (1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, (3) they should have been diagnosed with cancer for at least 2 months and be currently undergoing active treatment, and (4) they should aware of their diseases (cancer). |
| Healthy children | – | Other: Questionnaires set 2Children met the criteria below were invited to fill in the questionnaires set 2. (1) all children should be ages 9-16 years, (2) they should be able to speak and read Chinese, and (3) they should not have cancer or any other chronic illness. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mainland Chinese hospitalized Children with cancer in the wards of 3 tertiary public hospitals in Beijing.
Key inclusion criteria (4 listed)
- all children should be ages 9-16 years,
- they should be able to speak and read Chinese,
- they should have been diagnosed with cancer for at least 2 months and be currently undergoing active treatment,
- they should aware of their diseases (cancer).
Key exclusion criteria (1 listed)
- children with cognitive and learning problems identified from 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 set 1Participants were asked to respond to the Chinese version of the Coping Behavior Checklist for Chinese Children, the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth, and the Pediatric Quality of life Inventory: cancer module. | Other | Children with cancer |
| Questionnaires set 2Participants were asked to respond to the Chinese version of the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth,and the Pediatric Quality of life Inventory: generic module | Other | Healthy children |
Primary outcome
Quality of life
Time frame: baseline
The quality of life of the participants will be measured by the Pediatric Quality of life Inventory. This instrument consists 27items with 8 subscales。 Items are reverse-scored and linearly transformed into a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) by asking the participants how much of a problem has been experienced over the last month. Participants will be asked to respond to the Chinese version of the Pediatric Quality of Life Inventory at baseline.
2 secondary outcomes
Coping strategies used to deal with the cancer and the therapy-related symptoms
Time frame: baseline
Physical activity level
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 26 Oct 2016.
- 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.
William Ho Cheung LI, PhD 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 Child, run by The University of Hong Kong at 1 site in China.
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 26 Oct 2016. 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 China. 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 (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 26 Oct 2016.