ChildNCT04888195
Symptom Clusters in Hong Kong Chinese Children With Blood Cancer
An observational study of Child, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Pediatric blood cancer is the most common childhood malignancy. Despite its survival has been substantially improved, children still have to pay a high price for numerous distressing symptoms resulted from chemotherapy. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Child
- What is being tested?
- Questionnaire
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to 1 Sep 2024
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: We will recruit pediatric patients with blood cancer in the Hong Kong Children's Hospital
Who may be able to join
- aged 5 - 17 years old
- diagnosed with blood cancer but not yet receive any chemotherapy
- able to communicate with Cantonese and read Chinese
Who cannot join
- who are scheduled to have concurrent cancer treatment
- with recurrent malignancy
- medical condition, or cognitive and learning problems in their medical records
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Ka Yan Ho
Hong Kong, Hong Kong,China, 0000
Ka Yan Ho, Phd, 27666417, kyeva.ho@polyu.edu.hk
About this study
Official title: Symptom Clusters in Hong Kong Chinese Children With Blood Cancer:: A Longitudinal Study
Pediatric blood cancer is the most common childhood malignancy. Despite its survival has been substantially improved, children still have to pay a high price for numerous distressing symptoms resulted from chemotherapy. Previous studies related to symptom experiences mainly focus on individual symptoms, rather than on multiple symptoms. Understanding these distressing symptoms may help healthcare professionals to develop appropriate and effective interventions with the aims of alleviating symptom severity and thus promoting the child's psychosocial well-being and quality of life.
Read the detailed description
A longitudinal study design will be conducted. A sample of 120 patients age 5-17years, diagnosed with blood cancer but not yet receive any chemotherapy and able to communicate with Cantonese and read Chinese will be recruited in the pediatric oncology ward of Hong Kong Children's Hospital.
- Conditions
- Child
- Being tested
- Questionnaire
- Keywords
- blood cancer, chemotherapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Participants will complete a set of validated questionnaires (TRSC-C and demographic sheet) before chemotherapy. They also have to complete the same questionnaires (TRSC-C) again within 1 week after the 1st, 2nd, 3rd, 4th , 5th and 6th courses of chemotherapy via telephone interview by our research assistants.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | This study aims to examine the cancer patient's symptom clusters and their changes over chemotherapy among pediatric patients with blood cancer in Hong Kong Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The therapy-related symptom checklist for children (TRSC-C)
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
Measured: Before chemotherapy
The therapy-related symptom checklist for children (TRSC-C) at 1-week
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
Measured: At 1-week follow-up
The therapy-related symptom checklist for children (TRSC-C) at 1-month
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
Measured: At 1-month follow-up
The therapy-related symptom checklist for children (TRSC-C) at 3-month
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
Measured: At 3-month follow-up
The therapy-related symptom checklist for children (TRSC-C) at 6-month
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
Measured: At 6-month follow-up
Demographic sheet
collect the background information of our subjects, including their age, gender, educational attainment, parents' marital status and religious belief
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
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 Hong Kong Polytechnic UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Ka Yan Ho, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888195
- Sponsor's protocol ID
- SC_Blood_cancer
- Status last verified
- Apr 2022
- First submitted
- 3 May 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Clusters in Hong Kong Chinese Children With Blood Cancer:: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT04888195
- Acronym / sponsor ID
- SC_Blood_cancer
- Conditions
- Child
- Keywords
- blood cancer, chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 17 May 2021 (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.
Pediatric blood cancer is the most common childhood malignancy. Despite its survival has been substantially improved, children still have to pay a high price for numerous distressing symptoms resulted from chemotherapy. Previous studies related to symptom experiences mainly focus on individual symptoms, rather than on multiple symptoms. Understanding these distressing symptoms may help healthcare professionals to develop appropriate and effective interventions with the aims of alleviating symptom severity and thus promoting the child's psychosocial well-being and quality of life.
Detailed description
A longitudinal study design will be conducted. A sample of 120 patients age 5-17years, diagnosed with blood cancer but not yet receive any chemotherapy and able to communicate with Cantonese and read Chinese will be recruited in the pediatric oncology ward of Hong Kong Children's Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Other: QuestionnaireThis study aims to examine the cancer patient's symptom clusters and their changes over chemotherapy among pediatric patients with blood cancer in Hong Kong |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We will recruit pediatric patients with blood cancer in the Hong Kong Children's Hospital
Key inclusion criteria (3 listed)
- aged 5 - 17 years old
- diagnosed with blood cancer but not yet receive any chemotherapy
- able to communicate with Cantonese and read Chinese
Key exclusion criteria (3 listed)
- who are scheduled to have concurrent cancer treatment
- with recurrent malignancy
- medical condition, or cognitive and learning problems in 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 |
|---|---|---|
| QuestionnaireParticipants will complete a set of validated questionnaires (TRSC-C and demographic sheet) before chemotherapy. They also have to complete the same questionnaires (TRSC-C) again within 1 week after the 1st, 2nd, 3rd, 4th , 5th and 6th courses of chemotherapy via telephone interview by our research assistants. | Other | Questionnaire |
Primary outcome
The therapy-related symptom checklist for children (TRSC-C)
Time frame: Before chemotherapy
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
The therapy-related symptom checklist for children (TRSC-C) at 1-week
Time frame: At 1-week follow-up
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
The therapy-related symptom checklist for children (TRSC-C) at 1-month
Time frame: At 1-month follow-up
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
The therapy-related symptom checklist for children (TRSC-C) at 3-month
Time frame: At 3-month follow-up
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
The therapy-related symptom checklist for children (TRSC-C) at 6-month
Time frame: At 6-month follow-up
For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
Demographic sheet
Time frame: At baseline
collect the background information of our subjects, including their age, gender, educational attainment, parents' marital status and religious belief
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- 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.
Ka Yan Ho, PhD principal investigator
The Hong Kong Polytechnic University
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 Hong Kong Polytechnic University 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 3 inclusion and 3 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 19 Apr 2022. 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 Ka Yan Ho, PhD (27666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The therapy-related symptom checklist for children (TRSC-C) (time frame: Before chemotherapy). The study lists 6 primary outcomes in all. 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 19 Apr 2022.