- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04888195
Symptom Clusters in Hong Kong Chinese Children With Blood Cancer
April 12, 2022 updated by: Dr Eva Ho, The Hong Kong Polytechnic University
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
120
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: Ka Wai Lam, PhD
- Phone Number: 27666420
- Email: kwkatlam@polyu.edu.hk
Study Locations
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Hong Kong,China
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Hong Kong, Hong Kong,China, Hong Kong, 0000
- Recruiting
- Ka Yan Ho
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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
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We will recruit pediatric patients with blood cancer in the Hong Kong Children's Hospital
Description
Inclusion Criteria:
- aged 5 - 17 years old
- diagnosed with blood cancer but not yet receive any chemotherapy
- able to communicate with Cantonese and read Chinese
Exclusion Criteria:
- who are scheduled to have concurrent cancer treatment
- with recurrent malignancy
- medical condition, or cognitive and learning problems in their medical records
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The therapy-related symptom checklist for children (TRSC-C)
Time Frame: Before chemotherapy
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For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
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Before chemotherapy
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The therapy-related symptom checklist for children (TRSC-C) at 1-week
Time Frame: At 1-week follow-up
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For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
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At 1-week follow-up
|
|
The therapy-related symptom checklist for children (TRSC-C) at 1-month
Time Frame: At 1-month follow-up
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For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
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At 1-month follow-up
|
|
The therapy-related symptom checklist for children (TRSC-C) at 3-month
Time Frame: At 3-month follow-up
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For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
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At 3-month follow-up
|
|
The therapy-related symptom checklist for children (TRSC-C) at 6-month
Time Frame: At 6-month follow-up
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For measuring the occurrence and severity of symptoms experienced by patients aged 5-17 when they undergo cancer treatment.
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At 6-month follow-up
|
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Demographic sheet
Time Frame: At baseline
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collect the background information of our subjects, including their age, gender, educational attainment, parents' marital status and religious belief
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At baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ka Yan Ho, phd, The Hong Kong Polytechnic University
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 1, 2021
Primary Completion (Anticipated)
September 1, 2024
Study Completion (Anticipated)
September 1, 2024
Study Registration Dates
First Submitted
May 3, 2021
First Submitted That Met QC Criteria
May 11, 2021
First Posted (Actual)
May 17, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC_Blood_cancer
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
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.