NCT04888195

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

May 3, 2021

Last Update Submit

April 12, 2022

Conditions

Keywords

blood cancerchemotherapy

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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

    At baseline

Study Arms (1)

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

Other: Questionnaire

Interventions

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.

Questionnaire

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We will recruit pediatric patients with blood cancer in the Hong Kong Children's Hospital

You may qualify if:

  • aged 5 - 17 years old
  • diagnosed with blood cancer but not yet receive any chemotherapy
  • able to communicate with Cantonese and read Chinese

You may not qualify if:

  • who are scheduled to have concurrent cancer treatment
  • with recurrent malignancy
  • medical condition, or cognitive and learning problems in their medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ka Yan Ho

Hong Kong, Hong Kong,China, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ka Yan Ho, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Yan Ho, PhD

CONTACT

Ka Wai Lam, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 17, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations