NCT02928731

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

October 6, 2016

Last Update Submit

October 25, 2016

Conditions

Keywords

CancerQuality of lifeChild

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (2)

  • Coping strategies used to deal with the cancer and the therapy-related symptoms

    baseline

  • Physical activity level

    baseline

Study Arms (2)

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).

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.

Other: Questionnaires set 2

Interventions

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.

Children with cancer

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

Healthy children

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Mainland Chinese hospitalized Children with cancer in the wards of 3 tertiary public hospitals in Beijing.

You may qualify if:

  • 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).

You may not qualify if:

  • children with cognitive and learning problems identified from their medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • William Ho Cheung LI, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 10, 2016

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations