NCT03430752

Brief Summary

The aim of the study is to examine the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of childhood solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

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

September 5, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

February 6, 2018

Last Update Submit

June 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Life at baseline

    The Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) consists of 23 items which are designed to measure the quality of life in four particular domains including physical ability, psychological states, social relationships and school functioning. PedsQL 4.0 is a five-point Likert scale for patients to response regarding to the experience over the last month. Higher scores represent better quality of life. Participants will be asked to respond to the Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) at baseline.

    Baseline

Secondary Outcomes (4)

  • Levels of self-esteem at baseline

    Baseline

  • Number of depressive symptoms at baseline

    Baseline

  • Level of sense of hope at baseline

    Baseline

  • Resilience ability at baseline

    Baseline

Study Arms (2)

Survivors of Childhood Solid Tumors

Survivors of Childhood Solid Tumors were invited to fill in a set of questionnaires.

Other: questionnaires

Survivors of Childhood Leukemia

Survivors of Childhood Leukemia were invited to fill in a set of questionnaires.

Other: questionnaires

Interventions

Participants were asked to respond to the questionnaires including the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Chinese version of Rosenberg self-esteem scale, the Chinese version of the Herth Hope Index (HHI) and the Chinese version of Resilience Scale for Children (RS10).

Survivors of Childhood LeukemiaSurvivors of Childhood Solid Tumors

Eligibility Criteria

Age6 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Hong Kong Chinese under the age of 19 years who completed the entire course of treatment at least 6 months and were diagnosed with childhood solid tumors or leukemia under the age of 19 years.

You may qualify if:

  • (1) Hong Kong Chinese under the age of 30 years at the time of study participation;
  • (2) diagnosed with solid tumors or hematological malignancies under the age of 19 years;
  • (3) completed the entire course of treatment for at least 6 months;
  • (4) able to speak fluent Cantonese and read Chinese.

You may not qualify if:

  • Survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ho Cheung William Li

    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

February 6, 2018

First Posted

February 13, 2018

Study Start

September 5, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations