NCT03173833

Brief Summary

The aim of phase 1 of this study is to develop a care need scale (CNS) for adolescents with cancer. The aim of phase 2 is to examine the mediating role of care needs between physical and psychosocial dysfunction and QoL, and to explore the recovery trajectory and its predictors regarding the care needs, physical and psychosocial factors, and the QoL of adolescents with cancer at the first, second, and third 3-month periods after initiating on-treatment and off-treatment. The aim of phase 3 is to examine the effectiveness of the computerized assessment with graphic outcome (CAGO) for fulfilling the care needs of adolescents with cancer, its acceptability for adolescents with cancer, and its usability for clinicians in pediatric oncology units.

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
720

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable cancer

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 24, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

June 2, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

May 24, 2017

Last Update Submit

May 31, 2017

Conditions

Keywords

cancer patients, quality of life

Outcome Measures

Primary Outcomes (8)

  • Symptom Distress Scale

    2 weeks

  • Beck Youth Inventories second edition

    2 weeks

  • Posttraumatic Growth Index

    2 weeks

  • Resilience Scale

    2 weeks

  • Care demand scale

    2 weeks

  • Pediatric Quality of Life

    2 weeks

  • Acceptability if E-scale

    2 weeks

  • Usability scale

    2 weeks

Study Arms (2)

Control group

NO INTERVENTION

Participants will not receive the outcome of their questionnaire in the form of computerized assessment with graphic outcome (CAGO) after the first time they fill in the questionnaire. And they will be able to discuss their care needs with their health care practitioners.

Experimental group

EXPERIMENTAL

Participants will receive the outcome of their questionnaire in the form of computerized assessment with graphic outcome (CAGO) every time after the first time they fill in the questionnaire. And they will be able to discuss their care needs with their health care practitioners.

Other: CAGO questionnaire outcome

Interventions

Every time when cancer patients fulfill the following questionnaires, SDS, PTGI, CNS, PedsQL, the outcome of the questionnaires will be provided to the experimental group of the participants by using a computer assessment with graphic outcome.

Also known as: computer assessment with graphic outcome (CAGO)
Experimental group

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • previously or currently treated for cancer
  • able to communicate in Chinese
  • able to comprehend the study information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Test1, Test2, test3, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • SHIANN-TARNG LOU

    National Taiwan University Hospital Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

June 2, 2017

Study Start

August 1, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

June 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations