- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173833
Fulfilling Care Needs of Adolescents With Cancer
May 31, 2017 updated by: National Taiwan University Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
720
Phase
- Not Applicable
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: Wei-Wen Wu
- Phone Number: 88422 2312-3456
- Email: weiwen@ntu.edu.tw
Study Locations
-
-
Test2
-
Test1, Test2, Taiwan, test3
- National Taiwan University Hospital
-
Contact:
- SHIANN-TARNG JOU
- Phone Number: 71716 02-23123456
- Email: stjou4@gmail.com
-
-
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
13 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
The inclusion criteria for adolescents with cancer are
- 13-20 years of age
- previously or currently treated for cancer
- able to communicate in Chinese
- able to comprehend the study information
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
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
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: Experimental group
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom Distress Scale
Time Frame: 2 weeks
|
2 weeks
|
Beck Youth Inventories second edition
Time Frame: 2 weeks
|
2 weeks
|
Posttraumatic Growth Index
Time Frame: 2 weeks
|
2 weeks
|
Resilience Scale
Time Frame: 2 weeks
|
2 weeks
|
Care demand scale
Time Frame: 2 weeks
|
2 weeks
|
Pediatric Quality of Life
Time Frame: 2 weeks
|
2 weeks
|
Acceptability if E-scale
Time Frame: 2 weeks
|
2 weeks
|
Usability scale
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: SHIANN-TARNG LOU, National Taiwan University Hospital Department of Pediatrics
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 (Anticipated)
August 1, 2017
Primary Completion (Anticipated)
July 31, 2020
Study Completion (Anticipated)
July 31, 2020
Study Registration Dates
First Submitted
May 24, 2017
First Submitted That Met QC Criteria
May 31, 2017
First Posted (Actual)
June 2, 2017
Study Record Updates
Last Update Posted (Actual)
June 2, 2017
Last Update Submitted That Met QC Criteria
May 31, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201612238RINA
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.
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