CancerNCT03173833
Fulfilling Care Needs of Adolescents With Cancer
A study testing CAGO questionnaire outcome in people with Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- CAGO questionnaire outcome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Test1, Test2, test3
SHIANN-TARNG JOU, 02-23123456 ext. 71716, stjou4@gmail.com
About this study
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.
- Conditions
- Cancer
- Being tested
- CAGO questionnaire outcome
- Keywords
- cancer patients, quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAGO questionnaire outcomeOther
Also called computer assessment with graphic outcome (CAGO)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CAGO questionnaire outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Distress Scale
Measured: 2 weeks
Beck Youth Inventories second edition
Measured: 2 weeks
Posttraumatic Growth Index
Measured: 2 weeks
Resilience Scale
Measured: 2 weeks
Care demand scale
Measured: 2 weeks
Pediatric Quality of Life
Measured: 2 weeks
Acceptability if E-scale
Measured: 2 weeks
Usability scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 Aug 2017 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHIANN-TARNG LOU, Principal investigator, National Taiwan University Hospital Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173833
- Sponsor's protocol ID
- 201612238RINA
- Status last verified
- Apr 2017
- First submitted
- 24 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fulfilling Care Needs of Adolescents With Cancer
- ClinicalTrials.gov ID
- NCT03173833
- Acronym / sponsor ID
- 201612238RINA
- Conditions
- Cancer
- Keywords
- cancer patients, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: CAGO questionnaire outcomeParticipants 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. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAGO questionnaire outcomeAlso: computer assessment with graphic outcome (CAGO)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 | Experimental group |
Primary outcome
Symptom Distress Scale
Time frame: 2 weeks
Beck Youth Inventories second edition
Time frame: 2 weeks
Posttraumatic Growth Index
Time frame: 2 weeks
Resilience Scale
Time frame: 2 weeks
Care demand scale
Time frame: 2 weeks
Pediatric Quality of Life
Time frame: 2 weeks
Acceptability if E-scale
Time frame: 2 weeks
Usability scale
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHIANN-TARNG LOU principal investigator
National Taiwan University Hospital Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAGO questionnaire outcome in people with Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Wen Wu (2312-3456 ext. 88422, weiwen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Distress Scale (time frame: 2 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.