Lung CancerPhase 2NCT02070497
Effectiveness of Nursing Case Management for Lung Cancer Patients
A Phase 2 study testing case management in people with Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2010to Dec 2011
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with lung cancer
Who cannot join
- younger than 20 years old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital Research Ethics Committee
Taipei, Taipei, 10002
About this study
Official title: The Effectiveness of Nursing Case Management for Lung Cancer Patients in a Taiwan Medical Center
The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center.
Read the detailed description
Purpose: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance, patients' satisfaction with healthcare, and staffs' satisfaction with case management.
Methods: The study will employ a quasi-experimental research design. The patients with new-diagnosed lung cancer and accepting case management will be assigned to the experimental group； The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management will be assigned to the control group；The third group is the patients with non-new-diagnosed lung cancer and with accepting case management. The staffs are the doctors within the lung cancer medical team.
The lung cancer case management database, patients' satisfaction questionnaire, and staffs' satisfaction questionnaire will be used to measure the effectiveness. Statistical software SPSS for Windows version 17.0 will be used to analyze the data.
Expected results: The research outcome will to confirm the impact of case management on the lung cancer patients and could be the reference data for future cancer case management model.
- Conditions
- Lung Cancer
- Being tested
- case management
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case managementOther
Also called nursing case management
case management group will accept the case manager's service; the control group will just accept the routine care
| Study group | Role | What they receive |
|---|---|---|
| case management_new | Experimental | The patients with new-diagnosed lung cancer and accepting case management Receives: Other: case management |
| case management_old | Experimental | the patients with non-new-diagnosed lung cancer and with accepting case management Receives: Other: case management |
| control group | No intervention | The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
chart review
We reviewed the chart and lung cancer case management database to collect the patients' healthy outcome. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance.
Measured: One year
Secondary outcomes (2)
patients' satisfaction questionnaire
Measured: 1 day
staffs' satisfaction questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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 2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Ying Hong, RN, Master, Study chair, Department of Nursing, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070497
- Sponsor's protocol ID
- 201005083R
- Status last verified
- Feb 2014
- First submitted
- 19 Nov 2012
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Nursing Case Management for Lung Cancer Patients in a Taiwan Medical Center
- ClinicalTrials.gov ID
- NCT02070497
- Acronym / sponsor ID
- 201005083R
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Feb 2014 (estimated)
- 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 study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center.
Detailed description
Purpose: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance, patients' satisfaction with healthcare, and staffs' satisfaction with case management.
Methods: The study will employ a quasi-experimental research design. The patients with new-diagnosed lung cancer and accepting case management will be assigned to the experimental group； The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management will be assigned to the control group；The third group is the patients with non-new-diagnosed lung cancer and with accepting case management. The staffs are the doctors within the lung cancer medical team.
The lung cancer case management database, patients' satisfaction questionnaire, and staffs' satisfaction questionnaire will be used to measure the effectiveness. Statistical software SPSS for Windows version 17.0 will be used to analyze the data.
Expected results: The research outcome will to confirm the impact of case management on the lung cancer patients and could be the reference data for future cancer case management model.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| case management_new | Experimental | Other: case managementThe patients with new-diagnosed lung cancer and accepting case management |
| case management_old | Experimental | Other: case managementthe patients with non-new-diagnosed lung cancer and with accepting case management |
| control group | No intervention | –The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with lung cancer
Key exclusion criteria (1 listed)
- younger than 20 years old
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 |
|---|---|---|
| case managementAlso: nursing case managementcase management group will accept the case manager's service; the control group will just accept the routine care | Other | case management_new, case management_old |
Primary outcome
chart review
Time frame: One year
We reviewed the chart and lung cancer case management database to collect the patients' healthy outcome. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance.
2 secondary outcomes
patients' satisfaction questionnaire
Time frame: 1 day
staffs' satisfaction questionnaire
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
Ming-Ying Hong, RN, Master study chair
Department of Nursing, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing case management in people with Lung 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 25 Feb 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chart review (time frame: One year). 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 25 Feb 2014.