Anxiety PostoperativeNCT01362842
Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery
An observational study of Anxiety Postoperative and Patient Non-Compliance, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The lung cancer is the most has the life minacity in all kinds of cancers, and it also remains the most common cause of cancer-related death in the world. The group of lung cancer patients are suffer from huge disease impact that came from high mortality. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anxiety Postoperative, Patient Non-Compliance, Psychological Distress
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2011to 30 Nov 2013
- Phase
- Observational
- 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
Study population: Thoracic surgery outpatients
Who may be able to join
- lung cancer patients after surgery
- stage I, II and IIIA
- surgery for 3 months to 5 years
- over 20 years old
Who cannot join
- lung cancer recurrence
- conscious unclear and do not know having cancer
- used to be treat (surgery, chemotherapy or radiotherapy) in 3 months.
- be uncomfortable or cooperate to fill the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
The lung cancer is the most has the life minacity in all kinds of cancers, and it also remains the most common cause of cancer-related death in the world. The group of lung cancer patients are suffer from huge disease impact that came from high mortality. Not only the course of treatment that patients has been diagnosis through operation is more faster, but also those who could be capable of operated are stabilized to keep follow-up at out-patient clinic. But in the next following five years after operation, they may take different dysfunctional level or some kinds of symptom distress. The effect has a great influence on those patients that have to face extended emotional impact, symptom distress and life style change. In addition, most of them concern about recurrent all the time in the remission. These situation needs us to place importance on it.
The purposes of this study are to investigate psychological and physical distress and care needs in operable lung cancer patients receiving surgery. This survey includes two parts of physical and mental condition. First, the investigators are scoring their symptom severity and quality of life to check physical condition. Seconded, the mental condition will use validated questionnaires to realize the relationship of anxiety, depression, uncertainty, fear of recurrence, self-efficacy and needs. Final, compare all of the data to patients' needs.
This study is a cross-sectional designs with convenience sampling that conform to the investigators recruited requirements. The investigators will recruit from the clinic of thoracic surgery in one medical center in Taipei and take five structured requirements. And the investigators are going to collect data from January, 2011 to December, 2012. Also expect results are lung cancer outpatients after surgery that more physical dysfunction or more depress of mental condition, it will lead patients' needs increased or significant difference. In conclusion, this study analyzes their needs in the remission that consequences can be medical professionals' reference material.
Read the detailed description
Inclusion Criteria:
lung cancer patients after surgery stage I, II and IIIA surgery for 3 months to 5 years over 20 years old
Exclusion Criteria:
lung cancer recurrence conscious unclear and do not know having cancer used to be treat (surgery, chemotherapy or radiotherapy) in 3 months. be uncomfortable or cooperate to fill the questionnaire.
- Keywords
- Lung Cancer, Symptom distress, Post-operation, Anxiety, Depression, Uncertainty, Fear of recurrence, Self-efficacy, Needs
- Medical subject headings
- Patient Compliance, Lung Neoplasms, Anxiety Disorders, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study start1 Jan 2011
- Primary completion30 Nov 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety PostoperativeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Yeur-Hur Lai, Ph. D., Study chair, Department of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362842
- Sponsor's protocol ID
- NTUH-201012108RC
- Status last verified
- Dec 2010
- First submitted
- 27 May 2011
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery
- ClinicalTrials.gov ID
- NCT01362842
- Acronym / sponsor ID
- NTUH-201012108RC
- Keywords
- Lung Cancer, Symptom distress, Post-operation, Anxiety, Depression, Uncertainty, Fear of recurrence, Self-efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 30 May 2011 (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 lung cancer is the most has the life minacity in all kinds of cancers, and it also remains the most common cause of cancer-related death in the world. The group of lung cancer patients are suffer from huge disease impact that came from high mortality. Not only the course of treatment that patients has been diagnosis through operation is more faster, but also those who could be capable of operated are stabilized to keep follow-up at out-patient clinic. But in the next following five years after operation, they may take different dysfunctional level or some kinds of symptom distress. The effect has a great influence on those patients that have to face extended emotional impact, symptom distress and life style change. In addition, most of them concern about recurrent all the time in the remission. These situation needs us to place importance on it.
The purposes of this study are to investigate psychological and physical distress and care needs in operable lung cancer patients receiving surgery. This survey includes two parts of physical and mental condition. First, the investigators are scoring their symptom severity and quality of life to check physical condition. Seconded, the mental condition will use validated questionnaires to realize the relationship of anxiety, depression, uncertainty, fear of recurrence, self-efficacy and needs. Final, compare all of the data to patients' needs.
This study is a cross-sectional designs with convenience sampling that conform to the investigators recruited requirements. The investigators will recruit from the clinic of thoracic surgery in one medical center in Taipei and take five structured requirements. And the investigators are going to collect data from January, 2011 to December, 2012. Also expect results are lung cancer outpatients after surgery that more physical dysfunction or more depress of mental condition, it will lead patients' needs increased or significant difference. In conclusion, this study analyzes their needs in the remission that consequences can be medical professionals' reference material.
Detailed description
Inclusion Criteria:
lung cancer patients after surgery stage I, II and IIIA surgery for 3 months to 5 years over 20 years old
Exclusion Criteria:
lung cancer recurrence conscious unclear and do not know having cancer used to be treat (surgery, chemotherapy or radiotherapy) in 3 months. be uncomfortable or cooperate to fill the questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thoracic surgery outpatients
Key inclusion criteria (4 listed)
- lung cancer patients after surgery
- stage I, II and IIIA
- surgery for 3 months to 5 years
- over 20 years old
Key exclusion criteria (4 listed)
- lung cancer recurrence
- conscious unclear and do not know having cancer
- used to be treat (surgery, chemotherapy or radiotherapy) in 3 months.
- be uncomfortable or cooperate to fill the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jan 2020.
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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.
Yeur-Hur Lai, Ph. D. study chair
Department of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Postoperative and Patient Non-Compliance, 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 4 inclusion and 4 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 2 Jan 2020. 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?
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.
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 Jan 2020.