NCT01362842

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2013

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2010

Enrollment Period

2.9 years

First QC Date

May 27, 2011

Last Update Submit

December 30, 2019

Conditions

Keywords

Lung CancerSymptom distressPost-operationAnxietyDepressionUncertaintyFear of recurrenceSelf-efficacyNeeds

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thoracic surgery outpatients

You may qualify if:

  • lung cancer patients after surgery
  • stage I, II and IIIA
  • surgery for 3 months to 5 years
  • over 20 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hosptial

Taipei, Taiwan

Location

MeSH Terms

Conditions

Patient ComplianceLung NeoplasmsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMental DisordersBehavioral Symptoms

Study Officials

  • Yeur-Hur Lai, Ph. D.

    Department of Nursing, College of Medicine, National Taiwan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2011

First Posted

May 30, 2011

Study Start

January 1, 2011

Primary Completion

November 30, 2013

Study Completion

November 30, 2013

Last Updated

January 2, 2020

Record last verified: 2010-12

Locations