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Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362842
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Taiwan University
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date May 27, 2011
First Posted Date May 30, 2011
Last Update Posted Date January 2, 2020
Actual Study Start Date January 1, 2011
Actual Primary Completion Date November 30, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery
Official Title Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Thoracic surgery outpatients
Condition
  • Anxiety Postoperative
  • Patient Non-Compliance
  • Psychological Distress
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 30, 2019)
200
Original Estimated Enrollment
 (submitted: May 27, 2011)
300
Actual Study Completion Date November 30, 2013
Actual Primary Completion Date November 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01362842
Other Study ID Numbers NTUH-201012108RC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators National Taiwan University
Investigators
Study Chair: Yeur-Hur Lai, Ph. D. Department of Nursing, College of Medicine, National Taiwan University
PRS Account National Taiwan University Hospital
Verification Date December 2010