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Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer Patients

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: NCT03881046
Recruitment Status : Enrolling by invitation
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hamide Sahin, Hacettepe University

Tracking Information
First Submitted Date March 15, 2019
First Posted Date March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date September 1, 2018
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2019)
Activities Of Daily Living [ Time Frame: 1st day ]
Daily Living Activities will be evaluated using the Londrina Protocol.The protocol consists of 5 stations. Stations are including organizing books on the table, 18 meters walking by carrying 10% of body weight symmetrically, arranging books by putting them on shelves, hanging the laundry in the laundry basket and walking 18 meters. İndividual will do these activities at his own pace and the time will be recorded at the end.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 18, 2019)
  • Life Quality [ Time Frame: 1st Day ]
    Quality of life will be measured using Core Quality of Life Questionnaire (EORTC QLQ-C30) The questionnaire consists of 30 questions and provides information on quality of life and symptoms.
  • Peripheral Muscle Strength [ Time Frame: 1st Day ]
    Muscle strength will be evaluated by force measuring dynamometer device 3 times. M.Quadriceps Femoris, shoulder abduction, shoulder flexion, elbow flexion, elbow extension and hand grip strength of all cases will be measured.
  • Dyspnoea [ Time Frame: 1st Day ]
    Dyspnoea will be evaluated using the Medical Research Council Dyspnoea Scale. The Medical Research Council Dyspnoea Scale has a score of 0-4. İn this scoring system 0 indicates that there is no dyspnoea, whereas 4 indicates that the dyspnoea is too high.
  • Respiratory Functions [ Time Frame: 1st Day ]
    Respiratory functions will be measured by spirometric measurement. This measurement will give us FEV1 FVC FEV1 / FVC values.
  • Exercise Capacity [ Time Frame: 1st Day ]
    6 Minute walk test will be used.In the test, the person will be asked to walk as fast as possible in a 30-meter corridor and the walking distance will be recorded in 6 minutes.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer Patients
Official Title Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer
Brief Summary The aim of our study was to compare the daily living activities with a performance-based protocol in lung cancer patients and healthy controls.
Detailed Description

Lung cancer is the abnormal proliferation of cells in the lung tissue and a mass in the lung. The primary symptoms of this health problem include cough, dyspnea, chest pain, hemoptysis and sputum. In addition to these symptoms, muscle strength, respiratory function and effort level are decreased.

Inadequate daily living activities in cancer patients are expressed.But studies evaluating the activities of daily living in patients with lung cancer are inadequate and patients are evaluated only using scales. For the measurement of functional status in daily living activities, these scales provide important information about the detection of symptoms and the progression of the disease. However, it is very difficult to determine the limitation of perceived difficulty in daily living activities with these scales. In addition, since these scales are a method of measurement, the objectivity is open to discussion. It is thought that a performance-based protocol will facilitate the detection of limitations and provide more objective findings. We think that the Londrina protocol fully reflects the activities of daily living and thus will give us an objective measurement.

This study will show us the problem and its cause in daily life activities in patients with lung cancer.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals who are diagnosed with Lung Cancer at Hacettepe University and who reffered to the Cardiopulmonary Rehabilitation Unit for Physiotherapy also who are willing to participate in the study will be included in the study.
Condition Lung Cancer
Intervention Not Provided
Study Groups/Cohorts
  • lung cancer
  • healthy control group
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 Enrolling by invitation
Estimated Enrollment
 (submitted: March 18, 2019)
44
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 17, 2020
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • To have a diagnosis of lung cancer
  • Complete chemotherapy
  • Complete radiotherapy
  • Coopere,
  • Accepts participation in the study will be included in the study

Exclusion Criteria:

  • Neurological, cognitive or orthopedic diseases that affect the measurements
  • Acute infection
  • Individuals with other chronic diseases that may affect their walking will not be included in the study
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03881046
Other Study ID Numbers GO 18/737-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Hamide Sahin, Hacettepe University
Study Sponsor Hacettepe University
Collaborators Not Provided
Investigators Not Provided
PRS Account Hacettepe University
Verification Date March 2019