Lung CancerNCT03881046
Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer Patients
An observational study of Lung Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 17 Jun 2020
- How long will I take part?
- 1 Day
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- To have a diagnosis of lung cancer
- Complete chemotherapy
- Complete radiotherapy
- Coopere,
- Accepts participation in the study will be included in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer
The aim of our study was to compare the daily living activities with a performance-based protocol in lung cancer patients and healthy controls.
Read the 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.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lung cancer | Not described | |
| healthy control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities Of Daily Living
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.
Measured: 1st day
Secondary outcomes (5)
Life Quality
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.
Measured: 1st Day
Peripheral Muscle Strength
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.
Measured: 1st Day
Dyspnoea
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.
Measured: 1st Day
Respiratory Functions
Respiratory functions will be measured by spirometric measurement. This measurement will give us FEV1 FVC FEV1 / FVC values.
Measured: 1st Day
Exercise Capacity
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.
Measured: 1st Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Feb 2019
- Primary completion17 Jan 2020
- Study completion17 Jun 2020
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 Hacettepe UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamide Sahin, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881046
- Sponsor's protocol ID
- GO 18/737-08
- Status last verified
- Jan 2023
- First submitted
- 15 Mar 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Evaluation Of Daily Living Activities And Quality Of Life In Lung Cancer
- ClinicalTrials.gov ID
- NCT03881046
- Acronym / sponsor ID
- GO 18/737-08
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- 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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung cancer | – | – |
| healthy control group | – | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- To have a diagnosis of lung cancer
- Complete chemotherapy
- Complete radiotherapy
- Coopere,
- Accepts participation in the study will be included in the study
Key exclusion criteria (3 listed)
- 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
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
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.
5 secondary outcomes
Life Quality
Time frame: 1st Day
Peripheral Muscle Strength
Time frame: 1st Day
Dyspnoea
Time frame: 1st Day
Respiratory Functions
Time frame: 1st Day
Exercise Capacity
Time frame: 1st 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 18 Apr 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 18 Apr 2023. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
Activities Of Daily Living (time frame: 1st day). 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 18 Apr 2023.