Lung NeoplasmNCT04431921
Assessment of Functional Capacity, Pain, Cognitive and Respiratory Functions in Lung Cancer Survivors
An observational study of Lung Neoplasm and Survivorship, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Serious side effects occurs with disease and treatments in survival after lung cancer. For this reason, functional capacity, cognitive status, pain perception and respiratory functions may be affected in lung cancer. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasm, Survivorship
- What is being tested?
- Functional capacity
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2017to 1 Jun 2018
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lung cancer patients -> patients who were not under active cancer treatments Healthy -> No lung disease and systemic disease that affected outcome measure
Who may be able to join
- Cooperation
- lung cancer patients who had a stable condition
Who cannot join
- Active cancer treatments
- Brain metastasis story
- Any orthopedic disease impairs walking, balance
Trial locations and contacts
1 site in 1 country.
About this study
Serious side effects occurs with disease and treatments in survival after lung cancer. For this reason, functional capacity, cognitive status, pain perception and respiratory functions may be affected in lung cancer. The purpose of this study was to evaluate respiratory function, respiratory muscle strength and endurance, functional capacity, pain, cognitive status level, and physical activity in lung cancer patients and compare with the findings of healthy subjects
Read the detailed description
This study was participated lung cancer patients survivors. Patients' pulmonary function test, functional capacity, respiratory muscle strength and endurance, pain and cognitive status was assessed and recorded.
Pulmonary function testing (PFT), mouth pressure measurement (MIP- maximal inspiratory pressure and MEP- maximal expiratory pressure), respiratory muscle endurance test, six minute walk test (6MWT) and pain threshold and tolerance test were used. In addition to physiological measurements, the Montreal Cognitive Assessment (MoCA) scale was used to evaluate cognitive status, the International Physical Activity Questionnaire (IPAQ) was used to determine the level of physical activity.
- Conditions
- Lung Neoplasm, Survivorship
- Being tested
- Functional capacity
- Keywords
- Respiratory muscles, Pain, Cognitive dysfunction
- Medical subject headings
- Lung Neoplasms, Pain, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional capacityDiagnostic test
Also called Exercise capacity
Six minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer patients | Lung cancer survivors who had stable conditions and routine follow-up at Hacettepe University Oncology Hospital Receives: Diagnostic Test: Functional capacity | |
| Healthy subjects | No health problems related or affect outcome measure parameters examined in this study. Receives: Diagnostic Test: Functional capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Six minute walk test: Distance walked in six minute was recorded
Measured: 15 minutes
Secondary outcomes (7)
Respiratory muscle strength assessment
Respiratory muscle strength was evaluated by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Measured: 10 minutes
Respiratory muscle endurance
Pressure time unit: A constant load test was used to evaluate respiratory muscle endurance. Using a PowerBreathe device (HaB International Ltd., Southam, UK), the participants were asked to breathe maintaining a constant threshold (60% of MIP) until task failure, and the test duration was recorded. Results were obtained by multiplying the set pressure by the test duration
Measured: 10 minutes
Pulmonary functions test
pulmonary functions assessment via spirometry
Measured: 15 minutes
Cognition using MoCA-Test
Cognitive function was evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool. Higher scores mean a better outcome.
Measured: 10 minutes
Pressure pain threshold assessment
Pressure pain threshold was evaluated via algometer. The pressure at which the individual first reported pain was recorded.
Measured: 15 minute
Pressure pain tolerance assessment
Pressure pain tolerance test was evaluated via algometer.The pressure at which the individual last pressure point at which they could endure the pain was recorded.
Measured: 15 minute
Physical activity level
International Physical Activity Questionnaire-Short Form
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start17 Jul 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Kılıç, Hacettepe University
- Investigators
- Naciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityDeniz Inal-Ince, Professor, Study chair, Hacettepe UniversityMelda Saglam, PhD, Study chair, Hacettepe UniversityEbru Calik-Kütükcü, PhD, Study chair, Hacettepe UniversityHulya Arikan, Professor, Study chair, Hacettepe UniversitySaadettin Kilickap, Professor, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431921
- Sponsor's protocol ID
- GO17/555
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Capacity, Pain, Cognitive and Respiratory Functions in Lung Cancer Survivors
- ClinicalTrials.gov ID
- NCT04431921
- Acronym / sponsor ID
- GO17/555
- Conditions
- Lung Neoplasm, Survivorship
- Keywords
- Respiratory muscles, Pain, Cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 16 Jun 2020 (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.
Serious side effects occurs with disease and treatments in survival after lung cancer. For this reason, functional capacity, cognitive status, pain perception and respiratory functions may be affected in lung cancer. The purpose of this study was to evaluate respiratory function, respiratory muscle strength and endurance, functional capacity, pain, cognitive status level, and physical activity in lung cancer patients and compare with the findings of healthy subjects
Detailed description
This study was participated lung cancer patients survivors. Patients' pulmonary function test, functional capacity, respiratory muscle strength and endurance, pain and cognitive status was assessed and recorded.
Pulmonary function testing (PFT), mouth pressure measurement (MIP- maximal inspiratory pressure and MEP- maximal expiratory pressure), respiratory muscle endurance test, six minute walk test (6MWT) and pain threshold and tolerance test were used. In addition to physiological measurements, the Montreal Cognitive Assessment (MoCA) scale was used to evaluate cognitive status, the International Physical Activity Questionnaire (IPAQ) was used to determine the level of physical activity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer patients | – | Diagnostic Test: Functional capacityLung cancer survivors who had stable conditions and routine follow-up at Hacettepe University Oncology Hospital |
| Healthy subjects | – | Diagnostic Test: Functional capacityNo health problems related or affect outcome measure parameters examined in this study. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients -> patients who were not under active cancer treatments Healthy -> No lung disease and systemic disease that affected outcome measure
Key inclusion criteria (2 listed)
- Cooperation
- lung cancer patients who had a stable condition
Key exclusion criteria (3 listed)
- Active cancer treatments
- Brain metastasis story
- Any orthopedic disease impairs walking, balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional capacityAlso: Exercise capacitySix minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed. | Diagnostic test | Healthy subjects, Lung cancer patients |
Primary outcome
Functional capacity
Time frame: 15 minutes
Six minute walk test: Distance walked in six minute was recorded
7 secondary outcomes
Respiratory muscle strength assessment
Time frame: 10 minutes
Respiratory muscle endurance
Time frame: 10 minutes
Pulmonary functions test
Time frame: 15 minutes
Cognition using MoCA-Test
Time frame: 10 minutes
Pressure pain threshold assessment
Time frame: 15 minute
Pressure pain tolerance assessment
Time frame: 15 minute
Physical activity level
Time frame: 5 minutes
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 16 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Deniz Inal-Ince, Professor study chair
Hacettepe University
Melda Saglam, PhD study chair
Hacettepe 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 Lung Neoplasm and Survivorship, 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 2 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 16 Jun 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 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?
Functional capacity (time frame: 15 minutes). 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 16 Jun 2020.