NCT04431921

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 10, 2020

Last Update Submit

June 11, 2020

Conditions

Lung NeoplasmSurvivorship

Keywords

Respiratory musclesPainCognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Functional capacity

    Six minute walk test: Distance walked in six minute was recorded

    15 minutes

Secondary Outcomes (7)

  • Respiratory muscle strength assessment

    10 minutes

  • Respiratory muscle endurance

    10 minutes

  • Pulmonary functions test

    15 minutes

  • Cognition using MoCA-Test

    10 minutes

  • Pressure pain threshold assessment

    15 minute

  • +2 more secondary outcomes

Study Arms (2)

Lung cancer patients

Lung cancer survivors who had stable conditions and routine follow-up at Hacettepe University Oncology Hospital

Diagnostic Test: Functional capacity

Healthy subjects

No health problems related or affect outcome measure parameters examined in this study.

Diagnostic Test: Functional capacity

Interventions

Functional capacityDIAGNOSTIC_TEST

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.

Also known as: Exercise capacity
Healthy subjectsLung cancer patients

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Lung cancer patients -\> patients who were not under active cancer treatments Healthy -\> No lung disease and systemic disease that affected outcome measure

You may qualify if:

  • Cooperation
  • lung cancer patients who had a stable condition

You may not qualify if:

  • Active cancer treatments
  • Brain metastasis story
  • Any orthopedic disease impairs walking, balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung NeoplasmsPainCognitive Dysfunction

Interventions

Functional Residual Capacity

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Total Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR

  • Deniz Inal-Ince, Professor

    Hacettepe University

    STUDY CHAIR

  • Melda Saglam, PhD

    Hacettepe University

    STUDY CHAIR

  • Ebru Calik-Kütükcü, PhD

    Hacettepe University

    STUDY CHAIR

  • Hulya Arikan, Professor

    Hacettepe University

    STUDY CHAIR

  • Saadettin Kilickap, Professor

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 16, 2020

Study Start

July 17, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

TU(1)