NCT06251570

Brief Summary

Lung cancer is one of the most diagnosed cancer types worldwide, according to GLOBOCAN data published in 2020. According to these data, lung cancer comes second after breast cancer with 2,206,771 new diagnoses worldwide in 2020. According to Türkiye's data for 2020, 41,264 new lung cancer diagnoses made. Lung cancer tumors are divide into two main histological groups non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Current medical treatment methods for lung cancer are surgical resection, chemotherapy, radiotherapy, and targeted therapies. Cancer treatments can be administered as a combination of these methods appropriately selected for patients. Advances in treatment methods in recent years have increased survival and prolonged life expectancy. However, these treatment methods may affect patients in various areas from functional independence to quality of life. Cancer treatments can cause various cognitive impairments such as memory, executive functions, and concentration. In particular, a significant number of cancer patients receiving chemotherapy report cognitive disturbances that include attention problems, memory loss, and mixed thought processes ('chemobrain' or 'chemofog?), often accompanied by mood disorders and fatigue. Despite recent large cohort studies using neuropsychological testing and neuroimaging in cancer patients undergoing chemotherapy, it remains unclear whether cognitive deficits are due to treatment, cancer itself, and/or psychological factors. Patients with cognitive impairment due to chemotherapy reported that they had difficulty performing and completing simple tasks such as preparing meals, keeping track of bills and paying, or getting ready to go out, and needed additional time to perform these tasks. They may also find it difficult to perform necessary work-related tasks and then need to change jobs or cease employment altogether. Therefore, treatment-related cognitive impairment can have a significant impact on cognitive, occupational, and social functioning, all of which can result in significant personal problems and, in many cases, reduced quality of life. During daily activities, we often need to perform multiple tasks at the same time. These tasks are usually cognitive and motor tasks. A dual-task is the simultaneous execution of two tasks that have different objectives and can performed independently. In this case, attention should be focused on two tasks at the same time. These tasks can be measured separately. Deteriorated cognitive function due to cancer and its treatments can affect the dual-task performance of individuals in their daily lives and reduce their quality of life. Respiratory symptoms can be seen in lung cancer and post-cancer survival. Cancer itself and treatments can affect the cardiorespiratory system. Considering that the number of individuals living with lung cancer increases every year, the evaluation of dual-task performance and respiratory muscle endurance, which is related to the cognitive status of individuals, and if necessary, adding them to the rehabilitation program can reduce the symptoms of individuals and increase their quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

February 9, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 4, 2024

Last Update Submit

February 1, 2024

Conditions

Keywords

Dual-tasklung cancerrespiratory muscle endurance

Outcome Measures

Primary Outcomes (2)

  • Evaluating Dual Task Performance

    Individuals' response accuracy will be used as an outcome measure.

    10 minutes

  • Evaluation of Respiratory Muscle Endurance

    It will be done with the Power Breathe device at 60% of the maximal inspiratory pressure at a fixed threshold load and the time the patient can sustain will be recorded. The resulting measurement is the product of the test time and the pressure measurement corresponding to the test time.

    15 minutes

Secondary Outcomes (5)

  • Measurment of Tissue Oxygenation

    10 minutes

  • Measurment of Fatigue

    5 minutes

  • Measurment of Quality of Life

    5 minutes

  • Physical Activity Level

    5 minutes

  • Cognitive Function

    10 minutes

Study Arms (2)

Patients with Lung Cancer

Patients with Lung Cancer

Other: Evaluation of Dual Task Performance

Control Group

Control Group

Other: Evaluation of Dual Task Performance

Interventions

The Montreal Cognitive Evaluation Scale will be used to evaluate the cognitive functions of the participants. Evaluation of Physical Activity Level: The Turkish validity and reliability of the International Physical Activity Questionnaire Short Form made by Sağlam et al. will be used. Evaluation of Quality of Life: It will be evaluated by the European Organization for Cancer Research and Treatments QLQ-C30 questionnaire. Fatigue Evaluation: A fatigue severity scale consisting of 9 items will be used. Dyspnea Assessment: The Modified Medical Research Council Dyspnea Scale will be used. Respiratory Muscle Endurance: Evaluation will be done by respiratory muscle endurance test at constant threshold load with a Power Breathe device and according to the metronome warning and a MOXY monitor will be used. In evaluation of dual-task performance, an auditory task test will be performed while walking on the treadmill.

Also known as: Evaluation of Respiratory Muscle Endurance, Evaluation of Cognitive Function, Evaluation of Physical Activity Level, Evaluation of Quality of Life, Fatigue Evaluation, Dyspnea Assesment
Control GroupPatients with Lung Cancer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients who were diagnosed with lung cancer at Liv Hospital Ankara were included in the study. Patients between the ages of 18-65 who are willing to participate will be taken. Snowball method will be used for the control group. Volunteer relatives of the patient and the researcher, and contact with hospital staff and then with other individuals in the same way.

You may qualify if:

  • Individuals between the ages of 18-65
  • Individuals willing to participate in the research
  • Individuals diagnosed with lung cancer stage I-II-III
  • Individuals whose treatment has been completed and at least 6 months have passed since
  • Does not have any orthopedic problems that will prevent him from walking on the treadmill individuals
  • Having no problem in reading and/or understanding the scales and cooperating with the tests eligible individuals will be included in the study.
  • Individuals between the ages of 18-65
  • Individuals willing to participate in the research
  • Individuals without a diagnosis of any lung disease
  • Does not have any orthopedic problems that will prevent him from walking on the treadmill individuals
  • Having no problem in reading and/or understanding the scales and being cooperative with the tests eligible individuals will be included in the study.

You may not qualify if:

  • Individuals with the presence of metastases
  • Individuals with hearing problems
  • A neurological disease or other clinical diagnoses that may affect the cognitive status Individuals with disabilities will not be included in the study.
  • Individuals with hearing problems
  • A neurological disease or other clinical diagnoses that may affect the cognitive status Individuals with disabilities will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1563-1579. doi: 10.1158/1055-9965.EPI-19-0221.

  • Ettinger DS, Akerley W, Borghaei H, Chang AC, Cheney RT, Chirieac LR, D'Amico TA, Demmy TL, Ganti AK, Govindan R, Grannis FW Jr, Horn L, Jahan TM, Jahanzeb M, Kessinger A, Komaki R, Kong FM, Kris MG, Krug LM, Lennes IT, Loo BW Jr, Martins R, O'Malley J, Osarogiagbon RU, Otterson GA, Patel JD, Pinder-Schenck MC, Pisters KM, Reckamp K, Riely GJ, Rohren E, Swanson SJ, Wood DE, Yang SC, Hughes M, Gregory KM; NCCN (National Comprehensive Cancer Network). Non-small cell lung cancer. J Natl Compr Canc Netw. 2012 Oct 1;10(10):1236-71. doi: 10.6004/jnccn.2012.0130.

  • Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Mohile S. Exercise Recommendations for Cancer-Related Fatigue, Cognitive Impairment, Sleep problems, Depression, Pain, Anxiety, and Physical Dysfunction: A Review. Oncol Hematol Rev. 2012;8(2):81-88. doi: 10.17925/ohr.2012.08.2.81.

  • Anderson-Hanley C, Sherman ML, Riggs R, Agocha VB, Compas BE. Neuropsychological effects of treatments for adults with cancer: a meta-analysis and review of the literature. J Int Neuropsychol Soc. 2003 Nov;9(7):967-82. doi: 10.1017/S1355617703970019.

  • Falleti MG, Sanfilippo A, Maruff P, Weih L, Phillips KA. The nature and severity of cognitive impairment associated with adjuvant chemotherapy in women with breast cancer: a meta-analysis of the current literature. Brain Cogn. 2005 Oct;59(1):60-70. doi: 10.1016/j.bandc.2005.05.001. Epub 2005 Jun 21.

  • Boykoff N, Moieni M, Subramanian SK. Confronting chemobrain: an in-depth look at survivors' reports of impact on work, social networks, and health care response. J Cancer Surviv. 2009 Dec;3(4):223-32. doi: 10.1007/s11764-009-0098-x. Epub 2009 Sep 16.

  • Joly F, Giffard B, Rigal O, De Ruiter MB, Small BJ, Dubois M, LeFel J, Schagen SB, Ahles TA, Wefel JS, Vardy JL, Pancre V, Lange M, Castel H. Impact of Cancer and Its Treatments on Cognitive Function: Advances in Research From the Paris International Cognition and Cancer Task Force Symposium and Update Since 2012. J Pain Symptom Manage. 2015 Dec;50(6):830-41. doi: 10.1016/j.jpainsymman.2015.06.019. Epub 2015 Sep 5.

  • Lange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410.

  • Hodgson KD, Hutchinson AD, Wilson CJ, Nettelbeck T. A meta-analysis of the effects of chemotherapy on cognition in patients with cancer. Cancer Treat Rev. 2013 May;39(3):297-304. doi: 10.1016/j.ctrv.2012.11.001. Epub 2012 Dec 6.

  • Falbo S, Condello G, Capranica L, Forte R, Pesce C. Effects of Physical-Cognitive Dual Task Training on Executive Function and Gait Performance in Older Adults: A Randomized Controlled Trial. Biomed Res Int. 2016;2016:5812092. doi: 10.1155/2016/5812092. Epub 2016 Dec 8.

  • Hofman M, Ryan JL, Figueroa-Moseley CD, Jean-Pierre P, Morrow GR. Cancer-related fatigue: the scale of the problem. Oncologist. 2007;12 Suppl 1:4-10. doi: 10.1634/theoncologist.12-S1-4.

  • Morrow GR. Cancer-related fatigue: causes, consequences, and management. Oncologist. 2007;12 Suppl 1:1-3. doi: 10.1634/theoncologist.12-S1-1. No abstract available.

  • Cankurtaran ES, Ozalp E, Soygur H, Ozer S, Akbiyik DI, Bottomley A. Understanding the reliability and validity of the EORTC QLQ-C30 in Turkish cancer patients. Eur J Cancer Care (Engl). 2008 Jan;17(1):98-104. doi: 10.1111/j.1365-2354.2007.00827.x.

  • Gencay-Can A, Can SS. Validation of the Turkish version of the fatigue severity scale in patients with fibromyalgia. Rheumatol Int. 2012 Jan;32(1):27-31. doi: 10.1007/s00296-010-1558-3. Epub 2010 Jul 24.

  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

  • Anton HA, Miller WC, Townson AF. Measuring fatigue in persons with spinal cord injury. Arch Phys Med Rehabil. 2008 Mar;89(3):538-42. doi: 10.1016/j.apmr.2007.11.009.

  • Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017 Sep;17(8):1037-1043. doi: 10.1080/17461391.2017.1330899. Epub 2017 May 30.

  • Tomporowski PD, Audiffren M. Dual-task performance in young and older adults: speed-accuracy tradeoffs in choice responding while treadmill walking. J Aging Phys Act. 2014 Oct;22(4):557-63. doi: 10.1123/japa.2012-0241. Epub 2013 Dec 4.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

cakır

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 4, 2024

First Posted

February 9, 2024

Study Start

February 5, 2024

Primary Completion

June 15, 2024

Study Completion

July 30, 2024

Last Updated

February 9, 2024

Record last verified: 2024-01