Development and Usability Evaluation of an Arm Circumference Measurement Tool For Patients Undergoing Breast Surgery
NCT ID: NCT07154771
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
35 participants
INTERVENTIONAL
2025-07-10
2025-11-20
Brief Summary
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Is there a significant difference in intra-observer reliability between the measurements taken by nurses and patients using the arm circumference measurement device and those taken using a traditional tape measure?
Is there a significant difference in inter-observer reliability between the measurements taken by nurses and patients using the arm circumference measurement device and those taken using a traditional tape measure?
Is there a significant difference in the measurement results obtained by nurses and patients when using the arm circumference measurement device compared to a traditional tape measure?
Do nurses and patients experience a difference in the duration of arm circumference measurements when using the measurement device versus a traditional tape measure?
Is there a difference in the satisfaction levels of nurses and patients regarding arm circumference measurements performed with the measurement device versus a traditional tape measure? This study will be conducted in two phases: the first phase involves the development of the arm circumference measurement tool, and the second phase involves the evaluation of its usability through a double-blind, two-group, crossover randomized controlled trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Within this scope, the intra-observer and inter-observer reliability of the traditional tape measure and the newly developed arm circumference measurement device for measuring upper extremity circumference will be compared. In the crossover design, nurses and patients will be randomly assigned to study groups where both measurement methods will be applied in a predetermined order. There are a total of four study groups for nurses and patients, based on intervention-control and control-intervention sequences.
OTHER
DOUBLE
Study Groups
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İntervention-control group (Patient)
The intervention-control group will first perform circumference measurements using the arm circumference measurement device, followed by measurements with the tape measure. The measurement values obtained by the patients will be recorded in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration of the measurements, which will also be documented in the form.
First with the arm circumference measurement tool, then with the traditional tape measure
Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the newly developed arm circumference measurement device, followed by the traditional tape measure.
Control-Intervention Group (Patients)
The control-intervention group will first perform circumference measurements using the tape measure, followed by measurements with the arm circumference measurement device. The measurement values obtained by the patients will be recorded in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration of the measurements, which will also be documented in the form.
At the end of the procedure, all patients will complete the Visual Analog Scale (VAS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), and Patient Interview Form.
First with the traditional tape measure , then with the arm circumference measurement tool
Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the traditional tape measure, and then using the newly developed arm circumference measurement device.
Intervention-Control Group (Nurses)
The intervention-control group will first perform circumference measurements using the arm circumference measurement device, followed by measurements with the tape measure. Nurses will record their measurement values in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration, which will also be noted in the form.
First with the arm circumference measurement tool, then with the traditional tape measure
Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the newly developed arm circumference measurement device, followed by the traditional tape measure.
Control-Intervention Group (Nurses)
The control-intervention group will first perform circumference measurements using the tape measure, followed by measurements with the arm circumference measurement device. Nurses will record their measurement values in the Anthropometric Measurement and Time Tracking Form. The researcher will use a stopwatch to record the duration, which will also be noted in the form.
At the end of the procedure, all nurses will complete the Visual Analog Scale (VAS), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), and Nurse Interview Form.
First with the traditional tape measure , then with the arm circumference measurement tool
Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the traditional tape measure, and then using the newly developed arm circumference measurement device.
Interventions
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First with the arm circumference measurement tool, then with the traditional tape measure
Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the newly developed arm circumference measurement device, followed by the traditional tape measure.
First with the traditional tape measure , then with the arm circumference measurement tool
Patients and nurses in this group will measure both arms (at four different anatomical reference points) first using the traditional tape measure, and then using the newly developed arm circumference measurement device.
Eligibility Criteria
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Inclusion Criteria
-Currently working in General Surgery or Surgical Oncology clinics
Patients:
* Aged 18 years or older
* Newly diagnosed with breast cancer confirmed by histopathology
* Planned to undergo radical mastectomy, modified radical mastectomy, or breast-conserving surgery
* Scheduled for axillary lymph node dissection (at least two lymph nodes to be dissected)
* Able to understand information related to circumference measurement and perform the required skills
Exclusion Criteria
* Patients who have undergone bilateral lymph node dissection
* Patients with a prior diagnosis and treatment for breast cancer (surgery, chemotherapy, etc.)
18 Years
ALL
No
Sponsors
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Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
OTHER
Responsible Party
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Rumeysa Ozcelik
Research Assistant
Principal Investigators
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Hatice AYHAN, Professor
Role: STUDY_DIRECTOR
SBUniversite
Locations
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Gülhane Training and Research Hospital, University of Health Sciences
Ankara, , Turkey (Türkiye)
Countries
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References
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Zou L, Liu FH, Shen PP, Hu Y, Liu XQ, Xu YY, Pen QL, Wang B, Zhu YQ, Tian Y. The incidence and risk factors of related lymphedema for breast cancer survivors post-operation: a 2-year follow-up prospective cohort study. Breast Cancer. 2018 May;25(3):309-314. doi: 10.1007/s12282-018-0830-3. Epub 2018 Feb 3.
Yusof KM, Avery-Kiejda KA, Ahmad Suhaimi S, Ahmad Zamri N, Rusli MEF, Mahmud R, Saini SM, Abdul Wahhab Ibraheem S, Abdullah M, Rosli R. Assessment of Potential Risk Factors and Skin Ultrasound Presentation Associated with Breast Cancer-Related Lymphedema in Long-Term Breast Cancer Survivors. Diagnostics (Basel). 2021 Jul 21;11(8):1303. doi: 10.3390/diagnostics11081303.
Yakut, Y., Yurt, Y., Yağci, G., & Şimşek, İ. E. (2021). Quebec Yardımcı Teknoloji Kullanıcı Memnuniyeti Değerlendirme 2.0 Anketi'nin protez ve ortez kullanan bireylerde Türkçe adaptasyonu. Journal of Exercise Therapy and Rehabilitation, 7(3), 284-295. https://dergipark.org.tr/en/pub/jetr/issue/59488/706401
Turna, I. F. (2020). Lenfödem Tanı ve Tedavisine Güncel Bakış. Acibadem Universitesi Saglik Bilimleri Dergisi, 11(1), 0-0. https://doi.org/10.31067/0.2020.238
Tidhar D, Armer JM, Deutscher D, Shyu CR, Azuri J, Madsen R. Measurement Issues in Anthropometric Measures of Limb Volume Change in Persons at Risk for and Living with Lymphedema: A Reliability Study. J Pers Med. 2015 Sep 30;5(4):341-53. doi: 10.3390/jpm5040341.
Taghian NR, Miller CL, Jammallo LS, O'Toole J, Skolny MN. Lymphedema following breast cancer treatment and impact on quality of life: a review. Crit Rev Oncol Hematol. 2014 Dec;92(3):227-34. doi: 10.1016/j.critrevonc.2014.06.004. Epub 2014 Jul 2.
Sun F, Hall A, Tighe MP, Brunelle CL, Sayegh HE, Gillespie TC, Daniell KM, Taghian AG. Perometry versus simulated circumferential tape measurement for the detection of breast cancer-related lymphedema. Breast Cancer Res Treat. 2018 Nov;172(1):83-91. doi: 10.1007/s10549-018-4902-z. Epub 2018 Jul 30.
Shi B, Lin Z, Shi X, Guo P, Wang W, Qi X, Zhou C, Zhang H, Liu X, Iv A. Effects of a lymphedema prevention program based on the theory of knowledge-attitude-practice on postoperative breast cancer patients: A randomized clinical trial. Cancer Med. 2023 Jul;12(14):15468-15481. doi: 10.1002/cam4.6171. Epub 2023 Jun 17.
Pappalardo M, Starnoni M, Franceschini G, Baccarani A, De Santis G. Breast Cancer-Related Lymphedema: Recent Updates on Diagnosis, Severity and Available Treatments. J Pers Med. 2021 May 12;11(5):402. doi: 10.3390/jpm11050402.
Ostby PL, Armer JM, Smith K, Stewart BR. Patient Perceptions of Barriers to Self-Management of Breast Cancer-Related Lymphedema. West J Nurs Res. 2018 Dec;40(12):1800-1817. doi: 10.1177/0193945917744351. Epub 2017 Nov 30.
Ostby PL, Armer JM, Dale PS, Van Loo MJ, Wilbanks CL, Stewart BR. Surveillance recommendations in reducing risk of and optimally managing breast cancer-related lymphedema. J Pers Med. 2014 Aug 18;4(3):424-47. doi: 10.3390/jpm4030424.
Sheikhi-Mobarakeh Z, Yarmohammadi H, Mokhatri-Hesari P, Fahimi S, Montazeri A, Heydarirad G. Herbs as old potential treatments for lymphedema management: A systematic review. Complement Ther Med. 2020 Dec;55:102615. doi: 10.1016/j.ctim.2020.102615. Epub 2020 Nov 9.
McLaughlin SA, Brunelle CL, Taghian A. Breast Cancer-Related Lymphedema: Risk Factors, Screening, Management, and the Impact of Locoregional Treatment. J Clin Oncol. 2020 Jul 10;38(20):2341-2350. doi: 10.1200/JCO.19.02896. Epub 2020 May 22. No abstract available.
Li MM, Wu PP, Qiang WM, Li JQ, Zhu MY, Yang XL, Wang Y. Development and validation of a risk prediction model for breast cancer-related lymphedema in postoperative patients with breast cancer. Eur J Oncol Nurs. 2023 Apr;63:102258. doi: 10.1016/j.ejon.2022.102258. Epub 2022 Dec 31.
Kayiran O, De La Cruz C, Tane K, Soran A. Lymphedema: From diagnosis to treatment. Turk J Surg. 2017 Jun 1;33(2):51-57. doi: 10.5152/turkjsurg.2017.3870. eCollection 2017.
Harrington S, Gilchrist L, Sander A. Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain. Rehabil Oncol. 2014;32(1):13-21.
Hameeteman M, Verhulst AC, Vreeken RD, Maal TJ, Ulrich DJ. 3D stereophotogrammetry in upper-extremity lymphedema: An accurate diagnostic method. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):241-7. doi: 10.1016/j.bjps.2015.10.011. Epub 2015 Oct 22.
Gandhi A, Xu T, DeSnyder SM, Smith GL, Lin R, Barcenas CH, Stauder MC, Hoffman KE, Strom EA, Ferguson S, Smith BD, Woodward WA, Perkins GH, Mitchell MP, Garner D, Goodman CR, Aldrich M, Travis M, Lilly S, Bedrosian I, Shaitelman SF. Prospective, early longitudinal assessment of lymphedema-related quality of life among patients with locally advanced breast cancer: The foundation for building a patient-centered screening program. Breast. 2023 Apr;68:205-215. doi: 10.1016/j.breast.2023.02.011. Epub 2023 Feb 24.
Fajdic J, Djurovic D, Gotovac N, Hrgovic Z. Criteria and procedures for breast conserving surgery. Acta Inform Med. 2013 Mar;21(1):16-9. doi: 10.5455/AIM.2013.21.16-19.
Donahue PMC, MacKenzie A, Filipovic A, Koelmeyer L. Advances in the prevention and treatment of breast cancer-related lymphedema. Breast Cancer Res Treat. 2023 Jul;200(1):1-14. doi: 10.1007/s10549-023-06947-7. Epub 2023 Apr 27.
Cau N, Galli M, Cimolin V, Grossi A, Battarin I, Puleo G, Balzarini A, Caraceni A. Quantitative comparison between the laser scanner three-dimensional method and the circumferential method for evaluation of arm volume in patients with lymphedema. J Vasc Surg Venous Lymphat Disord. 2018 Jan;6(1):96-103. doi: 10.1016/j.jvsv.2017.08.014.
Boyages J, Xu Y, Kalfa S, Koelmeyer L, Parkinson B, Mackie H, Viveros H, Gollan P, Taksa L. Financial cost of lymphedema borne by women with breast cancer. Psychooncology. 2017 Jun;26(6):849-855. doi: 10.1002/pon.4239. Epub 2016 Aug 21.
Armer JM, Hulett JM, Bernas M, Ostby P, Stewart BR, Cormier JN. Best Practice Guidelines in Assessment, Risk Reduction, Management, and Surveillance for Post-Breast Cancer Lymphedema. Curr Breast Cancer Rep. 2013 Jun;5(2):134-144. doi: 10.1007/s12609-013-0105-0.
Ozhanli Y, Akyolcu N. Satisfaction of Patients with Triage and Nursing Practice in Emergency Departments. Florence Nightingale J Nurs. 2020 Mar 6;28(1):49-60. doi: 10.5152/FNJN.2020.18041. eCollection 2020 Feb.
Other Identifiers
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2025-347
Identifier Type: -
Identifier Source: org_study_id
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