Development and Usability Evaluation of an Arm Circumference Measurement Tool For Patients Undergoing Breast Surgery

NCT07154771 | Active Not Recruiting

• 1 other identifier: 2025-347
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to develop an arm circumference measurement device that can be used by both patients and nurses in the follow-up of upper extremity lymphedema, which may occur as a result of breast cancer surgery, and to evaluate its usability. This study also seeks to determine whether the developed device can offer a more accurate, faster, and more practical alternative compared to traditional tape measurements. The main questions it aims to answer are: 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.

Conditions

Breast Surgery; Breast Cancer; Lymphedema

Keywords

breast cancer; mastectomy; nursing; Lymphedema

Outcome Measures

Primary Outcomes (2)

• Intra-rater Reliability

  The consistency of repeated measurements performed by the same individual (nurse, patient, or researcher) using different methods (tape measure and the newly developed arm circumference measurement device). Evaluated separately for the right and left arms. Comparisons will be made between the two measurement methods.

  Preoperative period (Same day, within 30 minutes between repeated measurements.) The same rater (nurse/patient/researcher) performs repeated measurements on the same arm with both methods within a short interval to assess consistency.

• Inter-rater Reliability

  The agreement between different raters (nurse-patient, nurse-researcher, patient-researcher) using the same method (either tape measure or the new measurement device). Evaluated for both arms and both measurement tools. Inter-rater agreement will be assessed across all rater combinations.

  Preoperative period (Same day, sequential measurements within 1 hour by different raters.) Measurements by different raters (nurse, patient, researcher) are conducted on the same day in a fixed sequence.

Secondary Outcomes (4)

• Measurement Duration

  Preoperative period (all measurements for both arms; each method's duration recorded separately and immediately)

• User Satisfaction - Visual Analog Scale (VAS)

  Preoperative period (each participant completes both measurement methods; immediately after finishing all measurements for both arms, the participant completes the same-day questionnaire without delay)

• User Satisfaction - Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

  Preoperative period (questionnaire completed immediately after all measurements on both arms using both methods)

• Open-ended Feedback (Interview Forms)

  Preoperative period (open-ended feedback collected immediately after completing both measurement methods and satisfaction scales during the same session) Türkçe:

Study Arms (4)

İntervention-control group (Patient)

OTHER

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.

Other: First with the arm circumference measurement tool, then with the traditional tape measure

Control-Intervention Group (Patients)

OTHER

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.

Other: First with the traditional tape measure , then with the arm circumference measurement tool

Intervention-Control Group (Nurses)

OTHER

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.

Other: First with the arm circumference measurement tool, then with the traditional tape measure

Control-Intervention Group (Nurses)

OTHER

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.

Other: First with the traditional tape measure , then with the arm circumference measurement tool

Interventions

First with the arm circumference measurement tool, then with the traditional tape measure OTHER

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.

Intervention-Control Group (Nurses); İntervention-control group (Patient)

First with the traditional tape measure , then with the arm circumference measurement tool OTHER

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.

Control-Intervention Group (Nurses); Control-Intervention Group (Patients)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since the study focuses on breast cancer, which is the most common cancer type among women worldwide, patient participants are required to be female. However, nurse participants can be of any gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nurses:
• 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

You may not qualify if:

• Patients:
• Patients who have undergone bilateral lymph node dissection
• Patients with a prior diagnosis and treatment for breast cancer (surgery, chemotherapy, etc.)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Gülhane Training and Research Hospital, University of Health Sciences

Ankara, Turkey (Türkiye)

Location

Related Publications (24)

• 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.

  PMID: 29397555 BACKGROUND

• 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.

  PMID: 34441238 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26437431 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

  PMID: 29191123 BACKGROUND

• 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.

  PMID: 25563360 BACKGROUND

• 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.

  PMID: 33221590 BACKGROUND

• 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.

  PMID: 32442064 BACKGROUND

• 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.

  PMID: 36821887 BACKGROUND

• 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.

  PMID: 28740950 BACKGROUND

• Harrington S, Gilchrist L, Sander A. Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain. Rehabil Oncol. 2014;32(1):13-21.

  PMID: 25346950 BACKGROUND

• 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.

  PMID: 26590631 BACKGROUND

• 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.

  PMID: 36863241 BACKGROUND

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MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hatice AYHAN, Professor

  SBUniversite

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the participants (patients and nurses) and the statistician conducting the data analyses are blinded to the group assignments of the participants
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This study will be conducted in two phases: the first phase involves the development of the arm circumference measurement device, and the second phase consists of a two-group crossover randomized controlled trial to evaluate the usability of the developed device. 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.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 4, 2025
• Study Start: July 10, 2025
• Primary Completion: September 20, 2025
• Study Completion: November 20, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)