AzTrials
AzTrials

Breast SurgeryNCT07154771

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

A study testing First with the arm circumference measurement tool, then with the traditional tape measure and First with the traditional tape measure , then with the arm circumference measurement tool in people with Breast Surgery and Breast Cancer, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Surgery, Breast Cancer, Lymphedema
What is being tested?
First with the arm circumference measurement tool, then with the traditional tape measure and First with the traditional tape measure , then with the arm circumference measurement tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jul 2025to 20 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gülhane Training and Research Hospital, University of Health Sciences

    Ankara

Other trials in Turkey (Türkiye)

About this study

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?

Read more

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.

Being tested
First with the arm circumference measurement tool, then with the traditional tape measure, First with the traditional tape measure , then with the arm circumference measurement tool
Keywords
breast cancer, mastectomy, nursing, Lymphedema
Medical subject headings
Breast Neoplasms, Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • First with the arm circumference measurement tool, then with the traditional tape measureOther

    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 toolOther

    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.

Study groups in NCT07154771
Study groupRoleWhat they receive
İntervention-control group (Patient)OtherThe 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.
Receives: Other: First with the arm circumference measurement tool, then with the traditional tape measure
Control-Intervention Group (Patients)OtherThe 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.
Receives: Other: First with the traditional tape measure , then with the arm circumference measurement tool
Intervention-Control Group (Nurses)OtherThe 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.
Receives: Other: First with the arm circumference measurement tool, then with the traditional tape measure
Control-Intervention Group (Nurses)OtherThe 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.
Receives: Other: First with the traditional tape measure , then with the arm circumference measurement tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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)

  1. Measurement Duration

    For each participant (both nurse and patient), the duration of each measurement-performed on both the right and left arms using both the tape measure and the arm circumference measurement device-will be recorded using a stopwatch. These same-day measurements will be used to compare the time efficiency and practicality of the two methods.

    Comparison will be made between the two methods in terms of time efficiency and practicality.

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

  2. User Satisfaction - Visual Analog Scale (VAS)

    Nurses' and patients' satisfaction with each measurement method will be assessed using a Visual Analog Scale ranging from 0 (not satisfied at all) to 10 (completely satisfied).

    Differences in satisfaction between methods and arms will be analyzed.

    Measured: 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)

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

    Satisfaction with the new measurement device will be evaluated using the standardized QUEST 2.0 questionnaire, which assesses satisfaction with assistive devices and related services.

    Higher scores indicate higher levels of satisfaction.

    Administered to both nurses and patients.

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

  4. Open-ended Feedback (Interview Forms)

    Qualitative data will be collected through structured interview forms to explore the experiences, perceptions, and suggestions of nurses and patients regarding the use of the new arm circumference measurement device.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start10 Jul 2025
  3. Primary completion20 Sep 2025 (estimated)
  4. Study completion20 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154771
Sponsor's protocol ID
2025-347
Status last verified
Aug 2025
First submitted
21 Jul 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I do not intend to share individual participant data (IPD).

Publications

  • 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.

    PubMed 29397555

  • 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.

    PubMed 34441238

  • 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.

    PubMed 26437431

  • 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.

    PubMed 25085806

  • 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.

    PubMed 30062571

  • 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.

    PubMed 37329176

  • 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.

    PubMed 34065795

  • 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.

    PubMed 29191123

  • 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.

    PubMed 25563360

  • 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.

    PubMed 33221590

  • 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.

    PubMed 32442064

  • 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.

    PubMed 36821887

  • 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.

    PubMed 28740950

Questions about this trial

What is this clinical trial studying?

A study testing First with the arm circumference measurement tool, then with the traditional tape measure and First with the traditional tape measure , then with the arm circumference measurement tool in people with Breast Surgery and Breast Cancer, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 8 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Intra-rater Reliability (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154771, which also lists 24 linked publications.

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 4 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in