Breast Cancer, Breast Surgery, Lymphedema
Conditions
Keywords
breast cancer, mastectomy, nursing, Lymphedema
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.
Interventions
OTHERFirst 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.
OTHERFirst 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.
Sponsors
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both the participants (patients and nurses) and the statistician conducting the data analyses are blinded to the group assignments of the participants
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
Patients: * Patients who have undergone bilateral lymph node dissection * Patients with a prior diagnosis and treatment for breast cancer (surgery, chemotherapy, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-rater Reliability | 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 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. |
| Inter-rater Reliability | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement Duration | Preoperative period (all measurements for both arms; each method's duration recorded separately and immediately) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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: | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed