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Clinical Trials/NCT05303675
NCT05303675
Completed
Not Applicable

The Effect of Education, Lymphedema Risk Scoring, and Progressive Upper Extremity Exercises on Strengthening the Self-care Skills of Women Who Have Breast Cancer Surgery

Gulseren MARAS1 site in 1 country40 target enrollmentApril 18, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Gulseren MARAS
Enrollment
40
Locations
1
Primary Endpoint
self-care
Status
Completed
Last Updated
last year

Overview

Brief Summary

In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.

Registry
clinicaltrials.gov
Start Date
April 18, 2022
End Date
October 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Gulseren MARAS
Responsible Party
Sponsor Investigator
Principal Investigator

Gulseren MARAS

Research Assistant

TC Erciyes University

Eligibility Criteria

Inclusion Criteria

  • Female gender,
  • Between 18-65 years old
  • BMI ≤30 kg/m2
  • Axillary lymph node dissection (removal of at least 2 lymph nodes),
  • No history of cancer other than breast cancer,
  • Does not have any chronic disease (such as diabetes mellitus, hypertension, chronic obstructive pulmonary disease) that prevents exercise
  • No previous diagnosis of lymphedema,
  • Not pregnant or breastfeeding during the study,
  • Individuals who agree to participate in the study will be included in the study.

Exclusion Criteria

  • Total (simple) mastectomy,
  • History of bilateral lymph node dissection,
  • Lymphedema (difference \>2 cm with an intact extremity)
  • Individuals who do not agree to participate in the study will not be included in the study.

Outcomes

Primary Outcomes

self-care

Time Frame: 3rd month

The number of participants with a high self-care score according to the 'Breast Cancer-Related Lymphedema Self-Care Scale'. 'Breast Cancer-Related Lymphedema Self-Care Scale': The lowest 31, the highest 124 points are taken from the scale. Higher scores indicate better self-care.

lymphedema symptom

Time Frame: 3rd month

Change from baseline in the number of lymphedema symptoms according to the 'Symptom Warning Model For Lymphedema' at 3-month. 'Symptom Warning Model For Lymphedema':The model consists of 17 symptoms and Yes/No response components. Patients with less than 15% of 17 symptoms are defined as low risk, 15-49% at medium risk, and patients with more than 50% symptoms are defined as high risk.

arm circumference measurement

Time Frame: 3nd month

Change from baseline in arm circumference at 3 month. Arm circumference measurement: An increase of 1 cm or more in the circumference of the affected arm compared to the healthy side and an increase of 2 cm or more for late detection of lymphedema indicates the presence of lymphedema.

Study Sites (1)

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