Reliability And Validity Study Of "The Evaluation Tool For Myofascial Adhesions In Patients After Breast Cancer" In Turkish Language

NCT05923164 | Unknown

• 1 other identifier: 23/337
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to translate the MAP-BC Evaluation Tool into Turkish by adapting it to Turkish society and to conduct a validity and reliability study in women who have received breast cancer treatment. The main questions it aims to answer are:

• Are the same researcher's MAP-BC Evaluation Tool results similar at intervals to detect myofascial adhesions in breast cancer patients in Turkish population?
• Are the different researchers' MAP-BC Evaluation Tool results similar to detect myofascial adhesions in breast cancer patients in Turkish population?
• After comparing the results of Turkish version of both The Patient and Observer Scar Assessment Scale Observer Subscale and MAP-BC Evaluation Tool, is there a sufficient correlation between them?

Conditions

Breast Cancer; Upper Extremity Dysfunction; Tissue Adhesion

Keywords

Myofascial adhesions; Breast Cancer; POSAS; MAP-BC Evaluation Tool; myofascial dysfunction; validity and reliability study

Outcome Measures

Primary Outcomes (2)

• MAP-BC Evaluation Tool

  This tool was developed to evaluate scar tissues that occured after breast cancer treatments. It quantitatively measures myofascial adhesions. The degree of adhesion is scored for each area at 3 different depth levels (skin, superficial, deep) as a 4-point scale (0: no adhesion - 3: severe adhesion). Axillary scar, breast/mastectomy scar, m. pectoralis region, frontal chest wall, lateral chest wall, axilla and inframammary fold are evaluated separately. Sum of the scores from three levels of each area gives the total score. The maximum score is 63. In Breast cancer patients, the inter-rater reliability of the detection of myofascial adhesions by palpation has been reported good to excellent.

  11 months

• POSAS

  This assesment tool consists of two different scales evaluated by the observer and the patient. Its validity and reliability have been proven for the detection of scar tissue in patients who have undergone breast cancer surgery. The observer scale rates five variables, which include vascularity, pigmentation, thickness, relief, pliability and surface area, between 1-10 points (1:normal skin). The total score ranges from 5 to 50. The Turkish version of POSAS, whose validity and reliability studies were conducted, will be used in our study.

  11 months

Study Arms (1)

Breast Cancer Patients

Patients who had undergone breast cancer surgery, aged between 18-75 years-old

Diagnostic Test: MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation Tool; Diagnostic Test: Patient And Observer Scar Assessment Scale ( Observer Subscale)

Interventions

MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation Tool DIAGNOSTIC_TEST

It's a tool to evaluate scar tissues that occured after breast cancer treatment. It quantitatively measures myofascial adhesions. The degree of adhesion is scored for each area at 3 different depth levels (skin, superficial, deep) as a 4-point scale (0: no adhesion - 3: severe adhesion). Axillary scar, breast/mastectomy scar, m. pectoralis region, frontal chest wall, lateral chest wall, axilla and inframammary fold are evaluated separately. Sum of the scores from three levels of each area gives the total score. The minimal total score is: 0 and the maximum total score is 63.

Breast Cancer Patients

Patient And Observer Scar Assessment Scale ( Observer Subscale) DIAGNOSTIC_TEST

This assesment tool consists of two different scales evaluated by the observer and the patient.The observer scale rates five variables, which include vascularity, pigmentation, thickness, relief, pliability and surface area, between 1-10 points (1:normal skin). The total score ranges from 5 to 50.

Breast Cancer Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female Gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients, aged between 18-75 years, who have undergone breast cancer surgery, visiting our oncological rehabilitation outpatient clinic between August 2023 and March 2024

You may qualify if:

• Breast cancer patients aged between 18-75 years who had undergone breast surgery
• providing a written consent to participate in the study

You may not qualify if:

• Patients who do not agree to participate the study
• Patients with active skin disease/infection which limits physical examination (palpation)
• Patients with a secondary breast cancer and/or metastasis

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Kadıköy, Turkey (Türkiye)

Location

Related Publications (7)

• Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.

  PMID: 17230080 BACKGROUND

• Lewit K, Olsanska S. Clinical importance of active scars: abnormal scars as a cause of myofascial pain. J Manipulative Physiol Ther. 2004 Jul-Aug;27(6):399-402. doi: 10.1016/j.jmpt.2004.05.004.

  PMID: 15319762 BACKGROUND

• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

  PMID: 15804318 BACKGROUND

• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

  PMID: 11124735 BACKGROUND

• De Groef A, Van der Gucht E, Dams L, Evenepoel M, Teppers L, Toppet-Hoegars J, De Baets L. The association between upper limb function and variables at the different domains of the international classification of functioning, disability and health in women after breast cancer surgery: a systematic review. Disabil Rehabil. 2022 Apr;44(8):1176-1189. doi: 10.1080/09638288.2020.1800835. Epub 2020 Aug 8.

  PMID: 32772650 BACKGROUND

• Seyyah M, Yurdalan SU. Cultural adaptation and validation of Patient and Observer Scar Assessment Scale for Turkish use. Burns. 2018 Aug;44(5):1352-1356. doi: 10.1016/j.burns.2018.02.026. Epub 2018 Mar 24.

  PMID: 29580666 BACKGROUND

• De Groef A, Van Kampen M, Vervloesem N, De Geyter S, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. An evaluation tool for myofascial adhesions in patients after breast cancer (MAP-BC evaluation tool): Development and interrater reliability. PLoS One. 2017 Jun 9;12(6):e0179116. doi: 10.1371/journal.pone.0179116. eCollection 2017.

  PMID: 28598978 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Tissue Adhesions

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yeliz Bahar Özdemir

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özden Tömek, MD

CONTACT

Turkey: +905343284941; ozden.tomek@gmail.com

Gökçenur Yalçın, MD

CONTACT

+905301413290; gokce_cihaner@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: August 30, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

TU (1)