Clinical trial NCT05923164: Reliability And Validity Study Of "The Evaluation Tool For Myofascial Adhesions In Patients After Breast Cancer" In Turkish Language
Official title: Reliability And Validity Study Of MAP-BC Evaluation Tool In Turkish Language To Detect Myofascial Adhesions Among Women Under Breast Cancer Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Upper Extremity Dysfunction
Tissue Adhesion
Keywords: Myofascial adhesions
Breast Cancer
POSAS
MAP-BC Evaluation Tool
myofascial dysfunction
validity and reliability study
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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?

Detailed description: Breast cancer is the most frequently diagnosed malignancy in all over the world. Breast and axillary surgery, radiotherapy, hormone therapy and chemotherapy treatments may cause upper extremity dysfunction and pain which negatively affect quality of life and daily living activities of breast cancer patients.

Lymphedema, severe pain, decreased range of motion of shoulder joint, axillary web syndrome, myofascial trigger points and myofascial adhesions are the leading causes affecting upper extremity function in patients with breast cancer.

Myofascial dysfunction presents as a problem characterized by trigger points, adhesions, and limitation of myofascial tissue and tissue gliding.

Muscle manipulation during surgery, scar tissue, soft tissue adhesions, adaptive posture development following surgery and radiotherapy induced fibrosis can cause myofascial adhesions. However, there is not sufficient research or tools for the evaluation of scar tissue and adhesions.

Detection, quantitative measurement and scoring of myofascial adhesions in upper extremity dysfunctions after breast cancer treatment are important for both developing target-oriented treatment plan and evaluation of treatment effectiveness (myofascial therapy, physical therapy modalities).

The Patient and Observer Scar Assessment Scale is an evaluation tool utilized to detect scar tissue and was shown for reliable and valid in patients who have undergone breast cancer surgery. Its reliability and validity study for Turkish population has been done earlier.

A new diagnostic method called MAP-BC (Myofascial Adhesions in Patients after Breast Cancer) has been developed to evaluate scar tissue after breast cancer treatments and to quantitatively measure myofascial adhesions. Its reliability and validity have been proven in various countries, however, it is yet to be tested in Turkey.

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.

Firstly, the original version of MAP-BC will be translated into Turkish and its semantic and conceptual equivalence will be checked. Later it will be finalized by the committee consisting of two translators and four expert physiatrists.

For intra-rater reliability, the same researcher will re-evaluate patients at 14-days intervals.

For inter-rater reliability, 2 different researchers will evaluate the first 15 patients by using the Patient and Observer Scar Assessment Scale and MAP-BC tools unaware of each other's results. If the outcome of the two researchers evaluation are found in agreement at a reliable rate, then the study will be continued by a single researcher.

The convergent validity of the Turkish version of MAP-BC will be assessed by comparing the results of Turkish version of both the Patient and Observer Scar Assessment Scale observer subscale (Patient and Observer Wound Assessment) and MAP-BC. Their correlation will be analyzed.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria :

* 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

Primary outcomes:
measure: MAP-BC Evaluation Tool
timeFrame: 11 months
measure: POSAS
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sultan 2. Abdulhamid Han Training and Research Hospital
state: Kadıköy
Study officials:
name: Yeliz Bahar Özdemir
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.