Body Awareness, Upper Extremity Function, and Quality of Life in Breast Cancer Survivors

NCT07133087 | Recruiting

• 1 other identifier: ssaka10
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Breast cancer is one of the most common types of cancer among women and one of the leading causes of morbidity and mortality. With increasing survival rates, issues such as treatment-related morbidities and consequently upper extremity dysfunction, reduced body awareness, and decreased quality of life are frequently encountered. In the literature, the impact of treatment-related morbidities-particularly on upper extremity functions, body awareness, and quality of life-among women who have survived breast cancer treatment has not been sufficiently investigated. This gap constitutes a significant shortcoming in terms of clinical practices and the post-treatment period. This study aims to examine the effects of breast cancer treatment on upper extremity functions, body awareness, and quality of life in women who have survived breast cancer treatment, in comparison with a healthy control group. The study will be conducted at Yeditepe University Koşuyolu Hospital between May, 2025, and October, 2025. Participants will include women who have survived breast cancer treatment and a healthy control group matched based on criteria such as age and body mass index. In the study, three separate assessments will be conducted for upper extremity functions: the "Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) questionnaire for upper extremity functionality, a hand dynamometer for grip strength, and the Clinometer device for shoulder joint position sense. The "Body Awareness Questionnaire" will be used to assess body awareness, and the "EORTC QLQ-C30" scale will be used for quality of life assessment. The IBM SPSS Statistics software package will be used for data analysis. In statistical analyses, a significance level of p\<0.05 will be considered.

Conditions

Breast Cancer Female

Keywords

breast cancer; body awareness

Outcome Measures

Primary Outcomes (5)

• Body Awareness Scale

  The scale consists of 18 items evaluated on a 7-point Likert scale and aims to determine the sensitivity level of body composition through 4 subgroups. The four sub-parameters of the scale are: "Changes in Body Processes," "Sleep-Wake Cycle," "Prediction of Illness Onset," and "Prediction of Bodily Reactions."

  At the day of enrollment

• Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

  The questionnaire will be used to determine individuals' levels of functionality.

  At the day of enrollment

• Hand Grip Strength Assessment

  A Jamar Hand Dynamometer (Takei Scientific Instruments Co., Ltd - Japan) will be used to measure participants' maximum grip strength

  At the day of enrollment

• Shoulder Joint Position Sense

  Shoulder joint position sense will be assessed using the "Clinometer" smartphone application. Goniometer and inclinometer applications, adapted for both iOS and Android systems, are low-cost methods with proven validity and reliability, accessible to a wide population

  At the day of enrollment

• European Organisation for Research and Treatment of Cancer Questionnaire

  It consists of 30 items and includes three subscales for to assess disease spesific quality of life: global health status, functional status, and symptom control.

  At the day of enrollment

Study Arms (2)

Healthy control group

A group of healthy subjects, matched with the breast cancer group based on criteria such as age and body mass index, will be included in the study.

Breast cancer group

Women who have survived Stage 0-III breast cancer will be included in the study.

Eligibility Criteria

• Age: 25 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of women who have survived breast cancer treatment at Yeditepe University Koşuyolu Hospital and a healthy control group. The sample will include breast cancer survivors and healthy controls who meet the inclusion and exclusion criteria and voluntarily agree to participate in the study.

You may qualify if:

• Being a woman
• Being between the ages of 25 and 75
• Having been diagnosed with Stage 0-III breast cancer
• Having completed primary treatments (surgery, chemotherapy, and/or radiation therapy) no more than 6 months prior to the assessment date
• Having received medical clearance from a physician
• Having undergone either breast-conserving surgery or mastectomy due to breast cancer
• Willingness to participate in the study voluntarily

You may not qualify if:

• Having a history of rehabilitation due to upper extremity, thoracic, or cervical musculoskeletal disorders within 6 months prior to the breast cancer diagnosis
• Having a history of neuromuscular dysfunction
• Using medications that may affect neuromuscular performance
• Being a woman
• Having a body mass index (BMI) within ±3 kg/m² of the breast cancer survivor group
• Being within ±5 years of age compared to the breast cancer survivor group
• Matching hand dominance with the breast cancer survivor group
• Having a history of neuromuscular dysfunction
• Using medications that may affect neuromuscular performance
• Having a history of rehabilitation due to upper extremity, thoracic, or cervical musculoskeletal disorders within the last 6 months

Sponsors & Collaborators

• Halic University: lead

Study Sites (2)

Halic University

Istanbul, Turkey (Türkiye)

RECRUITING

Yeditepe Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seda Saka, PhD

  Haliç University

  STUDY DIRECTOR

Central Study Contacts

Seda Saka, PhD

CONTACT

05447803417; sedasaka@halic.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: May 6, 2025
• Primary Completion: October 21, 2025
• Study Completion: November 15, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

TU (2)