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NCT Number: NCT07133087

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

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Halic University, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for breast cancer survivors:

  • 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

Exclusion criteria

for breast cancer survivors:

  • 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

Inclusion criteria

for the control group:

  • 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

Exclusion criteria

for the control 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

Treatment and study plan

Primary outcomes

  1. Body Awareness Scale

    Time frame: At the day of enrollment

    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."

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

    Time frame: At the day of enrollment

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

  3. Hand Grip Strength Assessment

    Time frame: At the day of enrollment

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

  4. Shoulder Joint Position Sense

    Time frame: At the day of enrollment

    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

  5. European Organisation for Research and Treatment of Cancer Questionnaire

    Time frame: At the day of enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seda Saka, PhD

CONTACT

[email protected]

05447803417

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Official study title

Body Awareness, Upper Extremity Function, and Quality of Life in Breast Cancer Survivors: A Case-Control Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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