Breast Cancer FemaleNCT07133087
Body Awareness, Upper Extremity Function, and Quality of Life in Breast Cancer Survivors
An observational study of Breast Cancer Female, run by Halic University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 May 2025to 15 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- Willingness to participate in the study voluntarily
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Halic University
Istanbul
Seda Saka, phd, 00905447803417, sedasaka@halic.edu.tr
Dilek Şahinoğlu, dileksahinoglu@halic.edu.tr
- Recruiting
Yeditepe Hospital
Istanbul
DİLEK ŞAHİNOĞLU, PhD, 05059594487, fztdilektemel@gmail.com
About this study
Official title: Body Awareness, Upper Extremity Function, and Quality of Life in Breast Cancer Survivors: A Case-Control Study
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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: At the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start6 May 2025
- Primary completion21 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seda Saka, PhD, Study director, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133087
- Sponsor's protocol ID
- ssaka10
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Awareness, Upper Extremity Function, and Quality of Life in Breast Cancer Survivors: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07133087
- Acronym / sponsor ID
- ssaka10
- Conditions
- Breast Cancer Female
- Keywords
- breast cancer, body awareness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 21 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Having a history of neuromuscular dysfunction
- Using medications that may affect neuromuscular performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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."
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.
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
Related trials for Breast Cancer Female
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruiting
Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
No Evidence of Disease, BRCA1 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seda Saka, PhD study director
Haliç University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Halic University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seda Saka, PhD (05447803417, sedasaka@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Awareness Scale (time frame: At the day of enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.