Breast CancerNCT04795778
The Validity and Reliability of FIT-HaNSA in Breast Cancer Patients
An observational study of Breast Cancer and FIT-HaNSA, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common type of cancer among women and covers 25% of all cancers. After mastectomy and reconstruction, many patients develop various upper extremity complications such as joint movement limitation, pain, lymphedema, and axillary cord. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, FIT-HaNSA, Upper Extremity Dysfunction
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients referred to physiotherapy and rehabilitation from Gazi University hospital
Who may be able to join
- Those whose treatments for breast cancer have been completed 18 years and over
Who cannot join
- Have a history of upper extremity surgery, excluding breast cancer surgery Have a history of upper extremity trauma Those who have orthopedic, neurological, rheumatological or cognitive impairments that may interfere with the application of the test.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inci Ayas
Ankara, 06560
inci ayas, 0 312 216 26 21, inciayass@gmail.com
ilke keser, 0 312 216 26 21, ilkekeser@yahoo.com
About this study
Official title: The Validity and Reliability of FIT-HaNSA (Functional Impairment Test-Hand and Neck/Shoulder/Arm) in Breast Cancer Patients
Breast cancer is the most common type of cancer among women and covers 25% of all cancers. After mastectomy and reconstruction, many patients develop various upper extremity complications such as joint movement limitation, pain, lymphedema, and axillary cord. Because of such upper extremity problems, evaluation and treatment of upper extremity functions are important. Upper extremity functions are generally evaluated with questionnaires filled out by the patients themselves and which reflect their own perspectives subjectively. However, these questionnaires cannot reflect the observations and evaluations of the clinicians. Performance tests are important for clinicians to make decisions.
With this study, we want to examine the usability of the FIT-HaNSA test in the evaluation of upper extremity functions in patients with breast cancer. Our hypothesis; The FıtHaNSA test is successful in evaluating the upper extremity function in patients with breast cancer.
- Conditions
- Breast Cancer, FIT-HaNSA, Upper Extremity Dysfunction
- Keywords
- Breast Cancer, FIT-HaNSA, Upper Extremity Dysfunction
- 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 |
|---|---|---|
| Patients with breast cancer | Breast cancer patients with or without breast cancer surgery, with or without mastectomy, with or without lymphedema | |
| Control group | Healty individuals with no disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT-HaNSA test for upper extremity performance
FIT-HaNSA protocol includes 3 steps.In the first step of the test 3 weights of 1kg are placed on the shelf at the waist level of the individual at 10 cm intervals.The person moves these weights in rows to the 25 cm upper rack and then place them back on the lower rack.The person is asked to continue this process for 5 minutes.In the second step of the test, the first shelf is placed at eye level, the second shelf is placed 25 cm below it and the procedures in the first step are repeated.In the 3rd step, a wooden plate with 3 holes is placed perpendicular to the shelf at eye level of the individual.The hole in the middle is left empty by placing nuts and bolts in the first and third holes before. The individual must return to the starting point in order by attaching the bolt in the first hole to the second hole, the bolt in the third hole to the first hole and finally the bolt in the second hole to the third hole and this process is 5 minutes.
Measured: For the patient group; at least 3 months after all treatments have been completed
Upper extremity disability
Upper extremity disability will be evaluated with DASH questionnaire (Disabilities of the Arm, Shoulder and Hand). It is a questionnaire consisting of 30 questions that evaluates the dysfunctions of the entire upper extremity. It consists of questions evaluating the degree of difficulty in performing different activities using the upper extremity in daily life (21 questions), pain, numbness, joint stiffness and weakness symptoms (5 questions), social life, sleep, work and psychological status (4 questions) in the last week.
Measured: For the patient group; at least 3 months after all treatments have been completed
Upper extremity functionality
Upper extremity functionality will be evaluated with Upper Extremity Functional Index (UEFI). It is a questionnaire consisting of 20 questions that questions the functional difficulty of the upper extremity in daily life activities. Each question is scored between 0 and 4 (0: extremely difficult, 4: no difficulty).
Measured: For the patient group; at least 3 months after all treatments have been completed
Shoulder disability
Shoulder disability will be evaluated with Shoulder Pain and Disabilty Index (SPADI). The scale, which consists of 13 questions in total, has two subsections as pain and disability. The pain section consists of 5 questions describing the pain of the patient, and the disability section consists of 8 questions that indicate the degree of difficulty experienced when using the upper extremity. Each question is scored from 0 to 10 (0 is no difficulty, 10 is very difficult).
Measured: For the patient group; at least 3 months after all treatments have been completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- inci ayas, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795778
- Sponsor's protocol ID
- IAyas2
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only study officials will be able to view patient data The statistical analysis will also be done by the study officials.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of FIT-HaNSA (Functional Impairment Test-Hand and Neck/Shoulder/Arm) in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04795778
- Acronym / sponsor ID
- IAyas2
- Conditions
- Breast Cancer, FIT-HaNSA, Upper Extremity Dysfunction
- Keywords
- Breast Cancer, FIT-HaNSA, Upper Extremity Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Mar 2021 (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 the most common type of cancer among women and covers 25% of all cancers. After mastectomy and reconstruction, many patients develop various upper extremity complications such as joint movement limitation, pain, lymphedema, and axillary cord. Because of such upper extremity problems, evaluation and treatment of upper extremity functions are important. Upper extremity functions are generally evaluated with questionnaires filled out by the patients themselves and which reflect their own perspectives subjectively. However, these questionnaires cannot reflect the observations and evaluations of the clinicians. Performance tests are important for clinicians to make decisions.
With this study, we want to examine the usability of the FIT-HaNSA test in the evaluation of upper extremity functions in patients with breast cancer. Our hypothesis; The FıtHaNSA test is successful in evaluating the upper extremity function in patients with breast cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer | – | –Breast cancer patients with or without breast cancer surgery, with or without mastectomy, with or without lymphedema |
| Control group | – | –Healty individuals with no disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients referred to physiotherapy and rehabilitation from Gazi University hospital
Key inclusion criteria (1 listed)
- Those whose treatments for breast cancer have been completed 18 years and over
Key exclusion criteria (1 listed)
- Have a history of upper extremity surgery, excluding breast cancer surgery Have a history of upper extremity trauma Those who have orthopedic, neurological, rheumatological or cognitive impairments that may interfere with the application of the test.
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
FIT-HaNSA test for upper extremity performance
Time frame: For the patient group; at least 3 months after all treatments have been completed
FIT-HaNSA protocol includes 3 steps.In the first step of the test 3 weights of 1kg are placed on the shelf at the waist level of the individual at 10 cm intervals.The person moves these weights in rows to the 25 cm upper rack and then place them back on the lower rack.The person is asked to continue this process for 5 minutes.In the second step of the test, the first shelf is placed at eye level, the second shelf is placed 25 cm below it and the procedures in the first step are repeated.In the 3rd step, a wooden plate with 3 holes is placed perpendicular to the shelf at eye level of the individual.The hole in the middle is left empty by placing nuts and bolts in the first and third holes before. The individual must return to the starting point in order by attaching the bolt in the first hole to the second hole, the bolt in the third hole to the first hole and finally the bolt in the second hole to the third hole and this process is 5 minutes.
Upper extremity disability
Time frame: For the patient group; at least 3 months after all treatments have been completed
Upper extremity disability will be evaluated with DASH questionnaire (Disabilities of the Arm, Shoulder and Hand). It is a questionnaire consisting of 30 questions that evaluates the dysfunctions of the entire upper extremity. It consists of questions evaluating the degree of difficulty in performing different activities using the upper extremity in daily life (21 questions), pain, numbness, joint stiffness and weakness symptoms (5 questions), social life, sleep, work and psychological status (4 questions) in the last week.
Upper extremity functionality
Time frame: For the patient group; at least 3 months after all treatments have been completed
Upper extremity functionality will be evaluated with Upper Extremity Functional Index (UEFI). It is a questionnaire consisting of 20 questions that questions the functional difficulty of the upper extremity in daily life activities. Each question is scored between 0 and 4 (0: extremely difficult, 4: no difficulty).
Shoulder disability
Time frame: For the patient group; at least 3 months after all treatments have been completed
Shoulder disability will be evaluated with Shoulder Pain and Disabilty Index (SPADI). The scale, which consists of 13 questions in total, has two subsections as pain and disability. The pain section consists of 5 questions describing the pain of the patient, and the disability section consists of 8 questions that indicate the degree of difficulty experienced when using the upper extremity. Each question is scored from 0 to 10 (0 is no difficulty, 10 is very difficult).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No. Only study officials will be able to view patient data The statistical analysis will also be done by the study officials.
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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. This study is not recruiting at the moment.
inci ayas study director
Gazi University
1 site 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 and FIT-HaNSA, run by Gazi University at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact inci ayas (0 312 216 26 21, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIT-HaNSA test for upper extremity performance (time frame: For the patient group; at least 3 months after all treatments have been completed). The study lists 4 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 12 Mar 2021.