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临床试验/NCT04795778
NCT04795778Unknown不适用

The Validity and Reliability of FIT-HaNSA (Functional Impairment Test-Hand and Neck/Shoulder/Arm) in Breast Cancer Patients

Gazi University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
FIT-HaNSA test for upper extremity performance

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those whose treatments for breast cancer have been completed 18 years and over

排除标准

  • 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.

结局指标

主要结局

FIT-HaNSA test for upper extremity performance

时间窗: 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 functionality

时间窗: 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

时间窗: 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).

Upper extremity disability

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İnci Hazal Ayas

Principal Investigator

Gazi University

研究点 (1)

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