The Validity and Reliability of FIT-HaNSA in Breast Cancer Patients

NCT04795778 | Unknown

• 1 other identifier: IAyas2
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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).

  For the patient group; at least 3 months after all treatments have been completed

Study Arms (2)

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

Eligibility Criteria

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

Study Population

Breast cancer patients referred to physiotherapy and rehabilitation from Gazi University hospital

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Inci Ayas

Ankara, 06560, 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

• inci ayas

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

inci ayas

CONTACT

0 312 216 26 21; inciayass@gmail.com

ilke keser

CONTACT

0 312 216 26 21; ilkekeser@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 12, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)