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

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04795778
Collaborator
(none)
30
1
19
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Validity and Reliability of FIT-HaNSA (Functional Impairment Test-Hand and Neck/Shoulder/Arm) in Breast Cancer Patients
    Actual Study Start Date :
    Feb 1, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. FIT-HaNSA test for upper extremity performance [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.

    2. Upper extremity disability [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.

    3. Upper extremity functionality [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).

    4. Shoulder disability [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Those whose treatments for breast cancer have been completed 18 years and over
    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inci Ayas Ankara Turkey 06560

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Study Director: inci ayas, Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    İnci Hazal Ayas, Principal Investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT04795778
    Other Study ID Numbers:
    • IAyas2
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Mar 12, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by İnci Hazal Ayas, Principal Investigator, Gazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 12, 2021