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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06036173
Other study ID # 2023/09.06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 16, 2023
Est. completion date October 27, 2023

Study information

Verified date November 2023
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date October 27, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: first group: - being female, - being aged 18-65 years, - having undergone unilateral breast cancer surgery, - being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association - not having any orthopedic disease that would prevent walking, and volunteering to participate in the study. second group:The inclusion criteria for the breast cancer surgery group - without lymphedema were being female, - being aged 18-65 years, - having undergone unilateral breast cancer surgery, and volunteering to participate in the study. Lastly, the inclusion criteria for the control group were: - being female, - being aged 18-65 years, - having no history of cancer surgery, and volunteering to participate in the study. Exclusion Criteria: for all groups - not being willing to participate in the study; - the presence of metastases, neurological, or orthopedic disorders; - postural deformities, such as scoliosis and kyphosis; - mental and cognitive disorders; or communication/cooperation problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
diagnosis of lymphedema
being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
breast cancer surgery
be diagnosed and undergo surgery

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Awareness Questionnaire This instrument consists of a total of 18 items evaluated based on a scale of 1 (not at all true of me) to 7 (very true of me). The total score is obtained by adding the scores of each item. A higher total score indicates better body awareness. Max/ min score:126/18 17 minutes
Primary Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire Each of the 11 items in this instrument is scored from 1 to 5. The responses given to all items are summed up, and the total score is obtained with a special formula. A high total score indicates a high level of functional limitation. Max/ min score: 100/0 11 minutes
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