Body Awareness and Functionality in Lymphedema

Completed

• Conditions: Lymphedema of Upper Limb
• Interventions: Other: diagnosis of lymphedema; Other: breast cancer surgery

• Registration Number: NCT06036173
• Lead Sponsor: Selcuk University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-16
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
developed lymphedema after breast cancer surgery	breast cancer surgery	-
did not develop lymphedema after breast cancer surgery	breast cancer surgery	-
developed lymphedema after breast cancer surgery	diagnosis of lymphedema	-

Primary Outcome Measures

Name	Time	Method
Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire	11 minutes	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
Body Awareness Questionnaire	17 minutes	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

Trial Locations

Locations (1)

Selcuk University; 🇹🇷 Konya, Selcuklu, Turkey