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OpenTrials
Completed

NCT Number: NCT06036173

Body Awareness and Functionality in Lymphedema

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.

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Key information

Conditions

Lymphedema of Upper Limb

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Selcuk University

Konya, Selcuklu, 42130, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnosis of lymphedema

Other

being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association

breast cancer surgery

Other

be diagnosed and undergo surgery

Primary outcomes

  1. Body Awareness Questionnaire

    Time frame: 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

  2. Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Effects of Lymphedema After Breast Cancer Treatment on Body Awareness and Upper Extremity Functionality

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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