Body Awareness and Functionality in Lymphedema

September 6, 2023 updated by: Emine Cihan, Selcuk University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42130
        • Recruiting
        • Selcuk University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

being a woman and having had breast cancer surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
developed lymphedema after breast cancer surgery
Other: diagnosis of lymphedema
being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
Other: breast cancer surgery
be diagnosed and undergo surgery
did not develop lymphedema after breast cancer surgery
Other: breast cancer surgery
be diagnosed and undergo surgery
without a history of any cancer surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
17 minutes
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
11 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

October 27, 2023

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/09.06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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