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Body Awareness and Functionality in Lymphedema

Sponsor
Selcuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06036173
Collaborator
(none)
102
Enrollment
1
Location
2.4
Anticipated Duration (Months)
43.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: diagnosis of lymphedema
  • Other: breast cancer surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
102 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Effects of Lymphedema After Breast Cancer Treatment on Body Awareness and Upper Extremity Functionality
Actual Study Start Date :
Aug 16, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 27, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Selcuk University Konya Selcuklu Turkey 42130

Sponsors and Collaborators

  • Selcuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emine Cihan, Assist. Prof., Selcuk University
ClinicalTrials.gov Identifier:
NCT06036173
Other Study ID Numbers:
  • 2023/09.06
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphedema

Study Results

No Results Posted as of Sep 13, 2023