NCT06036173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

September 6, 2023

Last Update Submit

November 8, 2023

Conditions

Lymphedema of Upper Limb

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

developed lymphedema after breast cancer surgery

Other: diagnosis of lymphedemaOther: breast cancer surgery

did not develop lymphedema after breast cancer surgery

Other: breast cancer surgery

without a history of any cancer surgery

Interventions

diagnosis of lymphedemaOTHER

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

developed lymphedema after breast cancer surgery
breast cancer surgeryOTHER

be diagnosed and undergo surgery

developed lymphedema after breast cancer surgerydid not develop lymphedema after breast cancer surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

being a woman and having had breast cancer surgery

You may qualify if:

  • 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.
  • without lymphedema were being female,
  • being aged 18-65 years,
  • having undergone unilateral breast cancer surgery, and volunteering to participate in the study.
  • being female,
  • being aged 18-65 years,
  • having no history of cancer surgery, and volunteering to participate in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

August 16, 2023

Primary Completion

September 30, 2023

Study Completion

October 27, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

TU(1)