NCT05258344

Brief Summary

Breast cancer is one of the most common cancers among women in the world and its incidence reaches up to 16%.Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently seen during and/or after breast cancer treatments. It has been determined that lymphedema associated with breast cancer treatment is a factor that mediates and/or exacerbates the adverse effects of breast cancer treatments on upper extremity functional capacity and quality of life of patients.It was determined that the 6 Minute Pegboard and Ring Test (6PRT) score showed a clear relationship with the upper extremity daily living activities (ADLs), and it was concluded that the 6 Minute Pegboard and Ring Test (6PRT) test could be used as an appropriate test in pulmonary rehabilitation programs to predict and show the improvement of daily living activities (ADLs). Therefore, in this study; The results to be obtained by evaluating the validity and reliability of the 6 Minute Pegboard and Ring Test (6PRT) test in breast cancer patients will increase the use of this test in both testing arm endurance and arm exercise capacity in breast cancer patients, and predicting the effect on daily living activities (ADLs)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

February 17, 2022

Last Update Submit

December 12, 2022

Conditions

Keywords

breast cancer6 Minute Pegboard and Ring TestArm exercise endurance

Outcome Measures

Primary Outcomes (1)

  • 6 minute Pegboard and Ring Test - 6PRT

    Total number of rings installed within six

    one year

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients between the ages of 18-80 who were diagnosed with breast cancer in Hacettepe University Hospital, Department of Internal Medicine, Department of Medical Oncology and volunteered to participate in the study will be included in the study.

You may qualify if:

  • To be between the ages of 18-80,
  • Volunteering to participate in the research,
  • At least 15 months after breast cancer surgery,
  • months after active breast cancer treatment (ie surgery/chemotherapy)
  • Having no problem in reading and/or understanding the scales and being able to cooperate with the tests.

You may not qualify if:

  • Presence of active infection,
  • Presence of bilateral breast cancer,
  • Presence of a history of surgical, neurological or orthopedic problems that may affect upper extremity functionality other than breast cancer surgery,
  • Having a neurological disease or other clinical diagnosis that may affect cognitive status,
  • Having musculoskeletal and neurological disease, symptomatic heart disease, previous lung surgery and malignant disease that may affect exercise performance.
  • Presence of unstable hypertension or diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ebru Calik Kutukcu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 28, 2022

Study Start

March 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations