NCT06018051

Brief Summary

Breast cancer occurs as a result of uncontrolled proliferation of cells in the breast tissue. Breast cancer is the most common type of cancer among women worldwide and is an important problem that threatens women's lives. The incidence rate has reached approximately 16 Breast cancer treatment consists of local and systemic therapies. While local treatments include surgery and radiotherapy, systemic treatments, which are administered in two different ways, namely adjuvant and neoadjuvant systemic treatments, consist of chemotherapy, hormone therapy and targeted biological therapies. Although the treatment options for breast cancer are increasing day by day, there are many complications during and after treatment. These complications negatively affect functionality and quality of life The 6-minute walk test (6MWD) is a widely used test for indirect measurement of cardiorespiratory fitness in various cancer populations. Studies have proven that the 6MWT is safe and feasible in breast cancer patients. The concept of 'can do, do do' has recently emerged to describe impaired physical functions in chronic obstructive pulmonary disease (COPD) and asthma. This concept categorizes participants into four quadrants based on physical activity level and functional capacity measurements and cut-off point. This concept has proven useful for measuring physical function in both asthma and COPD. This concept may be useful in understanding physical functioning in breast cancer patients. Therefore, The aim of this study is to apply the concept of 'can do, do do' in breast cancer patients, to determine the quadrants according to physical activity level and functional capacity measurements in breast cancer patients, to investigate whether and to what extent there is a difference, whether and to what extent there is a difference between demographic information, disease stages, comorbidity level, clinical features, peripheral muscle strength, fatigue and quality of life and upper extremity functionality according to quadrants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

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

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

August 24, 2023

Last Update Submit

July 2, 2025

Conditions

Keywords

breast cancerQuality of life.exercisephysical activityPhysical capacity

Outcome Measures

Primary Outcomes (2)

  • Functional Exercise Capacity

    Six-minute walk test (6MWT)

    One Year

  • Physical Activity Level

    SenseWear Armband (SWA)

    One Year

Secondary Outcomes (5)

  • Comorbidity Assessment

    One Year

  • Peripheral muscle strength assessment

    One Year

  • Evaluation of Upper Extremity Functionality

    One Year

  • Fatigue Assessment

    One Year

  • Evaluation of Quality of Life

    One Year

Eligibility Criteria

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

Patients between the ages of 18-65 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:

  • Being between 18-65 years of age,
  • Volunteering to participate in the research,
  • At least 15 months after breast cancer surgery,
  • Six months after active breast cancer treatment (i.e. surgery/chemotherapy),
  • No problems in reading and/or understanding the scales and being able to cooperate with the tests,

You may not qualify if:

  • Presence of active infection,
  • Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
  • Have a neurological disease or other clinical diagnosis that may affect cognitive status.
  • Musculoskeletal and neurologic 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)

Ebru Çalık Kutukcu

Ankara, Hacettepe Unıversity, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Ebru Calik-Kutukcu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Melda Saglam, PhD

    Hacettepe University

    STUDY CHAIR

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

August 24, 2023

First Posted

August 30, 2023

Study Start

June 15, 2024

Primary Completion

June 12, 2025

Study Completion

June 12, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations