CClinicalTrials.gg
CompletedNCT06018051Updated Jul 8, 2025

"Can Do" Versus "Do Do" in Patients With Breast Cancer

An observational study in Breast Cancer, Exercise Capacity and Physical Activity, sponsored by Hacettepe University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
59
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

Thanks to the increasing treatment possibilities with the developing technology in recent years, the majority of patients show good functional recovery after breast cancer. However, it has been reported that treatments negatively affect the functional capacity of the upper extremities, daily life, work and social activities and decrease the quality of life. Many side effects are observed in patients after breast cancer treatment. Therefore, there are various rehabilitation needs. Side effects vary from person to person. Therefore, the rehabilitation program to be applied should be personalized. Commonly reported side effects of the disease or treatments include pain, lymphedema, fatigue and depression. In addition, psychosocial consequences and psychological distress, such as reduced health-related quality of life and reduced social contacts, as well as difficulties in maintaining functional activities and life roles, have been reported. As a result, breast cancer patients may have physical, psychological, social and existential rehabilitation needs.

Exercise is an effective non-pharmacologic treatment method in cancer patients. Exercise also has therapeutic properties in cancer-related fatigue. Increased physical activity has been reported to improve psychological recovery and physical well-being in cancer patients. Aerobic exercise has been proven to reduce cancer-related fatigue as a result of studies. It has also been reported that supervised exercise during chemotherapy or radiotherapy treatments both increases the effectiveness of the treatment and reduces the side effects that may occur. In addition, resistance exercises significantly reduce cancer-related fatigue. There is evidence that there is a strong relationship between the risk of breast cancer and physical activity level. Exercise training is an important physiotherapy and rehabilitation approach in breast cancer survivors. According to randomized controlled trials on the outcomes of exercise modalities in women with breast cancer, women who exercise have improved survival rates. Physical and psychological conditions such as fatigue, pain, anxiety, depression and decreased functional capacity reduce patients' quality of life. Exercise interventions during or after treatment have been reported to improve musculoskeletal performance, cardiorespiratory fitness, body awareness, and psychological status in breast cancer. Previous studies have also reported that exercise training programs to be applied during or after cancer treatment in cancer patients improve quality of life. It has been reported that mind-body togetherness exercises such as aerobic, resistance, stretching, yoga, and Tai Chi in breast cancer patients improve quality of life and general and mental health, and have a positive effect on of the maximal oxygen uptake (VO2 max) , and provide significant improvements in self-esteem and attitude towards life. In addition, exercise training alleviates symptoms of depression and anxiety in breast cancer survivors. In addition to reducing body mass index (BMI) and causing significant increases in lean mass, exercise also increases muscle strength in the intervention groups. Furthermore, the serum concentration of some physiological markers, such as insulin, insulin-like growth factor (IGF-II) and insulin-like growth factor binding protein (IGFBP-1), is significantly reduced after the exercise intervention. Physical activity has been shown to improve the symptom of fatigue.

The type, intensity, intensity and duration of the exercise to be applied differ from person to person. Exercise intervention is safe both during and after systemic treatments. Therefore, exercise intervention should be prescribed to breast cancer patients and they should be encouraged to maintain their established exercise habits or adopt a correct type of exercise.

The most widely accepted exercise regimen for breast cancer patients is about 150 minutes of moderate to vigorous intensity aerobic exercise per week. However, only 30% to 47% of breast cancer survivors are reported to adhere to the recommended exercise programs. Furthermore, aerobic exercise, strengthening exercises or body-mind exercises have a significant impact on side effects after cancer treatments. Aerobic and resistance exercises reduce physical and psychosocial problems associated with cancer and cancer treatment. Breast cancer survivors are also recommended mindfulness, yoga or body-mind exercises to feel better and more relaxed. Breathing exercises during physical activity are important for relaxation.

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 investigators 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.

02

Conditions studied

  • Breast Cancer
  • Exercise Capacity
  • Physical Activity

Keywords

  • breast cancer
  • Quality of life.
  • exercise
  • physical activity
  • Physical capacity
03

In context

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 59 is below the median of 184 across 2,643 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Presence of active infection,
  2. Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
  3. Have a neurological disease or other clinical diagnosis that may affect cognitive status.
  4. Musculoskeletal and neurologic disease, symptomatic heart disease, previous lung surgery and malignant disease that may affect exercise performance.
  5. Presence of unstable hypertension or diabetes mellitus
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
59 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Functional Exercise Capacity

    Six-minute walk test (6MWT)

    Time frame: One Year

  2. Physical Activity Level

    SenseWear Armband (SWA)

    Time frame: One Year

Secondary outcomes

  1. Comorbidity Assessment

    The Charlson Comorbidity Index According to this index developed by the Institute of Medicine, comorbid diseases are assessed according to their severity. is scored. Comorbidities are scored from mild disease state to severe disease state. are given a score of 1, 2, 3, 4, respectively, and the score obtained by summing the scores of comorbid diseases The severity of comorbidity is also calculated according to the weighted score. One point for every ten years over the age of forty (50-59: 1 point, 60-69: 2 points, etc.)

    Time frame: One Year

  2. Peripheral muscle strength assessment

    Peripheral muscle strength (knee extensors, shoulder abductors and hand grip strength) will be measured using a handheld digital dynamometer

    Time frame: One Year

  3. Evaluation of Upper Extremity Functionality

    Questionnaire Disability of Arm, Shoulder and Hand (Q-DASH) Each item is scored on a 5-point Likert scale (1-5).The maximum score is 100 points. Score increase shows an increase in disability

    Time frame: One Year

  4. Fatigue Assessment

    Piper Fatigue Scale (PFS) Responses for each item It is evaluated between 0-10 points. The total fatigue score is based on 22 items scores are summed and divided by the number of items. Scale obtained from high scores indicate a high level of perceived fatigue shows.

    Time frame: One Year

  5. Evaluation of Quality of Life

    European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) All scores were linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score

    Time frame: One Year

07

Study locations

1 site
  • Ebru Çalık Kutukcu
    Ankara, Hacettepe Unıversity 06100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06018051
Lead sponsor
Hacettepe University
Responsible party
Ebru Calik Kutukcu (Associate Professor, Hacettepe University) — Principal investigator
First posted
Aug 30, 2023
Start date
Jun 15, 2024
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025
Last update
Jul 8, 2025

Study contacts

Ebru Calik-Kutukcu, PhD
principal investigator · Hacettepe University
Melda Saglam, PhD
study chair · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion