Trial Title:
"Can Do" Versus "Do Do" in Patients With Breast Cancer
NCT ID:
NCT06018051
Condition:
Breast Cancer
Exercise Capacity
Physical Activity
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
Quality of life.
exercise
physical activity
Physical capacity
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ebru Çalık Kutukcu
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Start date:
June 15, 2024
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Hacettepe University
Agency class:
Other
Source:
Hacettepe University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06018051
