Breast Cancer SurgeryNCT04979715
The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions
A study testing physitherapy follow-up in people with Breast Cancer Surgery, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
At least 42 patients between the ages of 30-65, who were followed up in Pamukkale University General Surgery Breast Polyclinic and planned for breast surgery, will be included in the study. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Cancer Surgery
- What is being tested?
- physitherapy follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 19 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a breast surgery indication with a diagnosis of breast cancer
- Having stage 1-2-3 breast cancer
- Education level to be at least literate
- To be in stable clinical condition
- Not having any other disease that will affect their physical and psychosocial functions
- Being good at cooperation
- Referred by the relevant surgeon and no contraindications for early postoperative physiotherapy
Who cannot join
- History of previous breast cancer surgery
- Concurrent bilateral breast cancer and/or surgery
- History of shoulder surgery
- Preoperative shoulder dysfunction
- Upper extremity deep vein thrombosis
- BMI>40 kg/m²
Show all 10Show fewer
- Use of an assistive walking device
- Stage 4 metastatic cancer
- All conditions that require close monitoring during exercise (such as uncontrolled or unstable cardiovascular disease or diabetes)
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
At least 42 patients between the ages of 30-65, who were followed up in Pamukkale University General Surgery Breast Polyclinic and planned for breast surgery, will be included in the study. Those who met the criteria for inclusion in the study and those who voluntarily agreed to participate in the study, who were preoperatively evaluated, will be randomly divided into two groups using the closed envelope method by matching age, gender, type of surgery and breast cancer stage. The first of these groups is the study (n=21) and the second is the control group (n=21).
Read the detailed description
Study group: Patients in the study group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. After obtaining the consent of the surgeon performing the operation, preoperative and post-operative complications (infection, lymphedema, fatigue…) and the things to be considered (use of upper extremities, skin care, importance of weight control…) and patient education will be given by the physiotherapist. In addition, respiratory control, diaphragmatic breathing, relaxation exercises, gradual passive-active assistive-active range of motion exercises, stretching exercises will also be demonstrated preoperatively.
From the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital.
At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging…) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants.
Participants will continue the exercises as a home program after discharge. During this follow-up period, the participants will meet again with the physiotherapist every two weeks for the control, compliance and continuity of the exercises. In these interviews, while compliance with the exercise program is checked, exercise tolerance will also be determined and necessary interventions and modifications will be made. In case of any complication (limitation in physical functions, lymphedema…) during the home program, he will be informed about meeting with the relevant physician and physiotherapist as soon as possible.
Control group: The patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given.
Written consent of all participants was obtained; demographic information will be recorded, and their physical and psychosocial conditions will be evaluated. Circumference measurements for lymphedema The extremity volume will be calculated using the Frustum formula. Modified Constant Murley Score for shoulder and upper extremity loss of function and evaluation of activities of daily living, pectoralis major and pectoralis minor shortness tests, Tanita for body composition determination, L-Dex score for bioimpedance analysis, Functional Evaluation of Breast Cancer Treatment for functional status ( Functional Assessment of Cancer Therapy -Breast Cancer - FACT-B scale, Cancer Fatigue Scale for fatigue, 6 Minute Walk Test (6MWT) for cardiovascular endurance and Hospital Anxiety and Depression Scale (HAD) for psychosocial status will be used. All measurements will be repeated preoperatively (at least 3 days before the operation), on the 1st postoperative day and 3 months later.
- Conditions
- Breast Cancer Surgery
- Being tested
- physitherapy follow-up, control
- Keywords
- breast cancer, physical functions, psychosocial functions, breast cancer physiotherapy, breast cancer survival, breast cancer surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physitherapy follow-upProcedure or surgery
preoperative patient informaiton, information leaflet and Physiotherapy meeting will be held every 2 weeks for 3 months
controlOther
no intervention; preoperative patient informaiton and information leaflet
| Study group | Role | What they receive |
|---|---|---|
| intervention group (Group 1) | Experimental | From the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital.
At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging…) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants. Receives: Procedure: physitherapy follow-up |
| control group (Group 2) | Active comparator | The patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given. Receives: Other: control |
| routine follow-up (Group 3) | No intervention | only preoperative patient information is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of limb volume changes
The circumference measurements for lymphedema will be calculated using the Frustum formula. calculations will compare with operated and non-operated limb, and also subsequent measurements. A volume increase of >200 ml is interpreted as the onset of lymphedema.
Measured: postoperative to 3 months later
determination of shoulder and upper extremity functions
Modified Constant Murley Score for assessment of shoulder and upper extremity functions. high score indicates good function.
Measured: postoperative to 3 months later
muscle shortness test
Pectoralis major and pectoralis minor muscle shortness tests.measurements will compare with operated and non-operated limb, and also subsequent.
Measured: postoperative to 3 months later
Bioimpedance analysis for body composition determination; weight
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body weight (kg), muscle mass (kg), estimated bone ratio (kg).
Measured: postoperative to 3 months later
Bioimpedance analysis for body composition determination;body mass index
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body mass index (kg/m2).
Measured: postoperative to 3 months later
Bioimpedance analysis for body composition determination; body fat and water percentage
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body fat percentage, body water percentage.
Measured: postoperative to 3 months later
Bioimpedance analysis for body composition determination; visceral fat level
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; visceral fat level.
Measured: postoperative to 3 months later
Bioimpedance analysis for body composition determination; energy consumption
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; total daily energy consumption (kcal/day).
Measured: postoperative to 3 months later
Bioimpedance analysis for body composition determination; metabolic age
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; metabolic age (years).
Measured: postoperative to 3 months later
determination of subdermal fluid ratio
Moisturemeter compactD for measurement of subdermal fluid ratio. Measurements will be compared with the subsequent.
Measured: postoperative to 3 months later
assesment of fatigue
Cancer Fatigue Scale for assesment of fatigue. A low score indicates a low fatigue rate.
Measured: postoperative to 3 months later
determination of cardiovascular endurance
6 Minute Walk Test (6MWT) will be used for cardiovascular endurance.Changes of >35 m are significant changes.
Measured: postoperative to 3 months later
Secondary outcomes (2)
determination of emotional status
It is expected that the psychosocial functions that have decreased due to breast cancer will be restored in a short time with physiotherapy follow-up and improvement of physical functions. Hospital Anxiety and Depression Scale (HAD) will be used for psychosocial status. A low score indicates low anxiety and depression.
Measured: baseline to 3 months later
Determination of quality of life
Functional Assessment of Cancer Therapy -Breast Cancer (FACT-B) scale for assessment of functional status and activities of daily living. high score indicates good function.
Measured: postoperative to 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jul 2020
- Primary completion19 Dec 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention (Group 1), control (Group 2) and routine follow-up (Group 3) groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATİYE KAŞ ÖZDEMİR, Pamukkale University
- Investigators
- Sevda YILMAZ, dr, Study chair, Pamukkale UniversityHande ŞENOL, dr, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979715
- Sponsor's protocol ID
- 2019SABE028
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kas Ozdemi̇r A, Telli Atalay O, Yilmaz S, Senol H. The effects of early rehabilitation on physical and psychosocial functions after breast cancer surgery. Support Care Cancer. 2025 Sep 23;33(10):872. doi: 10.1007/s00520-025-09926-4.
PubMed 40987957
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Rehabilitation After Breast Cancer Surgery on Physical and Psychosocial Functions
- ClinicalTrials.gov ID
- NCT04979715
- Acronym / sponsor ID
- 2019SABE028
- Conditions
- Breast Cancer Surgery
- Keywords
- breast cancer, physical functions, psychosocial functions, breast cancer physiotherapy, breast cancer survival, breast cancer surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At least 42 patients between the ages of 30-65, who were followed up in Pamukkale University General Surgery Breast Polyclinic and planned for breast surgery, will be included in the study. Those who met the criteria for inclusion in the study and those who voluntarily agreed to participate in the study, who were preoperatively evaluated, will be randomly divided into two groups using the closed envelope method by matching age, gender, type of surgery and breast cancer stage. The first of these groups is the study (n=21) and the second is the control group (n=21).
Detailed description
Study group: Patients in the study group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. After obtaining the consent of the surgeon performing the operation, preoperative and post-operative complications (infection, lymphedema, fatigue…) and the things to be considered (use of upper extremities, skin care, importance of weight control…) and patient education will be given by the physiotherapist. In addition, respiratory control, diaphragmatic breathing, relaxation exercises, gradual passive-active assistive-active range of motion exercises, stretching exercises will also be demonstrated preoperatively.
From the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital.
At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging…) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants.
Participants will continue the exercises as a home program after discharge. During this follow-up period, the participants will meet again with the physiotherapist every two weeks for the control, compliance and continuity of the exercises. In these interviews, while compliance with the exercise program is checked, exercise tolerance will also be determined and necessary interventions and modifications will be made. In case of any complication (limitation in physical functions, lymphedema…) during the home program, he will be informed about meeting with the relevant physician and physiotherapist as soon as possible.
Control group: The patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given.
Written consent of all participants was obtained; demographic information will be recorded, and their physical and psychosocial conditions will be evaluated. Circumference measurements for lymphedema The extremity volume will be calculated using the Frustum formula. Modified Constant Murley Score for shoulder and upper extremity loss of function and evaluation of activities of daily living, pectoralis major and pectoralis minor shortness tests, Tanita for body composition determination, L-Dex score for bioimpedance analysis, Functional Evaluation of Breast Cancer Treatment for functional status ( Functional Assessment of Cancer Therapy -Breast Cancer - FACT-B scale, Cancer Fatigue Scale for fatigue, 6 Minute Walk Test (6MWT) for cardiovascular endurance and Hospital Anxiety and Depression Scale (HAD) for psychosocial status will be used. All measurements will be repeated preoperatively (at least 3 days before the operation), on the 1st postoperative day and 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- intervention (Group 1), control (Group 2) and routine follow-up (Group 3) groups
| Arm | Type | Receives |
|---|---|---|
| intervention group (Group 1) | Experimental | Procedure: physitherapy follow-upFrom the first postoperative day, with the approval of the surgeon performing the operation, the postoperative exercise program will be started once a day under the supervision of a physiotherapist during the stay of the participants in the hospital. At the same time, participants will be directed to moderate intensity aerobic exercise (walking, jogging…) for 150 min/week. Information will be given on the importance of physical activity and increasing the level of physical activity. In addition, a brochure containing explanatory information about the postoperative physiotherapy program after breast surgery will be given to the participants. |
| control group (Group 2) | Active comparator | Other: controlThe patients in the control group will be informed about the postoperative physiotherapy program and patient education will be provided by the physiotherapist before the operation. Within the knowledge and approval of the surgeon performing the operation, preoperatively, respiratory control, diaphragmatic breathing, relaxation exercises, passive-active assistive-active range of motion exercises are shown by the physiotherapist, and patient education is provided with information about possible postoperative complications and what needs to be considered. will be given. |
| routine follow-up (Group 3) | No intervention | –only preoperative patient information is given. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having a breast surgery indication with a diagnosis of breast cancer
- Having stage 1-2-3 breast cancer
- Education level to be at least literate
- To be in stable clinical condition
- Not having any other disease that will affect their physical and psychosocial functions
Key exclusion criteria (10 listed)
- History of previous breast cancer surgery
- Concurrent bilateral breast cancer and/or surgery
- History of shoulder surgery
- Preoperative shoulder dysfunction
- Upper extremity deep vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physitherapy follow-uppreoperative patient informaiton, information leaflet and Physiotherapy meeting will be held every 2 weeks for 3 months | Procedure or surgery | intervention group (Group 1) |
| controlno intervention; preoperative patient informaiton and information leaflet | Other | control group (Group 2) |
Primary outcome
determination of limb volume changes
Time frame: postoperative to 3 months later
The circumference measurements for lymphedema will be calculated using the Frustum formula. calculations will compare with operated and non-operated limb, and also subsequent measurements. A volume increase of >200 ml is interpreted as the onset of lymphedema.
determination of shoulder and upper extremity functions
Time frame: postoperative to 3 months later
Modified Constant Murley Score for assessment of shoulder and upper extremity functions. high score indicates good function.
muscle shortness test
Time frame: postoperative to 3 months later
Pectoralis major and pectoralis minor muscle shortness tests.measurements will compare with operated and non-operated limb, and also subsequent.
Bioimpedance analysis for body composition determination; weight
Time frame: postoperative to 3 months later
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body weight (kg), muscle mass (kg), estimated bone ratio (kg).
Bioimpedance analysis for body composition determination;body mass index
Time frame: postoperative to 3 months later
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body mass index (kg/m2).
Bioimpedance analysis for body composition determination; body fat and water percentage
Time frame: postoperative to 3 months later
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; body fat percentage, body water percentage.
Bioimpedance analysis for body composition determination; visceral fat level
Time frame: postoperative to 3 months later
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; visceral fat level.
Bioimpedance analysis for body composition determination; energy consumption
Time frame: postoperative to 3 months later
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; total daily energy consumption (kcal/day).
Bioimpedance analysis for body composition determination; metabolic age
Time frame: postoperative to 3 months later
Tanita bioimpedance analysis device will be used to determine body composition. Measurements will be compared with the subsequent. bioimpedance analysis determines that; metabolic age (years).
determination of subdermal fluid ratio
Time frame: postoperative to 3 months later
Moisturemeter compactD for measurement of subdermal fluid ratio. Measurements will be compared with the subsequent.
assesment of fatigue
Time frame: postoperative to 3 months later
Cancer Fatigue Scale for assesment of fatigue. A low score indicates a low fatigue rate.
determination of cardiovascular endurance
Time frame: postoperative to 3 months later
6 Minute Walk Test (6MWT) will be used for cardiovascular endurance.Changes of >35 m are significant changes.
2 secondary outcomes
determination of emotional status
Time frame: baseline to 3 months later
Determination of quality of life
Time frame: postoperative to 3 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Derived from this study: PubMed 40987957Kas Ozdemi̇r A, Telli Atalay O, Yilmaz S, Senol H. The effects of early rehabilitation on physical and psychosocial functions after breast cancer surgery. Support Care Cancer. 2025 Sep 23;33(10):872. doi: 10.1007/s00520-025-09926-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevda YILMAZ, dr study chair
Pamukkale University
Hande ŞENOL, dr study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physitherapy follow-up in people with Breast Cancer Surgery, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of limb volume changes (time frame: postoperative to 3 months later). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.