Breast CancerNCT05950685
Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments
An observational study of Breast Cancer, run by Ifat Klein at 1 site in Israel.
Trial summary
Background: Breast cancer (BC) treatments usually include a combination of surgery, chemotherapy and radiation. These life-saving treatments cause high percentages of arm morbidity, which often lasts for months, or develops months after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,602 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2023to 1 Jun 2025
- Phase
- Observational
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patient six months till three years after surgery
Who may be able to join
- Patients aged 18-75
- Independent
- Speaking Hebrew and Russian
Who cannot join
- Patients who reported that from the time elapsed from the surgery they underwent additional surgery or an injury affecting the function/ pain of the arm.
- Patients suffering from advanced metastatic disease, or background diseases that limit function.
- Lymphedema prior to surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Screening Tool for Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments
Background: Breast cancer (BC) treatments usually include a combination of surgery, chemotherapy and radiation. These life-saving treatments cause high percentages of arm morbidity, which often lasts for months, or develops months after surgery. Arm and shoulder morbidity includes prolonged pain, restriction of movement, limitation of function and lymphedema (chronic progressive edema). All of these morbidities affect the quality of life (QOL) of the recovering patients and require lengthy care. Early detection of patients at risk and provision of proactive treatment can improve the recovery process from surgery and oncology treatments.
Aim: To develop a screening tool for the early identification of women at high risk for prolonged arm morbidity following BC treatments (persistent pain, lymphedema, function deficits and decreased range of motion), validate the tool, and examine the efficiency of intervention based on the the use of the tool.
Read the detailed description
The development and the assessment of the screening tool will conduct in three stages:
- Systematic review and meta-analysis to identify from the literature risk factors for lymphedema, prolong pain, decreased range of motion (ROM), quality of life (QOL) and function after breast cancer (BC) treatments and surgery. Intended to understand which factor could be included in the screening tool.
- Development of the screening tool (study no. 1)- cross section study that will examine which of the risk factors found in the literature review/ meta-analysis will enter the tool. Women up to 3 years after BC surgery will be evaluated for arm morbidity (pain, lymphedema, limitation of movement and limitation of function), and their association to the risk factors, using an online questionnaire.
- A small cohort study (study no. 2)- Aimed to validate the screening tool. The study will be conducted at the hospital's oncology institute, and will recruit BC survivors who come for routine follow-up six months till three years after surgery. Patients will be asked to answer an online questionnaire, in addition, limb volume tests, strength and ROM will be performed at the clinic. A comparison will be made between the physical parameters that indicate the morbidity of the arm and the score found in the screening tool.
- A small prospective study (study no. 3)- The main goal of this study is to examine whether the use of the new questionnaire by the patients themselves will; A) affect the percentage of arrival to physical therapy (PT) treatments, B) will affect morbidity rates.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH questionnaire
a shortened version of the The Disabilities of the Arm, Shoulder and Hand (DASH), that contains 11 items measuring an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to her severity/function level. The the scores range from 0 (no disability) to 100 (most severe disability).
Measured: 18 months
Numeric pain rating scale
Pain scale reported by patients with rage of 0(no pain)-10(the worst possible pain imaginable).
Measured: 18 months
The Godin-Shephard Leisure-Time Physical Activity
divides the effort levels into light/ mild, moderate, strenuous and multiply by time per week.
Measured: 18 months
Secondary outcomes (2)
Number of patients diagnosed with lymphedema
Diagnosis of lymphedema by a doctor / physical therapist
Measured: 18 months
Shoulder range of motion
Using DR Goniometer App evaluating ranges of motion in degrees between 0 (no range) to 180 (full range)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jan 2023
- Primary completion1 May 2025
- Study completion1 Jun 2025
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 CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ifat Klein
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor-investigator, Ifat Klein, Assuta Medical Center
- Investigators
- Merav Ben- David, Professor, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950685
- Sponsor's protocol ID
- 0019-22ASMC
- Status last verified
- Jul 2024
- First submitted
- 19 Mar 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Klein I, Susmallian S. Long-Term Shoulder Dysfunction After Breast and Axillary Surgery: Impact of Surgical Extent and Predictors of Function. ANZ J Surg. 2026 May 19. doi: 10.1111/ans.70745. Online ahead of print.
PubMed 42157559
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Screening Tool for Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments
- ClinicalTrials.gov ID
- NCT05950685
- Acronym / sponsor ID
- 0019-22ASMC
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,602 participants (actual)
- Lead sponsor
- Ifat KleinUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 18 Jul 2023 (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.
Background: Breast cancer (BC) treatments usually include a combination of surgery, chemotherapy and radiation. These life-saving treatments cause high percentages of arm morbidity, which often lasts for months, or develops months after surgery. Arm and shoulder morbidity includes prolonged pain, restriction of movement, limitation of function and lymphedema (chronic progressive edema). All of these morbidities affect the quality of life (QOL) of the recovering patients and require lengthy care. Early detection of patients at risk and provision of proactive treatment can improve the recovery process from surgery and oncology treatments.
Aim: To develop a screening tool for the early identification of women at high risk for prolonged arm morbidity following BC treatments (persistent pain, lymphedema, function deficits and decreased range of motion), validate the tool, and examine the efficiency of intervention based on the the use of the tool.
Detailed description
The development and the assessment of the screening tool will conduct in three stages:
- Systematic review and meta-analysis to identify from the literature risk factors for lymphedema, prolong pain, decreased range of motion (ROM), quality of life (QOL) and function after breast cancer (BC) treatments and surgery. Intended to understand which factor could be included in the screening tool.
- Development of the screening tool (study no. 1)- cross section study that will examine which of the risk factors found in the literature review/ meta-analysis will enter the tool. Women up to 3 years after BC surgery will be evaluated for arm morbidity (pain, lymphedema, limitation of movement and limitation of function), and their association to the risk factors, using an online questionnaire.
- A small cohort study (study no. 2)- Aimed to validate the screening tool. The study will be conducted at the hospital's oncology institute, and will recruit BC survivors who come for routine follow-up six months till three years after surgery. Patients will be asked to answer an online questionnaire, in addition, limb volume tests, strength and ROM will be performed at the clinic. A comparison will be made between the physical parameters that indicate the morbidity of the arm and the score found in the screening tool.
- A small prospective study (study no. 3)- The main goal of this study is to examine whether the use of the new questionnaire by the patients themselves will; A) affect the percentage of arrival to physical therapy (PT) treatments, B) will affect morbidity rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patient six months till three years after surgery
Key inclusion criteria (3 listed)
- Patients aged 18-75
- Independent
- Speaking Hebrew and Russian
Key exclusion criteria (3 listed)
- Patients who reported that from the time elapsed from the surgery they underwent additional surgery or an injury affecting the function/ pain of the arm.
- Patients suffering from advanced metastatic disease, or background diseases that limit function.
- Lymphedema prior to surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QuickDASH questionnaire
Time frame: 18 months
a shortened version of the The Disabilities of the Arm, Shoulder and Hand (DASH), that contains 11 items measuring an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to her severity/function level. The the scores range from 0 (no disability) to 100 (most severe disability).
Numeric pain rating scale
Time frame: 18 months
Pain scale reported by patients with rage of 0(no pain)-10(the worst possible pain imaginable).
The Godin-Shephard Leisure-Time Physical Activity
Time frame: 18 months
divides the effort levels into light/ mild, moderate, strenuous and multiply by time per week.
2 secondary outcomes
Number of patients diagnosed with lymphedema
Time frame: 18 months
Shoulder range of motion
Time frame: 18 months
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 17 Nov 2025.
- Derived from this study: PubMed 42157559Klein I, Susmallian S. Long-Term Shoulder Dysfunction After Breast and Axillary Surgery: Impact of Surgical Extent and Predictors of Function. ANZ J Surg. 2026 May 19. doi: 10.1111/ans.70745. Online ahead of print.
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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.
Merav Ben- David, Professor principal investigator
Assuta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ifat Klein at 1 site in Israel.
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 3 inclusion and 3 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 17 Nov 2025. 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 Israel. 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?
QuickDASH questionnaire (time frame: 18 months). The study lists 3 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 NCT05950685, 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 17 Nov 2025.