Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

The development and the assessment of the screening tool will conduct in three stages:

1. 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.
2. 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.
3. 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.
4. 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 Type: Observational
• Enrollment (Actual): 1602

Contacts and Locations

Study Locations

• Israel
  • Israel
    • Tel Aviv, Israel, Israel, 6345415
      • Assuta Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patient six months till three years after surgery

Description

Inclusion Criteria:

• Patients aged 18-75
• Independent
• Speaking Hebrew and Russian

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	18 months
Numeric pain rating scale	Pain scale reported by patients with rage of 0(no pain)-10(the worst possible pain imaginable).	18 months
The Godin-Shephard Leisure-Time Physical Activity	divides the effort levels into light/ mild, moderate, strenuous and multiply by time per week.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients diagnosed with lymphedema	Diagnosis of lymphedema by a doctor / physical therapist	18 months
Shoulder range of motion	Using DR Goniometer App evaluating ranges of motion in degrees between 0 (no range) to 180 (full range)	18 months

Collaborators and Investigators

• Sponsor: Ifat Klein
• Collaborators: Ben-Gurion University of the Negev
• Investigators: Principal Investigator: Merav Ben- David, Professor, Assuta Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 0019-22ASMC