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

NCT05950685 | Completed

• 1 other identifier: 0019-22ASMC
• Study Type: observational
• Target: 1,602
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of patients diagnosed with lymphedema

  18 months

• Shoulder range of motion

  18 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patient six months till three years after surgery

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ifat Klein: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Assuta medical center

Tel Aviv, Israel, 6345415, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Merav Ben- David, Professor

  Assuta Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical therapy coordinator of the field of breast cancer patients treatments

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: July 18, 2023
• Study Start: January 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2024-07

Locations

IL (1)