Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- QuickDASH questionnaire
- timeFrame
- 18 months
- description
- 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).
- measure
- Numeric pain rating scale
- timeFrame
- 18 months
- description
- Pain scale reported by patients with rage of 0(no pain)-10(the worst possible pain imaginable).
- measure
- The Godin-Shephard Leisure-Time Physical Activity
- timeFrame
- 18 months
- description
- divides the effort levels into light/ mild, moderate, strenuous and multiply by time per week.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKlein 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. PMID 42157559