Identifying long-term arm issues after breast cancer treatment
Development of a Screening Tool for Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments
Assuta Medical Center · NCT05950685
This study is trying to create a tool to help find women who might have long-term arm problems after breast cancer treatment so they can get the care they need sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1316 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Assuta Medical Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT05950685 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a screening tool to identify women at high risk for prolonged arm morbidity following breast cancer treatments. It involves a systematic review to identify risk factors, followed by a cross-sectional study to develop the tool and a cohort study to validate it. Participants will complete online questionnaires and undergo physical assessments to correlate their arm morbidity with identified risk factors. The ultimate goal is to enhance early detection and proactive treatment for affected patients.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-75 who are independent and speak Hebrew or Russian, and who have undergone breast cancer surgery within the last three years.
Not a fit: Patients with advanced metastatic disease, prior lymphedema, or those who have had additional surgeries affecting arm function will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and quality of life for breast cancer survivors by enabling early intervention for arm morbidity.
How similar studies have performed: Other studies have shown success in identifying risk factors for lymphedema and arm morbidity, making this approach promising but not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tel Aviv
- Assuta medical center — Tel Aviv, Israel (RECRUITING)
Study contacts
- Principal investigator: Merav Ben- David, Professor — Assuta Medical Center
- Study coordinator: Ifat klein, B.PT
- Email: ifatgoldberg@hotmail.com
- Phone: 0506764695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer