Identifying factors affecting upper limb function in breast cancer survivors
Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
KU Leuven · NCT05297591
This study looks at what might be causing ongoing arm problems in women who have been treated for breast cancer to help improve their physical activity and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven (other) |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05297591 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify prognostic variables that contribute to persistent upper limb dysfunctions in women who have undergone treatment for breast cancer. It focuses on assessing upper limb function and the factors that may lead to chronic issues following surgery and radiotherapy. By understanding these variables, the study seeks to highlight barriers to physical activity, which is crucial for improving overall health outcomes in breast cancer survivors.
Who should consider this trial
Good fit: Ideal candidates for this study are women scheduled for surgery for unilateral primary breast cancer or those with oligometastatic breast cancer who can communicate in Dutch.
Not a fit: Patients with widespread distance metastases, previous breast surgery, or those with neurological or rheumatological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for upper limb dysfunction, enhancing the quality of life for breast cancer survivors.
How similar studies have performed: While this study addresses a significant issue in breast cancer survivorship, similar studies have shown varying degrees of success in identifying prognostic factors for upper limb dysfunction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer. * Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant * Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent Exclusion Criteria: * BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery * And/or with a diagnosis of a neurological or rheumatological condition, * And/or BCS who are not available the entire duration of the study
Where this trial is running
Leuven
- Universitair Ziekenhuis Leuven — Leuven, Belgium (RECRUITING)
Study contacts
- Principal investigator: An De Groef, Prof. Dr. — KU Leuven
- Study coordinator: An De Groef, Prof. Dr.
- Email: an.degroef@kuleuven.be
- Phone: 003216376668
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, upper limb dysfunction