Telerehabilitation for managing complications after breast cancer surgery
Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial
This study is testing if telerehabilitation can help women who have had breast cancer surgery avoid complications like pain and movement issues better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Locations | 1 site (Roma, Roma) |
| Trial ID | NCT06608446 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a telerehabilitation intervention aimed at preventing complications following breast cancer surgery, specifically focusing on postoperative pain, musculoskeletal issues, and functional limitations. Patients who have undergone mastectomy or quadrantectomy will be divided into two groups: one receiving telerehabilitation and the other receiving standard care. The primary objective is to assess whether telerehabilitation reduces the onset of complications compared to standard procedures, while secondary objectives include evaluating prognostic factors and improvements in pain, range of motion, muscle strength, and quality of life.
Who should consider this trial
Good fit: Ideal candidates include women over 18 years old who have been diagnosed with breast cancer and have undergone quadrantectomy or mastectomy.
Not a fit: Patients with neurological deficits affecting the upper limb or cognitive impairments that hinder questionnaire completion may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce postoperative complications and improve recovery outcomes for breast cancer surgery patients.
How similar studies have performed: Previous studies have indicated that early postoperative exercise can improve shoulder function, suggesting potential success for this telerehabilitation approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of breast cancer * Having undergone quadrantectomy or mastectomy surgery * Age \> 18 years * Signature of informed consent Exclusion Criteria: * Neurological deficits with sensorimotor impairment of the upper limb * Cognitive deficits that prevent the completion of questionnaires (MMSE\>24)
Where this trial is running
Roma, Roma
- Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Silvia Sterzi, MD
- Email: s.sterzi@policlinicocampus.it
- Phone: +390622541624
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.