Addressing survivorship concerns in breast cancer patients
Rehabilitation Needs in Patients With Early Breast Cancer: Validation of a Questionnaire Patient Reported Outcome
This study is trying to create a better questionnaire to help breast cancer survivors share their concerns about fatigue, pain, and emotional struggles so that doctors can understand and support them better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 2 sites (Rome, Roma and 1 other locations) |
| Trial ID | NCT06080607 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on breast cancer survivors who often face various challenges such as fatigue, pain, and psychological distress that significantly impact their quality of life. The study aims to translate and culturally adapt a Patient Reported Outcome (PRO) questionnaire to better identify and address these survivorship concerns. By involving multiple centers, the study seeks to validate the questionnaire's effectiveness in capturing the rehabilitation needs of breast cancer survivors. The ultimate goal is to enhance communication between patients and healthcare providers and improve overall patient satisfaction with care.
Who should consider this trial
Good fit: Ideal candidates for this study are female breast cancer survivors who are experiencing survivorship concerns.
Not a fit: Patients with cognitive or memory impairments may not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved recognition and management of survivorship issues in breast cancer patients, enhancing their quality of life.
How similar studies have performed: Other studies have shown success in using Patient Reported Outcomes to improve patient care and satisfaction, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * During transcultural adaptability 80 representative patients will be recruited . During the validation phase previus patients will be included and more other patients will be included (at least 280) Exclusion Criteria: * Patients with cognitive or memory impairment wil be excluded
Where this trial is running
Rome, Roma and 1 other locations
- Regina Elena Cancer Institute — Rome, Roma, Italy (Active_not_recruiting)
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Patrizia Pugliese
- Email: patrizia.pugliese@ifo.gov.it
- Phone: +39 06 52666155
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.