Evaluating psychological well-being in breast cancer patients
Resources Assessment to Increase pSychological dEvelopment in Breast Cancer Patients
This study looks at the mental health of women with early-stage breast cancer to see how they cope and feel before, during, and after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06590727 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the psychological well-being of patients diagnosed with non-metastatic breast cancer. It aims to assess psychological distress and individual coping resources through a structured evaluation process that includes psychological counseling and psychodiagnostic assessments. Patients will be evaluated at three key time points: before hospitalization, during the perioperative phase, and nine months post-surgery. The goal is to enhance treatment adherence and promote post-traumatic growth.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for surgery and may require adjuvant or neoadjuvant treatment.
Not a fit: Patients under 18 years old or those with severe language deficits or barriers to understanding informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve psychological support and treatment outcomes for breast cancer patients.
How similar studies have performed: Other studies have shown that psychological assessments can significantly impact treatment adherence and patient outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years * candidates for surgery * candidates for adjuvant and/or neoadjuvant treatment Exclusion Criteria: * 0 to 17 years old * severe language deficits * severe barriers * Patients unable to understand and express informed consent
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOS Psicologia Clinica — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Daniela Belella — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Daniela Belella
- Email: daniela.belella@policlinicogemelli.it
- Phone: +390630156280
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.