Evaluating psychological well-being in breast cancer patients
Official title: Resources Assessment to Increase pSychological dEvelopment in Breast Cancer Patients
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06590727 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 2400 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | March 31, 2024 |
| Main results expected | March 31, 2028 |
| Study ends | July 31, 2029 |
| Registry record updated | August 14, 2025 |
| Trial ID | NCT06590727 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are scheduled for surgery and may require adjuvant or neoadjuvant treatment.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this study could improve psychological support and treatment outcomes for breast cancer patients.
How similar studies have gone: Other studies have shown that psychological assessments can significantly impact treatment adherence and patient outcomes, indicating a promising approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.