Evaluating the effects of expressive writing on body image after breast cancer surgery
Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer
This study is testing if expressive writing can help improve body image and mental health for people recovering from breast cancer surgery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT05616988 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of a psychological intervention using expressive writing on the mental and physical health of patients undergoing mastectomy and breast reconstruction due to breast cancer. Participants will be randomly assigned to two groups: one receiving the expressive writing intervention and the other receiving standard care. The study will measure changes in psychological well-being, inflammatory markers, and the tryptophan/kynurenine ratio. The goal is to understand how emotional support can enhance recovery and body image perception post-surgery.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with breast cancer who are scheduled for surgical mastectomy and reconstruction.
Not a fit: Patients with metastatic disease, those refusing reconstruction, or those with existing psychopathological diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the psychological well-being and body image of breast cancer patients after surgery.
How similar studies have performed: While the approach of using expressive writing in cancer care is promising, this specific application in breast cancer reconstruction is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of diagnosis of breast cancer * indication to undergo surgical mastectomy treatment * Italian nationality * level of education not lower than a secondary school diploma, ensuring sufficient writing skills. Exclusion Criteria: * the occurrence of metastases and/or relapse during the study phase, * the refusal of patients to undergo reconstruction treatment * the presence of existing psychopathological diagnosis
Where this trial is running
Rome, Rome
- Sant'Andrea Hospital, Faculty of Medicine and Psychology "La Sapienza'' University of Rome — Rome, Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Lai — Department of Dynamic and Clinical Psychology, and Health Studies Sapienza University of Rome
- Study coordinator: Carlo Lai
- Email: carlo.lai@uniroma1.it
- Phone: 0649917599
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.