Clinical trial · Interventional
Perioperative Individually Tailored Psychological Intervention in Breast Cancer Surgery
Perioperative Individually Tailored Psychological Intervention in Breast Cancer Patients Improves Psychological Indices and Molecular Biomarkers of Metastasis in Excised Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled trial examined whether a perioperative individually tailored psychological intervention can reduce psychological distress and modulate pro-metastatic molecular processes in breast cancer patients undergoing surgery. Forty women with stage I-III breast cancer were randomized to receive either a 6-week individualized psychological intervention or standard nursing care. Primary outcomes included tumor gene expression profiles associated with adrenergic, inflammatory, and metastatic signaling pathways. Secondary outcomes included psychological distress, stress, and resilience measures assessed across multiple perioperative time points.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individually Tailored Perioperative Psychological Intervention | Behavioral | — | UNRESOLVED |
| Standard Nursing Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psychological Intervention
- description
- Individually tailored perioperative psychological intervention including six sessions and bi-weekly phone calls targeting emotional, cognitive, physiological, and behavioral stress responses.
- interventionNames
- Behavioral: Individually Tailored Perioperative Psychological Intervention
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- Standard nursing staff attention without structured psychological intervention.
- interventionNames
- Other: Standard Nursing Care
Primary outcomes (1)
- measure
- Tumor gene expression signatures
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women with stage I-III breast cancer * Scheduled for curative surgery * Age 20-80 Exclusion Criteria: * Metastatic disease * Neoadjuvant therapy * Other malignancy * Severe psychiatric conditions
References
Publications (1)
- RESULTHanalis-Miller T, Ricon-Becker I, Sakis N, Trachtenberg E, Ohayon F, Wadhawker S, Birnboim Y, Magen A, Sharon E, Tarrasch R, Goldzweig G, Cole SW, Jacoby R, Ben-Eliyahu S. Peri-operative individually tailored psychological intervention in breast cancer patients improves psychological indices and molecular biomarkers of metastasis in excised tumors. Brain Behav Immun. 2024 Mar;117:529-540. doi: 10.1016/j.bbi.2024.02.009. Epub 2024 Feb 10. PMID 38346596