Breast Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALIndividually Tailored Perioperative Psychological Intervention
A 6-week individually tailored psychological intervention delivered perioperatively, including six sessions with a trained medical psychologist and bi-weekly phone calls. The intervention targets emotional, cognitive, physiological, and behavioral stress responses, and includes psychoeducation, stress-reduction techniques, coping strategies, and enhancement of social support, based on individual patient needs assessed before surgery.
Standard nursing staff attention (treatment-as-usual) without structured psychological intervention.
Sponsors
Rabin Medical Center
SPARK Israel
ICRF, United States
IMH, Israel
IMS, Israel
ISF, Israel
Tel Aviv University, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor gene expression signatures | At surgery (tumor resection) | Transcriptional activity of pro-metastatic, inflammatory, and adrenergic signaling pathways in excised tumors assessed via RNA sequencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress (BSI-18) | Baseline (2-3 weeks before surgery), 3-4 weeks after surgery, and 3 months after surgery | Psychological distress assessed using the Brief Symptom Inventory-18 (BSI-18), including Global Severity Index (GSI) and subscales for depression, anxiety, and somatization. |
| Self-reported stress level | Baseline, 1 day before surgery, 1 day after surgery, 3-4 weeks after surgery, and 3 months after surgery | Self-reported stress level assessed using a 1-100 scale reflecting perceived stress during the previous 24 hours. |
| Hope (Hope-18) | Baseline and 3-4 weeks after surgery | Hope assessed using the Hope-18 questionnaire, including intrapersonal, interpersonal, and transpersonal domains. |
| Perceived social support (MSPSS) | Baseline and 3-4 weeks after surgery | Perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), including family, friends, and significant others subscales. |
| Fatigue (SF-36 subscale) | Baseline and 3-4 weeks after surgery | Fatigue assessed using the fatigue subscale of the Short Form Health Survey (SF-36). |
Countries
Israel
Outcome results
None listed