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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
40
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.
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel
Tumor gene expression signatures
Transcriptional activity of pro-metastatic, inflammatory, and adrenergic signaling pathways in excised tumors assessed via RNA sequencing.
Time frame: At surgery (tumor resection)
Psychological distress (BSI-18)
Psychological distress assessed using the Brief Symptom Inventory-18 (BSI-18), including Global Severity Index (GSI) and subscales for depression, anxiety, and somatization.
Time frame: Baseline (2-3 weeks before surgery), 3-4 weeks after surgery, and 3 months after surgery
Self-reported stress level
Self-reported stress level assessed using a 1-100 scale reflecting perceived stress during the previous 24 hours.
Time frame: Baseline, 1 day before surgery, 1 day after surgery, 3-4 weeks after surgery, and 3 months after surgery
Hope (Hope-18)
Hope assessed using the Hope-18 questionnaire, including intrapersonal, interpersonal, and transpersonal domains.
Time frame: Baseline and 3-4 weeks after surgery
Perceived social support (MSPSS)
Perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), including family, friends, and significant others subscales.
Time frame: Baseline and 3-4 weeks after surgery
Fatigue (SF-36 subscale)
Fatigue assessed using the fatigue subscale of the Short Form Health Survey (SF-36).
Time frame: Baseline and 3-4 weeks after surgery
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