NCT07510997|CompletedDMC
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Sponsor study identifier
Secondary identifiers
REGISTRY · Israeli Ministry of Health
interventional
40
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)December 31, 2021
Actual (reported)December 31, 2022
Actual (reported)March 29, 2026
Actual (reported)April 6, 2026
Actual (reported)Tumor gene expression signatures
Transcriptional activity of pro-metastatic, inflammatory, and adrenergic signaling pathways in excised tumors assessed via RNA sequencing.
At surgery (tumor resection)
Psychological distress (BSI-18)
Baseline (2-3 weeks before surgery), 3-4 weeks after surgery, and 3 months after surgery
Self-reported stress level
Baseline, 1 day before surgery, 1 day after surgery, 3-4 weeks after surgery, and 3 months after surgery
Hope (Hope-18)
Baseline and 3-4 weeks after surgery
Perceived social support (MSPSS)
Baseline and 3-4 weeks after surgery
Fatigue (SF-36 subscale)
Baseline and 3-4 weeks after surgery
Individually tailored perioperative psychological intervention including six sessions and bi-weekly phone calls targeting emotional, cognitive, physiological, and behavioral stress responses.
Standard nursing staff attention without structured 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.
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492, Israel
Hanalis-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.
40 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2026
First Posted
April 6, 2026
Study Start
January 1, 2018
Actual (reported)Evaluation of the SmartBx System for Breast Biopsy
Exercise in Older Women With Breast Cancer During Systemic Therapy
Standard nursing staff attention (treatment-as-usual) without structured psychological intervention.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
April 6, 2026
Record last verified: 2026-03
IPD will not be publicly shared due to the sensitive nature of clinical, psychological, and genomic data collected in this study, which may pose a risk of participant re-identification. Data may be made available upon reasonable request to the investigators, subject to institutional approvals and applicable data protection regulations.
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Source: ClinicalTrials.gov.
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