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| ID | Type | Description | Link |
|---|---|---|---|
| MOH_2017-08-10_000705 | Registry Identifier | Israeli Ministry of Health |
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| Name | Class |
|---|---|
| SPARK Israel | UNKNOWN |
| ICRF, United States | UNKNOWN |
| IMH, Israel | UNKNOWN |
| IMS, Israel |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological Intervention | Experimental | Individually tailored perioperative psychological intervention including six sessions and bi-weekly phone calls targeting emotional, cognitive, physiological, and behavioral stress responses. |
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| Standard Care | Active Comparator | Standard nursing staff attention without structured psychological intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individually Tailored Perioperative Psychological Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (2-3 weeks before surgery), 3-4 weeks after surgery, and 3 months after surgery |
| Self-reported stress level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center - Beilinson Hospital | Petah Tikva | 4941492 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38346596 | Result | 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. |
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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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ISF, Israel | UNKNOWN |
| Tel Aviv University, Israel | UNKNOWN |
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| Standard Nursing Care | Other | Standard nursing staff attention (treatment-as-usual) without structured psychological intervention. |
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Self-reported stress level assessed using a 1-100 scale reflecting perceived stress during the previous 24 hours. |
| 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. | 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. | 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). | Baseline and 3-4 weeks after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |