Perioperative Individually Tailored Psychological Intervention in Breast Cancer Surgery

March 29, 2026 updated by: Rabin Medical Center

Perioperative Individually Tailored Psychological Intervention in Breast Cancer Patients Improves Psychological Indices and Molecular Biomarkers of Metastasis in Excised Tumors

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center - Beilinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychological Intervention
Individually tailored perioperative psychological intervention including six sessions and bi-weekly phone calls targeting emotional, cognitive, physiological, and behavioral stress responses.
Behavioral: Individually 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.
Active Comparator: Standard Care
Standard nursing staff attention without structured psychological intervention.
Other: Standard Nursing Care
Standard nursing staff attention (treatment-as-usual) without structured psychological intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor gene expression signatures
Time Frame: At surgery (tumor resection)
Transcriptional activity of pro-metastatic, inflammatory, and adrenergic signaling pathways in excised tumors assessed via RNA sequencing.
At surgery (tumor resection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress (BSI-18)
Time Frame: 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.
Baseline (2-3 weeks before surgery), 3-4 weeks after surgery, and 3 months after surgery
Self-reported stress level
Time Frame: 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.
Baseline, 1 day before surgery, 1 day after surgery, 3-4 weeks after surgery, and 3 months after surgery
Hope (Hope-18)
Time Frame: Baseline and 3-4 weeks after surgery
Hope assessed using the Hope-18 questionnaire, including intrapersonal, interpersonal, and transpersonal domains.
Baseline and 3-4 weeks after surgery
Perceived social support (MSPSS)
Time Frame: 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.
Baseline and 3-4 weeks after surgery
Fatigue (SF-36 subscale)
Time Frame: Baseline and 3-4 weeks after surgery
Fatigue assessed using the fatigue subscale of the Short Form Health Survey (SF-36).
Baseline and 3-4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

SPARK Israel
ICRF, United States
IMH, Israel
IMS, Israel
ISF, Israel
Tel Aviv University, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-17-0127
  • MOH_2017-08-10_000705 (Registry Identifier: Israeli Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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