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Perioperative Individually Tailored Psychological Intervention in Breast Cancer Surgery

NCT07510997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

Interventions

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.

OTHER

Standard Nursing Care

Standard nursing staff attention (treatment-as-usual) without structured psychological intervention.

Sponsors & Collaborators

  • SPARK Israel

    collaborator UNKNOWN

  • ICRF, United States

    collaborator UNKNOWN

  • IMH, Israel

    collaborator UNKNOWN

  • IMS, Israel

    collaborator UNKNOWN

  • ISF, Israel

    collaborator UNKNOWN

  • Tel Aviv University, Israel

    collaborator UNKNOWN

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510997 on ClinicalTrials.gov