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Completed

NCT Number: NCT07510997

Perioperative Individually Tailored Psychological Intervention in Breast Cancer Surgery

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4941492, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Nursing Care

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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