Breast CancerNCT07510997
Perioperative Individually Tailored Psychological Intervention in Breast Cancer Surgery
A study testing Individually Tailored Perioperative Psychological Intervention and Standard Nursing Care in people with Breast Cancer, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Individually Tailored Perioperative Psychological Intervention and Standard Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with stage I-III breast cancer
- Scheduled for curative surgery
- Age 20-80
Who cannot join
- Metastatic disease
- Neoadjuvant therapy
- Other malignancy
- Severe psychiatric conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Individually Tailored Perioperative Psychological Intervention, Standard Nursing Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually Tailored Perioperative Psychological InterventionBehavioural
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 CareOther
Standard nursing staff attention (treatment-as-usual) without structured psychological intervention.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | Individually tailored perioperative psychological intervention including six sessions and bi-weekly phone calls targeting emotional, cognitive, physiological, and behavioral stress responses. Receives: Behavioral: Individually Tailored Perioperative Psychological Intervention |
| Standard Care | Active comparator | Standard nursing staff attention without structured psychological intervention. Receives: Other: Standard Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor gene expression signatures
Transcriptional activity of pro-metastatic, inflammatory, and adrenergic signaling pathways in excised tumors assessed via RNA sequencing.
Measured: At surgery (tumor resection)
Secondary outcomes (5)
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.
Measured: Baseline (2-3 weeks before surgery), 3-4 weeks after surgery, and 3 months after surgery
Self-reported stress level
Self-reported stress level assessed using a 1-100 scale reflecting perceived stress during the previous 24 hours.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 3-4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- SPARK Israel, ICRF, United States, IMH, Israel, IMS, Israel, ISF, Israel, Tel Aviv University, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510997
- Sponsor's protocol ID
- RMC-17-0127
- Other IDs
- MOH_2017-08-10_000705
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38346596
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Individually Tailored Psychological Intervention in Breast Cancer Patients Improves Psychological Indices and Molecular Biomarkers of Metastasis in Excised Tumors
- ClinicalTrials.gov ID
- NCT07510997
- Acronym / sponsor ID
- RMC-17-0127
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- SPARK Israel, ICRF, United States, IMH, Israel, IMS, Israel, ISF, Israel, Tel Aviv University, Israel
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Individually Tailored Perioperative Psychological InterventionIndividually tailored perioperative psychological intervention including six sessions and bi-weekly phone calls targeting emotional, cognitive, physiological, and behavioral stress responses. |
| Standard Care | Active comparator | Other: Standard Nursing CareStandard nursing staff attention without structured psychological intervention. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with stage I-III breast cancer
- Scheduled for curative surgery
- Age 20-80
Key exclusion criteria (4 listed)
- Metastatic disease
- Neoadjuvant therapy
- Other malignancy
- Severe psychiatric conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individually Tailored Perioperative Psychological InterventionA 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. | Behavioural | Psychological Intervention |
| Standard Nursing CareStandard nursing staff attention (treatment-as-usual) without structured psychological intervention. | Other | Standard Care |
Primary outcome
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.
5 secondary outcomes
Psychological distress (BSI-18)
Time frame: 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
Hope (Hope-18)
Time frame: Baseline and 3-4 weeks after surgery
Perceived social support (MSPSS)
Time frame: Baseline and 3-4 weeks after surgery
Fatigue (SF-36 subscale)
Time frame: Baseline and 3-4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Results publication: PubMed 38346596Hanalis-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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually Tailored Perioperative Psychological Intervention and Standard Nursing Care in people with Breast Cancer, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor gene expression signatures (time frame: At surgery (tumor resection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07510997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.