24GUT540 : Meeting of Breast Cancer Patients and Pathologists

NCT ID: NCT07040514

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-10

Study Completion Date

2028-06-01

Brief Summary

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Historically, most pathologists have had little direct contact or communication with patients. In the past two decades, however, there has been a modest movement toward patient-pathologist visits in which pathologists review with patients their pathology slides.

Very few studies of such encounters have been conducted. Most surveyed patients reported that the experience was positive and helpful to them. Our basic goal is to determine if such meetings are useful to patients; a secondary goal is to determine if such encounters are useful to, and practical for, pathologists.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To determine whether meeting with a pathologist to review and discuss the pathologic findings in their breast samples is beneficial to breast cancer patients.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Assessment of Patient understanding of Pathologist input

Assessment of patient understanding of, and sense of control regarding, their disease, and their perception of the potential benefit of having pathologists on their medical team.

Group Type OTHER

Questionnaires of Patient understanding of Pathologist input

Intervention Type OTHER

* Benefit Self-Rating Total Score (assessing patient's perceptions of anticipated and actual extent to which they benefitted from the meeting with the pathologist)
* Knowledge Questionnaire Total Score (assessing accuracy of knowledge of their own diagnosis and the diagnostic process in general)
* State-Trait Anxiety Inventory Form Y (Total Scores for state (current) and trait (general) anxiety)

Interventions

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Questionnaires of Patient understanding of Pathologist input

* Benefit Self-Rating Total Score (assessing patient's perceptions of anticipated and actual extent to which they benefitted from the meeting with the pathologist)
* Knowledge Questionnaire Total Score (assessing accuracy of knowledge of their own diagnosis and the diagnostic process in general)
* State-Trait Anxiety Inventory Form Y (Total Scores for state (current) and trait (general) anxiety)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Must be at least 18 years of age.
2. Patients must have completed initial diagnosis visit with oncologist or surgeon.
3. Must have pathology slides and reports available for review.
4. Must be able to speak English.
5. Must be willing to participate in this research and will be provided with an information sheet.
6. Pregnant women are eligible as this research poses no risk of physical harm to the participant.

Exclusion Criteria

1. Patients \<18 years of age.
2. Patients with DCIS are ineligible.
3. Adults who are unable to provide written signature.
4. Patients from vulnerable patient populations, including infants, minors, those unable to provide informed consent, and those incarcerated or imprisoned at the time of enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Edward.J.Gutmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward J Gutmann, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Research Nurse

Role: CONTACT

800-639-6918

Other Identifiers

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Study02002540

Identifier Type: -

Identifier Source: org_study_id

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