NCT07040514

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

May 12, 2025

Last Update Submit

July 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participant self-rating of understanding of, and empowerment in relation to, their disease, as measured using pre and post-visit knowledge questionnaires, and survey after meeting with a pathologist.

    Determine understanding improvement from pre-meeting questionnaires and after pathologist visit with post-visit questionnaires, as well as knowledge questionnaire for both timepoints. Knowledge Questionnaire: Primary Score: Total Score - Total # correct responses on the knowledge questions (12 items total). Survey for Patients after Meeting with Pathologist Primary Score: Item 1 Total Score - Responses will be coded on a 0-4 scale where 0=strongly disagree and 4=strongly agree, and the total will be calculated across items 'a' through 'j' of Item 1.

    1-2 weeks

Secondary Outcomes (2)

  • Participant knowledge of their personal disease characteristics

    1-2 weeks

  • Participant general knowledge of breast cancer pathology

    1-2 weeks

Other Outcomes (3)

  • Participant ratings of helpfulness and other features of meeting with a pathologist such as comfort level with the meeting

    1-2 weeks

  • Participant anxiety self-rating

    1-2 weeks

  • Pathologist rating of patient benefit from the meeting and other features of the meeting such as degree to which rapport was established.

    1-2 weeks

Study Arms (1)

Assessment of Patient understanding of Pathologist input

OTHER

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.

Other: Questionnaires of Patient understanding of Pathologist input

Interventions

* 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)

Assessment of Patient understanding of Pathologist input

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Edward J Gutmann, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: To determine whether meeting with a pathologist to review and discuss the pathologic findings in their breast samples is beneficial to breast cancer patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2025

First Posted

June 27, 2025

Study Start

July 10, 2025

Primary Completion

April 2, 2026

Study Completion

April 2, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations