24GUT540 : Meeting of Breast Cancer Patients and Pathologists

NCT07040514 | Recruiting DMC

• 1 other identifier: Study02002540
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

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

Questionnaires of Patient understanding of Pathologist input 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)

Assessment of Patient understanding of Pathologist input

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Edward J Gutmann, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse

CONTACT

800-639-6918; cancer.research.nurse@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 27, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

US (1)