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Completed

NCT Number: NCT07040514

24GUT540 : Meeting of Breast Cancer Patients and Pathologists

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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)

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.

    Time frame: 1-2 weeks

    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.

Secondary outcomes

  1. Participant knowledge of their personal disease characteristics

    Time frame: 1-2 weeks

    Determined by participant completing pre-and-post visit Knowledge Questionnaires.

    Knowledge Questionnaire: Primary Score: Total Score - Total # correct responses on the knowledge questions (12 items total).

  2. Participant general knowledge of breast cancer pathology

    Time frame: 1-2 weeks

    Determined by participant completing pre-and-post visit Knowledge Questionnaires.

    Knowledge Questionnaire: Primary Score: Total Score - Total # correct responses on the knowledge questions (12 items total).

Other outcomes

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

    Time frame: 1-2 weeks

    Determined by participant completing post-visit survey.

    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.

  2. Participant anxiety self-rating

    Time frame: 1-2 weeks

    Determined by participant completing State Trait Anxiety Inventory (STAI).

    STAI Form Y-1 contains 40 items, each given a self-reported rating of 1-4, with 1: "Not at all", 2: "Somewhat, 3: "Moderately so", and 4: "Very much so".

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

    Time frame: 1-2 weeks

    Determined by pathologist completing the post-visit survey.

    Survey for Pathologist After Meeting with Patient Primary Score: Total Score on Items 6 and 7 (8 items total) - Responses will be coded on a 0-4 scale where 0=highly dissatisfied and 4=highly satisfied, and the total will be calculated for items 6 and 7.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

24GUT540: Opportunity for Breast Cancer Patients to Meet With a Pathologist to Review the Pathology Slides of Their Breast Samples

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jul 30, 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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