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Completed

NCT Number: NCT06671704

GC-PRO Intervention

The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.

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Key information

Conditions

Cancer Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Condition Genetic Diseases, Inborn Heart Diseases Neoplasms Prenatal Condition Reproductive Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 years or older
  • individual OR their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site
  • understand and be able to provide information for study forms and surveys in English.

Exclusion criteria

  • Unable to provide informed consent
  • For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.

Treatment and study plan

Genetic counseling months 4-15

Other

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 4 to month 15.

Genetic counseling months 6-15

Other

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 6 to month 15.

Genetic counseling months 8-15

Other

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 8 to month 15.

Genetic counseling at months 10-15

Other

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 10 to month 15.

Genetic counseling at months 12-15

Other

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 12 to month 15.

Genetic counseling at months 14-15

Other

all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 14 to month 15.

Primary outcomes

  1. effectiveness of a genetic counseling skills training intervention

    Time frame: 1 month

    The exact measure of effectiveness has been omitted to ensure no bias is created and that research integrity is preserved

Secondary outcomes

  1. patient perception of overall GC quality

    Time frame: 1 month

    Overall perception of quality of the genetic counseling session

  2. patient-centered communication

    Time frame: 1 month

    An assessment of the patient's experience with their healthcare provider

  3. patient empowerment

    Time frame: 1 month

    A process through which patients gain control over decisions and actions affecting their health

  4. patient activation

    Time frame: 1 month

    A patient's ability to manage their own health and take an active role in their care

  5. patient information needs met / information overload

    Time frame: 1 month

    Assessment of how much information the patient desired and was provided

  6. patients' perceived trust in GC

    Time frame: 1 month

    Measure of patients' trust in their provider

  7. working alliance

    Time frame: 1 month

    Relationship between patient and provider

  8. GC verbal dominance

    Time frame: 1 month

    Measurement of the amount of time the patient, genetic counselor, and other individuals spend talking in the session

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • University of South Florida

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Apr 8, 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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