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NCT Number: NCT05225428

Video Education With Result Dependent dIsclosure

The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.

Recruiting

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Key information

Conditions

Genetic Testing Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Renal Cancer Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Huma Q Rana, MD

CONTACT

[email protected]

617-632-6292

Huma Q Rana, MD

PRINCIPAL_INVESTIGATOR

About this study

This study consists of two parts:

  • Qualitative assessment:
  • This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants.
  • The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial.
  • Randomized control trial:
  • A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
  • Ability to understand spoken or written English or Spanish in a healthcare context
  • Ability to understand and the willingness to sign a written informed consent document
  • Black or Latinx (qualitative assessment study only)

Exclusion criteria

  • Prior cancer genetic testing
  • Prior germline genetic testing
  • Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
  • Currently pregnant
  • Currently incarcerated

Treatment and study plan

Video Education

Behavioral

Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit

Other names: VERDI

Genetic Counseling

Behavioral

Standard genetic counseling

Primary outcomes

  1. Video Education Acceptability (Qualitative Interview Study)

    Time frame: 3 Weeks

    Pre- and post-test of knowledge of hereditary cancer risk and cancer genetic counseling with qualitative patient interview question domains and instruments to assess understanding of language and imagery of video education as correlated with measures of health literacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Huma Q. Rana, MD. MPH

CONTACT

[email protected]

617) 632-6292

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Human Genome Research Institute (NHGRI)

Registry information

Acronym: VERDI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2022
Registry last updated
May 22, 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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