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Completed

NCT Number: NCT04330716

Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers

This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Metastatic Prostate Cancer Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital 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, United States

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About this study

This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease.

  • The research study procedures include screening for eligibility, randomization and a series of questionnaires.
  • Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed

Two methods of pre-genetic test education:

  • video education
  • in-person counseling
  • Genetic testing will be performed by blood draw.
  • It is expected that 500 people will participate in this study
  • Participants will be in the research study for up to 5 yrs after enrollment

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility.
  • A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment
  • Age ≥ 18 years
  • Breast, ovarian, pancreatic, or metastatic prostate cancer
  • No prior cancer genetic testing
  • Ability to understand and the willingness to sign an informed consent document

Exclusion criteria

  • Pregnant
  • Prisoners
  • Inability to understand English as a spoken language in a healthcare context
  • Known hematologic malignancy (e.g. CLL)

Treatment and study plan

Standard Genetic Counseling

Behavioral

Standard of care genetic counseling

Educational Video

Behavioral

Video tutorial about genetic testing

Primary outcomes

  1. Rate of patients who have germline genetic tests

    Time frame: Up to 3 years

    Measurement of genetic testing uptake in breast, ovarian, pancreatic, and prostate cancer patients randomized to pre-genetic test (pre-test) in-person counseling with a genetic counselor per standard of care or video education.This comparison will use a two-sided Fisher exact test

Secondary outcomes

  1. Patient Satisfaction Survey following intervention

    Time frame: Immediately following intervention

    Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered immediately following the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms.

  2. Result Disclosure Preference following intervention

    Time frame: Immediately following intervention

    Measurement and comparison by randomized arm and communication of results of patient disclosure preferences using survey instruments. Administered immediately following the intervention.

  3. Patient Satisfaction 2 months following intervention

    Time frame: after results have been received, two months post-intervention

    Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered two months after the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms.

  4. Psychological distress following intervention

    Time frame: after results have been received, two months post-intervention

    MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this.

  5. Knowledge about genetics testing

    Time frame: Immediately following intervention

    Measurement and comparison by randomized arm and communication of results of Patient knowledge about genetics testing using survey instruments. Knowledge about genetic testing is evaluated through a Knowledge of Multigene Panel Testing survey immediately following the intervention.

  6. Decisional Regret

    Time frame: after results have been received, two months post-intervention

    Measurement and comparison by randomized arm and communication of results of Patient decisional regret to have genetic testing. Decisional regret is evaluated through a decisional regret survey that is administered two months after intervention.

  7. Family communication of genetic test results

    Time frame: after results have been received, two months post-intervention

    Measurement of family communication. Family communication survey is administered two months following the intervention.

  8. Positive Results impact

    Time frame: after results have been received, four months post-intervention

    Measurement of impact of positive results for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.

  9. Cascade testing in positives

    Time frame: after results have been received, four months post-intervention

    Measurement of cascade testing for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Ambry Genetics

Registry information

Official study title

Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP

Acronym: GeneBOPP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2020
Registry last updated
Jan 19, 2024

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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