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NCT Number: NCT05470920

Genetic Testing Decision Aid

This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer

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Key information

Conditions

Epithelial Ovarian Carcinoma Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Pancreas Adenocarcinoma Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include:

  • Knowledge Survey
  • Shared Decision Making Process Survey
  • Decisional Conflict Scale

The research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study.

The National Cancer Institute (NCI) is supporting this research study by providing funding for the research

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Being seen in clinic at Massachusetts General Hospital or Boston Medical Center
  • Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.

Exclusion criteria

  • Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study
  • Previous germline genetic testing
  • History of hereditary pancreatitis
  • Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults

Treatment and study plan

Electronic Decision Aid

Behavioral

Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires

Pre-Test Genetic Counseling

Behavioral

Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires

Primary outcomes

  1. Average change in knowledge survey score

    Time frame: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks

    Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.

  2. Decisional Conflict Scores

    Time frame: 1 week after genetics session

    The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.

  3. Shared Decision Making Process Scores

    Time frame: 1 week after genetics session

    The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.

Secondary outcomes

  1. Average time between genetic testing recommendation and sample collection

    Time frame: Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months

    Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.

  2. Average Duration of Decision Making Process

    Time frame: Approximately 30 minutes - 1 hour

    Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.

  3. Ratio of the number of participants who chose each of the three panels offered

    Time frame: At the conclusion of genetics session (day 1)

    Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.

  4. Percentage of participants choosing genetic testing

    Time frame: At the conclusion of genetics session (day 1)

    Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention

Study contacts

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

Daniel C. Chung, MD

CONTACT

[email protected]

(617) 726-8687

Danielle A Lynch, BS

CONTACT

[email protected]

(617) 726-1355

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2022
Registry last updated
Aug 13, 2025

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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