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Completed

NCT Number: NCT04066361

OPTimizing Treatment Focused Genetic Testing IN Cancer

This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.

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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 Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer 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, 02115, United States

About this study

In this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: Chatbot and video education.

The first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message.

The Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling.

The second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer.

In both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing.

Other studies at both DFCI and outside institutions have started to investigate alternative methods of educating patients about genetic testing. These studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care.

The investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. The investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients over the age of 18
  • With a diagnosis of advanced cancer (defined as Stage 3 or 4), or
  • Any stage for pancreatic cancer and
  • No prior cancer genetic panel testing

Exclusion criteria

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women (if known at the time of participation)
  • Prisoners
  • Non-English speakers

Treatment and study plan

chatbot

Other

Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit

Video education

Other

Brief video designed to mirror the educational components of a traditional genetic counseling visit

Primary outcomes

  1. The measurement of genetic testing uptake

    Time frame: 2 years

    The proportion of participants who consent to genetic testing in each study arm

  2. Meaningful cancer treatment changes

    Time frame: 2 years

    Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.

  3. Satisfaction with pre-genetic test education

    Time frame: at time of post-counseling/video pre-result disclosure, on average 3 weeks

    A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly".

Secondary outcomes

  1. Communication of results with family members

    Time frame: 4 months post-result disclosure

    For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature.

  2. Intent to disclose genetic test results

    Time frame: 1 day (at time of intervention)

    Three items will assess participants' intentions to disclose genetic testing results

  3. Cascade testing of family members

    Time frame: 6 month post-result disclosure

    This will evaluate participant's discussions about genetic testing within the family for an understanding of how genetic testing information was communicated

  4. Decisional regret

    Time frame: 4 months post-result disclosure

    5 items will be asked pertaining to reflecting on the decision of the participant about getting genetic testing after learning about their result.

  5. Knowledge of multi-gene panel testing

    Time frame: 1 day (at the time of intervention)

    A 6 item survey evaluating participant's understanding of inherited genetic risk

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN

Acronym: OPT-IN

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2019
Registry last updated
Jan 25, 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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