The Genetic Education for Men Trial: Web-Based Education vs. Standard Care
Condition: Prostate Carcinoma; Breast Neoplasm; Pancreatic Cancer; BRCA1 Mutation; BRCA2 Mutation
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The primary goal of this research is to develop and test a web-based genetic
      education/counseling intervention. This intervention is designed to educate men from
      hereditary cancer families about the personal relevance of genetic testing in order to help
      them make decisions about whether to pursue genetic testing. The investigators will test this
      intervention against standard care for men from hereditary cancer families. The web-based
      educational intervention includes all of the information typically covered during genetic
      counseling. As a result, after completing the education intervention participants can proceed
      directly to genetic testing if they choose. The investigators will conduct a survey prior to
      randomization and then follow-up surveys at 1-month and 6-months post-randomization. The
      primary outcome will be uptake of genetic testing. Secondary outcomes will be completion of
      genetic counseling and decision satisfaction.
    

Detailed description: 
      Aim 1: Develop a web-based intervention to increase genetic counseling/testing uptake in men
      at high risk for carrying a BRCA mutation.

      Aim 2: Evaluate the impact of the web-based intervention (WI) vs. usual care (UC)

      Aim 3: Examine the behavioral and psychosocial impact of BRCA testing in men from BRCA
      families.

      Identification and Recruitment of Subjects. Participants will be recruited via the Lombardi
      Comprehensive Cancer Center's Familial Cancer Registry and the Non-therapeutic Subject
      Registry Shared Resource. These registries contain over 800 female BRCA1/2 positive
      participants. In addition, the investigators will recontact participants from prior trials
      who have consented to be recontacted for future research and will accept self-referred index
      cases who contact the study about participation. Female index cases will be identified based
      on vital status, recency of contact, and availability of test reports documenting their
      positive BRCA1/2 status. Where available, pedigrees will also be reviewed.

      To protect the privacy of study participants, participants will be recruited through their
      female BRCA mutation carrier relatives (index patients) who will provide their contact
      information. The investigators will identify adult female mutation carriers who are enrolled
      in the Non-therapeutic Subject Registry Shared Resource, Familial Cancer Registry, who
      received a positive test result as a participant in IRB 2004-133 and provided consent to be
      contacted about future research studies or who contact the study directly about enrollment.
      The study staff will mail a study invitation to potentially eligible index cases. This
      mailing will include: an introductory letter; an informed consent document; a HIPAA
      Authorization form; study brochures for distribution to male relatives if desired; and a
      family contact form requesting contact information and current ages for potentially eligible
      male relatives. The investigators will request that index patients return the Family Contact
      Form in a self-addressed stamped envelope or complete an electronic version of the form.
      Consistent with prior research and Institutional Review Board guidance, the letter and Family
      Contact Form will reiterate that index patients should request permission from their
      potentially eligible male relative(s) prior to providing contact information to us, and the
      index patient's signature on the Family Contact Form will attest to this. The packet will
      also contain information on how women may decline participation (an opt-out post card). If,
      after 2-3 weeks, individuals do not decline participation, a research assistant will call to
      determine interest in the study and request completion of the Family Contact Form.

      Upon receiving returned Family Contact Forms, the research team we will contact potentially
      eligible male relatives by mail. The study packet that is sent will include: an introductory
      letter; informed consent document; study brochure, and opt-out postcard. On the opt-out
      contacts, men can also indicate if they are ineligible for the study due to a cancer
      diagnosis or prior genetic counseling/testing.

      Baseline survey. The baseline survey can be completed via telephone or electronically. Two
      weeks following the mailing, the researchers will contact eligible men who have not opted out
      by email or telephone. For email contact, the investigators will send an email link to an
      electronic study consent and baseline survey. If no email address is provided, a research
      assistant will contact the participant by telephone. If the participant has already returned
      the print informed consent document, the research assistant will answer any questions about
      the study and proceed with the baseline survey. If the participant has not returned an
      informed consent document, the research assistant will complete a verbal consent process and
      administer the baseline survey.

      Randomization. Following completion of the baseline survey, a research assistant will
      randomize participants to either the Web Intervention or Usual Care. Randomization will be
      achieved via computer generated random numbers (blocks of 8). Family members will be assigned
      to the same intervention to avoid contamination. Men who complete the baseline survey online
      will be notified of their randomization assignment via email. Men who complete the baseline
      survey by telephone will be notified of their randomization status at the end of the baseline
      survey.

      Usual Care Group. Men who are randomized to the Usual Care arm will receive an email and
      letter informing them of their group assignment. These contacts will include a list of
      resources for men from hereditary cancer families and for those who have not previously
      completed the print or electronic consent form, another copy of the print consent and a link
      to the electronic consent will also be provided. At this time, Usual Care participants will
      be informed that if they are interested in genetic counseling and testing, they can contact
      the study team (via a toll-free number provided to them in the letter) to schedule a
      telephone genetic counseling session (free of charge) or the study team can provide a local
      referral for in-person genetic counseling. All participants will be required to complete the
      print or electronic study consent form prior to study-provided genetic counseling.

      Web Intervention Group. Men randomized to the Web Intervention will receive an email and
      letter (sent through US Mail) with the web address, and an individualized code. When
      participants access the website, they will be asked to enter their email address and their
      code, and then choose a password for future log-ins. Participants who forget their passwords
      can request a new log-in code at any time. The investigators will provide participants with a
      toll-free support number to call if they have any questions. Participants who have not
      completed the print or electronic informed consent document will be required to complete the
      electronic consent prior to viewing the Web Intervention.

      At the conclusion of the Web Intervention, participants will be provided with the following
      options for pursuing genetic testing for their familial BRCA1 or BRCA2 mutation: 1) they can
      indicate that they are not interested in pursuing genetic testing; 2) they can indicate that
      they have questions about genetic testing, in which case an RA will follow-up, answer any
      process-related questions, and determine if a genetic counselor consultation is required; 3)
      they can schedule an individual genetic counseling session (with a LCCC genetic counselor or
      with a genetic counselor of their choice); 4) they can proceed directly to genetic testing.

      Pre-Test Genetic counseling. All participants have multiple options for pre-test genetic
      counseling. Since the Web Intervention provides participants with content that is comparable
      to that of standard pre-test genetic counseling, Web Intervention participants have the
      option to proceed directly to genetic testing after viewing the intervention. However, since
      we expect that some participants may prefer traditional genetic counseling, participants will
      have the option of free pre-test telephone genetic counseling provided through the study by a
      board-certified genetic counselor at the Lombardi Comprehensive Cancer Center. In contrast,
      because Usual Care participants will not receive electronic genetic education/counseling,
      they will not have the option to proceed directly to genetic testing. Usual Care participants
      who are interested in pursuing genetic counseling will have the option to receive free
      pre-test telephone genetic counseling through the study by a board certified genetic
      counselor at Lombardi Comprehensive Cancer Center. After completing genetic counseling,
      participants will be provided with the opportunity to proceed to genetic testing. This arm is
      designed to replicate standard care in which individual genetic counseling often proceeds
      genetic testing.

      Men in either group who prefer in-person genetic counseling, will be provided with a referral
      to a local counselor and informed that those costs are not covered by the study. Men whose
      insurance company requires them to be seen by a genetic counselor within a specified
      organization before testing is ordered will be informed of that requirement if they proceed
      to testing.

      Genetic testing. Genetic testing is not required as part of this study. Any participants
      interested in proceeding with genetic testing will receive standard clinical genetic testing
      from a certified commercial laboratory. All testing will be provided under standard clinical
      protocols and laboratory consents. The standard of care for relatives of BRCA1 or BRCA2
      carriers is to test only for the specific familial mutation. The familial mutation will be
      known to study staff because documentation of test reports must be available for female
      cases, from whom eligible participants for the study are recruited. Men who have Ashkenazi
      Jewish background will be offered testing for the three BRCA mutations common in this ethnic
      group, as is also standard clinical practice. Men will have the option to go through their
      insurance company or pay out of pocket for genetic testing. In either case, the fees
      associated with testing will be paid directly to the clinical laboratory that performs the
      test.

      Coordination of genetic testing. All participants who indicate that they are interested in
      genetic testing will be contacted by a research assistant to obtain information needed for
      insurance billing, pre-verification and the completion of laboratory test requisition forms.
      The research assistant will provide a laboratory consent form and laboratory requisition form
      to participants who are interested in completing genetic testing. After these completed and
      signed forms are returned to us, the research assistant will send the participant a kit to
      collect saliva (DNA). The participant is then responsible for mailing the postage paid DNA
      kit and required forms directly to the testing laboratory. Billing and payment arrangements
      for testing will be handled between the testing lab and the participant. Georgetown
      University will not bill patients for genetic testing services.

      Post-test genetic counseling. All participants who receive genetic testing through the study
      will receive individual post-test genetic counseling by telephone from a board-certified
      genetic counselor. In general, DNA testing results are available within 2 weeks. Results will
      be sent directly to a study genetic counselor. The genetic counselor will call the
      participant to review the test results, including cancer risks, management
      options/guidelines, implications to family members, and emotional response to testing.
      Questions and concerns will be addressed, and referrals for follow-up will be provided as
      needed, including (if appropriate), genetic counseling referrals for relatives. If
      participants did not undergo pre-test genetic counseling, a brief medical and family history
      will be taken at this time, so that risk and management information can be individualized.
      This session is expected to take between 10 to 30 minutes.

      After the post-test session, the genetic counselor will mail a copy of the laboratory's
      genetic testing report and a brief genetic counseling summary letter that the participant can
      share with his health care providers and family members if desired.

      Follow-Up Survey. Participants will be contacted for follow-up surveys at 1-month and
      6-months post-randomization. These surveys will be similar to (but shorter than) the baseline
      survey. As for the baseline survey, these follow-up surveys will be conducted electronically
      or via telephone. Participants who have provided verbal consent at the time of the baseline
      but who have not completed written or electronic consent (and therefore have not proceeded to
      genetic counseling) will remain eligible to complete the follow-up surveys.
    

Intervention name(s): Web-based Counseling; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The web-based genetic counseling and education intervention will include standard information typically provided in individual genetic counseling. the intervention will be individually tailored based upon key clinical and demographic characteristics of the participant.; Standard care includes access to resource list for men from hereditary cancer families plus access to standard clinical genetic counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: BRCA1; BRCA2; Men; Hereditary Cancer; Prostate Cancer; Male Breast Cancer