Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02957981 |
| Other study ID # |
2016-1162 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
April 1, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Georgetown University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
