Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02957981
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2016-11-04
Brief Title:
The Genetic Education for Men Trial Web-Based Education vs Standard Care
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
The Genetic Education for Men GEM Trial Web-Based Genetic Education vs Standard Care in Men From Hereditary Cancer Families
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM
Brief Summary:
The primary goal of this research is to develop and test a web-based genetic educationcounseling 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 counselingtesting 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 Centers Familial Cancer Registry and the Non-therapeutic Subject Registry Shared Resource These registries contain over 800 female BRCA12 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 BRCA12 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 relatives prior to providing contact information to us and the index patients 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 counselingtesting
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 educationcounseling 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 optionsguidelines 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 laboratorys 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
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 Centers Familial Cancer Registry and the Non-therapeutic Subject Registry Shared Resource These registries contain over 800 female BRCA12 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 BRCA12 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 relatives prior to providing contact information to us and the index patients 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 counselingtesting
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 educationcounseling 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 optionsguidelines 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 laboratorys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None