Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03544983
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-13
First Post:
2018-05-22
Brief Title:
Genetic Education in BRCA Families
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Randomized Trial of Proactive Outreach and Streamlined Genetic Education in BRCA Families
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
None
Brief Summary:
The primary goal of this research is to test a web-based genetic education intervention that is designed to educate men and women from hereditary cancer families about the personal relevance of genetic testing in order to help them male decisions about whether to pursue genetic testing We will test this intervention against standard care for men and women 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 a brief telephone call with a genetic counselor followed by testing if they choose A baseline survey will be administered prior to randomization and then follow-up surveys will be administered at 1-month and 6-months post-randomization Primary outcomes will be completion of genetic counseling uptake of genetic testing genetic test results and quality of life
Detailed Description:
Women who carry a pathogenic BRCA variant PV have a lifetime breast cancer risk of 55-70 and a lifetime ovarian cancer risk of 16-45 Men with a PV are at increased risk for prostate pancreatic and breast cancer BRCA testing typically begins with a family member proband who is affected with cancer If a PV is identified probands are encouraged to communicate this test result with at risk relatives Unaffected first- and second-degree relatives FSDR who are at 50 and 25 risk for carrying the PV may then pursue genetic counseling and testing for the specific variant identified in the proband targeted testing Targeted testing is far less complex and expensive than testing probands and definitively distinguishes carriers from non-carriers Such testing allows carriers to reduce their cancer incidence morbidity and mortality through risk reduction and screening while non-carriers can avoid unnecessary medical intervention and their offspring can safely forgo testing Despite these well-recognized significant benefits and clear guideline-based recommendations for genetic counseling and testing only 28-57 of FSDRs undergo BRCA testing This low rate of participation occurs despite high rates of result communication by probands calling into question the quality of the information communicated and the accuracy of FSDRs understanding of the importance of the information Additional barriers to counseling and testing include limited access lack of referral time and travel commitment and lack of proactive clinical approaches to facilitate uptake
Remarkably there have been no randomized trials focused on increasing use of guideline consistent genetic counseling and targeted testing Guided by the Informed Choice ICM and Health Belief Models HBM the investigators will conduct a randomized controlled trial of proactive Web-based pre-test education plus a streamlined telephone genetic information session WT vs usual care UC for unaffected FSDRs of PV carriers Web-based pre-counseling education followed by a streamlined telephone genetic information session will be proactively delivered Following counseling participants will have the option to proceed directly to targeted testing By proactively providing access to accurate genetic information and reducing barriers to genetic services WT is predicted to yield increased uptake of genetic counseling and testing
Aim 1 Evaluate the impact of web-based intervention plus brief telephone information WT vs Usual Care UC on uptake of genetic counseling and targeted genetic testing
Aim 2 Evaluate the impact of WT vs UC on psychosocial outcomes
Aim 3 Evaluate mechanisms and moderators of WT
Research Overview The aim of this RCT is to evaluate the efficacy of proactively delivered Web Pre-Test Education plus Streamlined Telephone Counseling WT for first- and second-degree relatives FSDRs of individuals who have recently received a positive BRCA test result ie probands The WT intervention is designed to facilitate access to genetic education and counseling foster informed decisions and reduce barriers to targeted genetic testing The primary hypotheses are that WT participants will have increased uptake of genetic counseling and targeted genetic testing relative to UC participants Eligible FSDRs will be contacted for a baseline assessment One-month following the baseline assessment all participating FSDRs will be randomized by family to either WT or UC FSDRs will be reassessed at 1- and 6-months post-randomization and probands will be reassessed at 6-months post-randomization to enumerate additional testing in the family
Identification and Enrollment Probands will be recruited within the clinical genetics programs at LCCC George Washington University GWU Geisinger Clinic and Dana Farber Cancer Institute DFCI through direct referrals from local cancer genetics programs MedStar Franklin Square Medical Center Sibley Hospital and Inova Schar Cancer Institute We will enroll probands who have received a positive BRCA test result within the prior 12-months At GLCCC and GWU we routinely obtain permission to recontact BRCA probands at the time of their test result disclosure At Geisinger Clinic and DFCI study staff will obtain and document participant permission to share contact information with the study team For participants referred by outside clinical providers Franklin Square Sibley and Inova the provider will obtain patient permission to share contact information with the study team We will also enroll self-referred probands who will be identified in two ways First we will advertise the study on social media FacebookInstagramGoogle FacebookInstagramGoogle users who click on the study advertisement will be taken to our study website where they can review basic study information or find contact information to reach the study team with any questions Those who wish to proceed can then go directly to our secure REDCap page where they can complete a brief eligibility screener Second we will recruit self-referred probands who receive positive test results from the Ambry Genetics genetic testing laboratory Patients who have received a positive BRCA1BRCA2 test result within the past 12-months through Ambry will be identified by Ambry Genetics Ambry Genetics will then provide study information to the ordering providers who will be asked to pass this information along wit a study invitation to their potentially eligible patients Patients who respond to the study invitation will then be taken to the REDCap screening page described above Eligible probands will be contacted for enrollment a minimum of one-month following disclosure and a maximum of 12-months At that time they will be asked for consent to access their genetic counselingtesting records and provide the names addresses and telephone numbers of all potentially eligible FSDRs Participating probands will be asked to inform all potentially eligible FSDRs about the planned study contact
After obtaining contact information potentially eligible FSDRs will be mailed a recruitment packet introductory letter study brochure informed consent document opt-out e-mailaddresstelephone number Two weeks later a research assistant will call all FSDRs who have not opted out of the study The RA will explain the study and answer any questions At enrollment participants will be informed that written consent is required prior to randomization They will also be informed of the randomization date and that they must complete their baseline survey before that date in order to participate in the study
Baseline Assessment Individuals who remain eligible and interested can complete the 20 minute baseline survey via telephone by a trained RA or electronically For those who do not return the consent document prior to the baseline an RA will use an IRB-approved verbal consent for telephone baselines or electronic consent for electronic baselines Written consent will be required prior to randomization
Randomization Following the baseline participants will be provided with a randomization date on which they will be contacted with their assignment Participants will be randomized by family to avoid contamination Randomization will take place 1 month after enrollment of the first FSDR in a family At that point FSDRs who have not completed a baseline will be ineligible for the study Participants will be informed of the randomization deadline upon enrollment On the randomization date participants will be notified by email or phone followed by a priority letter For WT participants this letter will contain log-in information website instructions For UC participants this letter will include a list of informational resources including a list of low-cost genetic counseling options
Interventions
Usual Care As part of standard clinical genetic counseling probands with a BRCA mutation are provided with an individualized summary letter that includes cancer risks management recommendations and options a family letter that identifies at-risk relatives and encourages them to share the test result with these relatives All participants in both arms will receive these standard materials As described above following randomization UC participants will be notified of their assignment and will receive a list of informational resources Of course they can pursue standard clinical genetic counseling on their own at any of our study sites or any other program
The WT Intervention The WT intervention includes Interactive Pre-Test Web-Education plus a streamlined telephone information session directly scheduled through the web site and for those who opt for testing a telephone genetic counseling disclosure session The WT pre-test Web component is designed to provide comparable information to a traditional genetic counseling session for an FSDR of a mutation carrier A detailed description of the content of the WT is described in the treatment plan below Participants will receive an individualized link to the website that is connected to their email address They will be able to create their own password the first time they access the website and then log back into the website in the future using their email address and created password The website has a forgot password option where participants can create a new password at any time The study will provide participants with a toll-free support number to call if they have any questions After reviewing the website participants will be provided with the option to schedule a brief telephone information session with a trained genetic research assistant This session will take approximately 15 minutes and is designed to supplement and reinforce the web-based information This session will be provided free of charge Participants can decline
Genetic Testing Genetic testing is not required as part of this study Any participants who proceed with genetic testing will receive standard clinical testing for their familial mutation or more extensive testing when clinically indicated At the conclusion of the pre-test telephone counseling session participants who wish to proceed directly to testing will have the process for testing explained by the genetic counselor and a test requisition form TRF including insurance information will be completed Upon completion of the TRF a DNA saliva collection kit will be sent via overnight mail to the participant After participants collect their DNA they mail the kit and all included paperwork to the lab in a pre-paid FedEx pack Targeted testing will be for the specific PV identified in their family and if Ashkenazi Jewish AJ also for the 3 BRCA founder mutations In rare instances participants may have a particularly complex family history and will be appropriate for broader multiplex testing This option will be explained by the genetic counselor during the telephone session
Telephone Genetic Counseling Disclosure Telephone disclosures will be delivered by the same board certified genetic counselors who provided pretest counseling Telephone disclosures will utilize our existing clinical disclosure protocol that includes result disclosure with comprehensive interpretation discussion of cancer risks and management options implications for family members referral to specialists as neededindicated Within a week of the disclosure session participants will be provided with a copy of their results pedigree and an individualized summary letter
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
Remarkably there have been no randomized trials focused on increasing use of guideline consistent genetic counseling and targeted testing Guided by the Informed Choice ICM and Health Belief Models HBM the investigators will conduct a randomized controlled trial of proactive Web-based pre-test education plus a streamlined telephone genetic information session WT vs usual care UC for unaffected FSDRs of PV carriers Web-based pre-counseling education followed by a streamlined telephone genetic information session will be proactively delivered Following counseling participants will have the option to proceed directly to targeted testing By proactively providing access to accurate genetic information and reducing barriers to genetic services WT is predicted to yield increased uptake of genetic counseling and testing
Aim 1 Evaluate the impact of web-based intervention plus brief telephone information WT vs Usual Care UC on uptake of genetic counseling and targeted genetic testing
Aim 2 Evaluate the impact of WT vs UC on psychosocial outcomes
Aim 3 Evaluate mechanisms and moderators of WT
Research Overview The aim of this RCT is to evaluate the efficacy of proactively delivered Web Pre-Test Education plus Streamlined Telephone Counseling WT for first- and second-degree relatives FSDRs of individuals who have recently received a positive BRCA test result ie probands The WT intervention is designed to facilitate access to genetic education and counseling foster informed decisions and reduce barriers to targeted genetic testing The primary hypotheses are that WT participants will have increased uptake of genetic counseling and targeted genetic testing relative to UC participants Eligible FSDRs will be contacted for a baseline assessment One-month following the baseline assessment all participating FSDRs will be randomized by family to either WT or UC FSDRs will be reassessed at 1- and 6-months post-randomization and probands will be reassessed at 6-months post-randomization to enumerate additional testing in the family
Identification and Enrollment Probands will be recruited within the clinical genetics programs at LCCC George Washington University GWU Geisinger Clinic and Dana Farber Cancer Institute DFCI through direct referrals from local cancer genetics programs MedStar Franklin Square Medical Center Sibley Hospital and Inova Schar Cancer Institute We will enroll probands who have received a positive BRCA test result within the prior 12-months At GLCCC and GWU we routinely obtain permission to recontact BRCA probands at the time of their test result disclosure At Geisinger Clinic and DFCI study staff will obtain and document participant permission to share contact information with the study team For participants referred by outside clinical providers Franklin Square Sibley and Inova the provider will obtain patient permission to share contact information with the study team We will also enroll self-referred probands who will be identified in two ways First we will advertise the study on social media FacebookInstagramGoogle FacebookInstagramGoogle users who click on the study advertisement will be taken to our study website where they can review basic study information or find contact information to reach the study team with any questions Those who wish to proceed can then go directly to our secure REDCap page where they can complete a brief eligibility screener Second we will recruit self-referred probands who receive positive test results from the Ambry Genetics genetic testing laboratory Patients who have received a positive BRCA1BRCA2 test result within the past 12-months through Ambry will be identified by Ambry Genetics Ambry Genetics will then provide study information to the ordering providers who will be asked to pass this information along wit a study invitation to their potentially eligible patients Patients who respond to the study invitation will then be taken to the REDCap screening page described above Eligible probands will be contacted for enrollment a minimum of one-month following disclosure and a maximum of 12-months At that time they will be asked for consent to access their genetic counselingtesting records and provide the names addresses and telephone numbers of all potentially eligible FSDRs Participating probands will be asked to inform all potentially eligible FSDRs about the planned study contact
After obtaining contact information potentially eligible FSDRs will be mailed a recruitment packet introductory letter study brochure informed consent document opt-out e-mailaddresstelephone number Two weeks later a research assistant will call all FSDRs who have not opted out of the study The RA will explain the study and answer any questions At enrollment participants will be informed that written consent is required prior to randomization They will also be informed of the randomization date and that they must complete their baseline survey before that date in order to participate in the study
Baseline Assessment Individuals who remain eligible and interested can complete the 20 minute baseline survey via telephone by a trained RA or electronically For those who do not return the consent document prior to the baseline an RA will use an IRB-approved verbal consent for telephone baselines or electronic consent for electronic baselines Written consent will be required prior to randomization
Randomization Following the baseline participants will be provided with a randomization date on which they will be contacted with their assignment Participants will be randomized by family to avoid contamination Randomization will take place 1 month after enrollment of the first FSDR in a family At that point FSDRs who have not completed a baseline will be ineligible for the study Participants will be informed of the randomization deadline upon enrollment On the randomization date participants will be notified by email or phone followed by a priority letter For WT participants this letter will contain log-in information website instructions For UC participants this letter will include a list of informational resources including a list of low-cost genetic counseling options
Interventions
Usual Care As part of standard clinical genetic counseling probands with a BRCA mutation are provided with an individualized summary letter that includes cancer risks management recommendations and options a family letter that identifies at-risk relatives and encourages them to share the test result with these relatives All participants in both arms will receive these standard materials As described above following randomization UC participants will be notified of their assignment and will receive a list of informational resources Of course they can pursue standard clinical genetic counseling on their own at any of our study sites or any other program
The WT Intervention The WT intervention includes Interactive Pre-Test Web-Education plus a streamlined telephone information session directly scheduled through the web site and for those who opt for testing a telephone genetic counseling disclosure session The WT pre-test Web component is designed to provide comparable information to a traditional genetic counseling session for an FSDR of a mutation carrier A detailed description of the content of the WT is described in the treatment plan below Participants will receive an individualized link to the website that is connected to their email address They will be able to create their own password the first time they access the website and then log back into the website in the future using their email address and created password The website has a forgot password option where participants can create a new password at any time The study will provide participants with a toll-free support number to call if they have any questions After reviewing the website participants will be provided with the option to schedule a brief telephone information session with a trained genetic research assistant This session will take approximately 15 minutes and is designed to supplement and reinforce the web-based information This session will be provided free of charge Participants can decline
Genetic Testing Genetic testing is not required as part of this study Any participants who proceed with genetic testing will receive standard clinical testing for their familial mutation or more extensive testing when clinically indicated At the conclusion of the pre-test telephone counseling session participants who wish to proceed directly to testing will have the process for testing explained by the genetic counselor and a test requisition form TRF including insurance information will be completed Upon completion of the TRF a DNA saliva collection kit will be sent via overnight mail to the participant After participants collect their DNA they mail the kit and all included paperwork to the lab in a pre-paid FedEx pack Targeted testing will be for the specific PV identified in their family and if Ashkenazi Jewish AJ also for the 3 BRCA founder mutations In rare instances participants may have a particularly complex family history and will be appropriate for broader multiplex testing This option will be explained by the genetic counselor during the telephone session
Telephone Genetic Counseling Disclosure Telephone disclosures will be delivered by the same board certified genetic counselors who provided pretest counseling Telephone disclosures will utilize our existing clinical disclosure protocol that includes result disclosure with comprehensive interpretation discussion of cancer risks and management options implications for family members referral to specialists as neededindicated Within a week of the disclosure session participants will be provided with a copy of their results pedigree and an individualized summary letter
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
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