Using a Novel Lay Patient Navigation Model to Improve Cascade Testing Rates for Hereditary Cancer Syndromes in Black Patients and Their Family Members

N
Nawal Kassem

Primary Investigator

Enrolling By Invitation
18-100 years
All
Phase N/A
44 participants needed
4 Locations

Brief description of study

What is the purpose of this study?
The purpose of this study is to improve genetic testing rates in families of Black patients who are found to have a hereditary cancer syndrome.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
All questionnaires will be delivered using REDCap. Questionnaires will be pushed electronically to participants at each timepoint by study staff.

Pink-4-Ever Ending Disparities (P4E), a local organization focused on breast cancer advocacy, education, research, and eliminating disparities for Black women, will assist in identifying patient navigators. These previously trained patient navigators will serve as patient “buddies” providing informal support and encouragement.  

Enrolled participants who are found to have a PGV in any cancer predisposition gene must have at least one ARR 18 years of age who they are willing to share genetic testing results with. Once a proband is enrolled, they will be assigned a “buddy” (intervention). With the help of the research team, the enrolled proband will supply a list of eligible first and second degree relatives. First degree ARR are the proband’s parents, siblings and children. Second degree ARR include the probannd’s half siblings, aunts, uncles, grandparents, nieces and nephews.  The buddy will make initial contact with the proband within 5 business days of enrollment and make three attempts via phone. The buddy and proband will create a plan for the proband to contact all eligible ARRs (this will be preferably done in person but may be accomplished by phone).

The buddy will then follow up with the proband every other week (or at a frequency agreed upon between proband and buddy) for 12 weeks. The goal of these check ins will be to establish whether the proband has contacted any ARRs, establish who was contacted and record reasons as to why each (if any) of the ARR were not contacted.
The proband will give buddy contact information to interested ARRs. The buddy’s role once contacted by an ARR is to provide encouragement to pursue genetic testing, facilitate enrollment on trial, and support the ARR in requesting genetic testing services. The buddy’s role may also include helping fascilitate contact with the study team and/or provider for any questions regarding genetic testing, answering survey questions.
The ARR and buddy may communicate via phone or in person as agreed upon by both parties. The buddy will be available for the ARR for the duration of the study or until genetic testing is complete. We will capture instances where an ARR undergoes genetic counseling but in whom genetic testing is not recommended immediately (mostly due to age).  Testing can then be performed by in person or telemedicine genetic counseling, or by mailed test kits to the ARR by the proband’s treatment provider, depending on what works best for the ARR.  

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hereditary Cancer Syndrome
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria -Proband
1.    Age  18 years old at time of informed consent
2.    Ability to provide informed consent
3.    Self-reported African American or Black
4.    Received a recommendation for germline genetic testing
5.    Have at least one at-risk living family member age  18 years who has not had genetic testing or informed of genetic testing result

Inclusion criteria- ARRs
    ARRs are identified per standard of care by the ordering provider.
1.    Must be a first or second degree relative of proband
2.    Age  18 years old at time of informed consent
3.    Ability to provide written informed consent
4.    Self-reported African American or Black


Updated on 01 Aug 2024. Study ID: CTO-IUSCCC-0812, 19749
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