The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families

Family Member:

If you agree to take part in this study:

- You will use your online account to access a FamilyCONNECT website in order to
communicate with family members about a genetic mutation that has been found in your
family.

- On the FamilyCONNECT website, you will:

- Provide additional information about your family history. This could take up to 20
minutes to complete.

- Print an updated copy of the family tree that describes your family.

- List other family members who may share this genetic mutation risk, then choose—for
each family member—whether you want us to share information about the family's
genetic mutation.

- Provide contact information for each family member who you want us to contact.

This is an investigational study.

Up to 130 study participants who have the gene mutation, and their interested family members
(up to 10,000 total participants), will be enrolled in this research study. All will be
enrolled at MD Anderson.

MD Anderson Patient:

If you agree to take part in this study:

- You will be asked to complete a family history questionnaire online, which should take
about 20 minutes to complete. If your family history questionnaire has already been
completed with an MD Anderson genetic counselor, the study staff will use this
information in the study.

- You will create an account to access the online site called FamilyCONNECT that allows
you to communicate with family members about your genetic mutation and their risk of
having this mutation as well.

- On that online site, you will:

- Create a user name and password

- Provide additional information about your family history.

- Print a family tree about your family.

- Choose—for each family member—whether you want us to share information about your
genetic mutation.

- Provide contact information for each family member who you want us to contact.

Your personal health information will be collected from your medical record while you are on
study. In the future, the study staff will continue to gather health (including genetic)
information about you from the institutions for which you have signed the release of medical
records.

Length of Study:

There is no end date planned for the collection of your health information on this study.

This is an investigational study.

Up to 130 study participants who have the gene mutation, and their interested family members
(up to 10,000 total participants), will be enrolled in this research study. All will be
enrolled at MD Anderson.

Non-MD Anderson Patient:

If you agree to take part in this study:

- You will create an account to access the online site called FamilyCONNECT that allows
you to communicate with family members about your genetic mutation and their risk of
having this mutation as well

- On that online site, you will:

- Create a user name and password

- Provide information about your family history, which should take you about 20
minutes to complete.

- Print a family tree about your family.

- Choose—for each family member—whether you want us to share information about your
genetic mutation.

- Provide contact information for each family member who you want us to contact.

- You will be asked to sign the release of your medical records, including your health
information, genetic testing information, and treatments that may have been performed.
Your personal health information will also be collected from your medical record while
you are on study. In the future, the study staff will continue to gather health
(including genetic) information about you from the institutions for which you have
signed the release of medical records.

Length of Study:

There is no end date planned for the collection of your health information on this study.

This is an investigational study.

Up to 130 study participants who have the gene mutation, and their interested family members
(up to 10,000 total participants), will be enrolled in this research study. All will be
enrolled at MD Anderson.

Inclusion Criteria:

1. Individuals who have been diagnosed with a hereditary cancer-causing mutation.
Individuals may be identified through clinical testing as patients at MD Anderson or
patients whose mutation was identified at an outside institution who contact the
registry.

2. Individuals that have clinical suspicion for syndromic cancer susceptibility, but in
whom mutational testing has been nondiagnostic (depending on condition in question,
nondiagnostic testing may be as little as 10%, as in FAP, or as high as 70% in
suspected hereditary diffuse gastric cancer or HDGC).

3. At-risk family members (older than 18 years of age) of individuals with a cancer
causing mutation or of individuals with nondiagnostic testing notwithstanding presence
of likely syndromic cancer. Such patients will in most cases not be MD Anderson
patients. Note: The enrollment, consenting, and evaluation process anticipates and
addresses this, as outlined below in section 4.0 Research Plan and Methods.

Exclusion Criteria:

1. Index patients who test negative for a cancer causing mutation, except for those
agreeing to provide family history (FH) that is informative for at-risk individuals
when no other source of such information is available.

2. Patients who are unwilling or are unable to provide informed consent.