Reach and Engagement of GENetic Education, Risk Assessment, and TEsting Feasibility Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

This study will test a remote approach to help people who may be at higher risk for pancreatic cancer learn about and decide whether to get genetic testing and a blood test that looks for signs of several cancers (MCED testing). The study is focused on Black, Latino/a, and Medicaid-enrolled individuals who may have had less access to cancer genetics and early detection services. About 80 participants, who reside in Massachusetts, will be assigned by chance to receive either online education alone or online education plus a phone call with a trained educator from the Pancreatic Cancer Action Network (PanCAN). After the education, participants can choose whether or not to have genetic testing and/or MCED testing. The main goal is to learn whether this approach is practical to carry out, acceptable to participants, and delivered as planned. Participants will complete 3 surveys during study participation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 50 years or older OR 10 years younger than the earliest PDAC diagnosis in a family member

Current Medicaid enrollment and/or Black and/or Latino/a

Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if MCED screening test indicates possible malignancy

Living in the state of Massachusetts

Disqualifiers

Less than age 50 years or age not within 10 years of the earliest PDAC diagnosis in their family

Cancer diagnosis in the last 3 years (excluding non-melanoma skin cancers)

Currently pregnant

Insurance other than Medicaid or race/ethnicity other than Black or Latino/a

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telephone education session

    Behavioral

    Participants will receive a telephone call from a trained navigator at PanCAN to provide \~20mins of information about genetic testing and MCED testing.

  • Online educational materials

    Behavioral

    Participants will receive links to test information provided by the testing company.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Telephone education session plus online educational materialsExperimental treatment 2 interventions
Group B: Online educational materials onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of completion of genetic testing and MCED testing

The intervention will be feasible if at least 30% of enrolled participants complete germline genetic testing and at least 30% complete MCED testing.

Time frame
Within 6 months of randomization
2

Acceptability of the education delivery

Acceptability will be assessed using the 3-item Client Satisfaction Questionnaire-3 (CSQ-3), with a mean score of at least 3 indicating acceptable intervention acceptability.

Time frame
Within 6 months of the educational information
3

Fidelity of the intervention

Fidelity will be considered adequate if at least 90% of participants in the telephone arm complete a session in which at least 90% of the required educational contents is reviewed

Time frame
Assessed within 6 months of the education session

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Pancreatic Cancer Action Network

Collaborator

Exact Science Corporation

Collaborator

Dana-Farber Cancer Institute

Collaborator

Winn Career Development Award

Collaborator

This trial is not recruiting at the moment. You can still explore other options: