Genetic education for genetic testing of tumors

COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Test Genetic Education v. Usual Care in Tumor Profiling for Advanced Cancer and a Pilot Study of Remote Genetic Counseling for Participants With Potential Germline Mutations Identified on Tumor Profiling

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Ford, Elizabeth; Frankos, Marie; Jobson, Gillian S; Morales, Leticia; Quintiliani, Jennifer; Rompola, Melissa

    Trial Phone: 321.841.7413 ; 321.841.7303 ; 321.841.2285 ; 321.841.6696 ; 321.843.2026 ; 321.841.7022

  • IRB No: EAQ152

    Protocol Abbrev: CIRB EAQ152

    Principal Investigator: Rebecca L. Moroose, MD

    Sub Investigators: Avgeropoulos, Nicholas MD; Baidas, Said MD; Cuesta, Ana MD; Hajdenberg, Julio MD; Johnson, Tirrell MD; Kayaleh, Omar MD; Landau, Daniel MD; Maddipatla, Sreeram MD; Neely, Lindsey ARNP; Rostorfer, Regan MD; Sarriera, Jose MD; Schimp, Veronica DO; Shah, Nikita MD; Thomas, Sajeve MD; Tseng, Jennifer MD

    Age Group: Adult

    Secondary Protocol No: COMET

    Applicable Disease Sites: Breast, Melanoma, GI, Lung, Neuro, GYN, Head and Neck, GU, Hem

    ClinicalTrials.gov ID: NCT02823652

  • Objective

    To evaluate the efficacy of web-based pre-test genetic education (i.e. before receipt of tumor profile results) to increase knowledge (genetic knowledge and knowledge of test benefits and limitations).

  • Key Eligibility

    (STEP 1) - PRIMARY INTERVENTION STUDY (RANDOMIZED CONTROLLED TRIAL [RCT]):
    •  Patients must be registered to the first screening step (Step 0) for the National Cancer Institute (NCI)-MATCH trial (EAY131)
    •  Patients must speak English and have an adequate ability to view a website (primary intervention study)
    •  (STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:
    •  Patients must have a potential germline mutation, as determined by the NCI-MATCH tumor profiling assay
    •  Patients must be able to speak English and hear by phone