Page 11 - Delaware Medical Journal - January/February 2019

CANCER CLINICAL TRIAL
PROTOCOL OF THE MONTH
ECOG-ACRIN EAQ152: COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Disclosure Genetic Education vs. 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.
The objectives of the trial are:
Primary Objective:
•Primary Intervention Study: RCT (Step 1)
To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to:
a) Increase knowledge (genetic knowledge and knowledge of test benefits and limitations)
b) Decrease distress (anxiety, depression and cancer-specific worry) compared to usual care services in patients undergoing tumor profiling for advanced cancer
Secondary Objective:
• Primary Intervention Study: RCT (Step 1)
To evaluate potential moderators suggested by the SRTHB (e.g. test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in:
a) Knowledge of genetic disease and test benefits and limitations
b) Distress in patients undergoing tumor profiling for advanced cancer
Exploratory Objectives:
• Primary Intervention Study: RCT (Step 1)
To explore:
a) Satisfaction and regret/disappointment related to tumor genetic test results
b) How to better deliver tumor genetic test results and germline information in the future Secondary Genetic Counseling Substudy (Step 2). Please contact Zohra and Kendra Flores Eligibility
• Patients must be registered to the first screening step (Step 0) for the NCI-MATCH trial (EAY131) OR must be having tumor profiling for advanced cancer performed at or ordered by one of the select expansion sites.
• Patients must speak English.
• Patients must have web and e-mail access. NOTE: funding constraints for the costs associated with paper-based surveys.
• Patients in the MATCH trial must have not received his/her MATCH tumor genetic test results to be eligible to participate in COMET’s RCT. Non-MATCH expansion site patients must have not received his/her results from tumor profile genetic testing to be eligible to participate in the COMET’s RCT.
Treatment: Complete Baseline Survey
STEP 1 Arm A: Post-education survey (T1): 1-2 weeks after completion of T01.
STEP 1 Arm B: Post-education survey (T1): 1-2 weeks after completion of T01.
Screening participant (patient) receives treatment assignment results and/or tumor molecular profile results from their research/clinical team/treating physician.
Post-disclosure survey (T2): Within 3 days from receipt of results
Three-month survey (T3): 3 months after receipt of results. Usual care (Arm B) participants provided access to online genetic education.
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | January/February 2019 | Vol. 91 | No. 1 11