Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer
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About
This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline mutations may increase genetic knowledge and reduce distress for patients with advanced cancer.
Full description
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to increase knowledge (genetic knowledge and knowledge of test benefits and limitations). (Step 1)
II. To evaluate the efficacy of web-based pre-disclosure genetic education (i.e. before receipt of tumor profile results) to decrease distress (anxiety, depression and cancer specific worry) compared to usual care services in patients undergoing tumor profiling for advanced cancer. (Step 1)
III. To evaluate the uptake of remote genetic counseling (Step 2)
IV. To evaluate the uptake of germline testing among advanced cancer patients with a potential clinically significant incidental germline mutation identified through tumor profiling in the Molecular Analysis for Therapy Choice (MATCH) trial. (Step 2)
SECONDARY OBJECTIVES:
I. To evaluate potential moderators suggested by the self-regulation theory of health behavior (SRTHB) (e.g. test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in knowledge of genetic disease and test benefits and limitations. (Step 1)
II. To evaluate potential moderators suggested by the SRTHB (e.g test result, sociodemographic factors, health literacy, baseline knowledge or distress) to changes in distress in patients undergoing tumor profiling for advanced cancer. (Step 1)
III. To evaluate factors associated with uptake of genetic counseling and germline testing. (Step 2)
IV. To evaluate cognitive, affective and behavioral (communication to relatives) responses to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling. (Step 2)
OUTLINE:
STEP I (PRIMARY INTERVENTION STUDY): Participants are randomized to 1 of 2 arms.
ARM A: Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
ARM B: Patients receive standard genetic education consisting of conversations with the treating physicians, interaction with and information from the clinical staff, and information from usual resources about testing for genetic mutations.
STEP II (SECONDARY GENETIC COUNSELING SUBSTUDY):
Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
After completion of study treatment, patients are followed up periodically.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
- (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
Trial design
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Interventional model
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601 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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