Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. 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). (Step 1) II. To evaluate the efficacy of web-based pre-test 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.

Official Title
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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

Conditions
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Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm

Intervention / Treatment
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* Other: Counseling
* Other: Genetic Counseling
* Other: Genetic Testing
* Other: Internet-Based Intervention
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (internet-based intervention)<br>Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations. | Other: Internet-Based Intervention<br>* Complete on-line genetic education<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (usual care control)<br>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. | Other: Counseling<br>* Undergo usual care<br>* Other names: Counseling Intervention;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Group III (genetic counseling)<br>Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing. | Other: Genetic Counseling<br>* Complete remote counseling<br>Other: Genetic Testing<br>* Undergo germline testing<br>* Other names: Genetic Test;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change scores: State Inventory of the State-Trait Anxiety Index | Will measure anxiety before and after genetic education or usual care | Assessed at baseline and up to 14 days post-baseline | 
| Difference in change scores: Impact of Events Scale (IES) | Will measure cancer-specific distress before and after genetic education or usual care | Assessed at baseline and up to 14 days post-baseline | 
| Difference in change scores: Cancer Genetic Knowledge Scale | Will measure knowledge about genetic diseases and inherited diseases before and after genetic education or usual care | Assessed at baseline and up to 14 days post-baseline | 
| Difference in change scores: PROMIS emotional distress: anxiety | Will measure anxiety before and after genetic education or usual care | Assessed at baseline and up to 14 days post-baseline | 
| Differences in change scores: PROMIS emotional distress: depression | Will measure depression before and after genetic education or usual care | Assessed at baseline and up to 14 days post-baseline | 
| Proportion of substudy participants who complete both remote genetic counseling and germline testing | Will test whether the uptake rate (proportion of participants who complete both genetic counseling and germline testing) exceeds the null hypothesized rate of 50% | Assessed at substudy eligibility and within 3 days after germline testing or decline of germline testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with uptake of clinical germline testing | Knowledge about germline testing will be assessed before and after counseling | Assessed within 3 days of receiving germline testing results | 
| Factors associated with uptake of remote genetic counseling | Knowledge about the impact of receiving information about potential clinically significant incidental germline mutations will be evaluated. | Assessed within 3 days of receiving genetic counseling |