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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-25

Study Completion Date

2019-12-26

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.

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Detailed Description

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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.

Conditions

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Advanced Malignant Neoplasm Locally Advanced Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm A (Step 1: internet-based intervention)

Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Complete on-line genetic education

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm B (Step 1: usual care control)

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.

Group Type ACTIVE_COMPARATOR

standard genetic education

Intervention Type OTHER

Undergo usual care

Survey Administration

Intervention Type OTHER

Ancillary studies

Step 2 - genetic counseling

Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.

Group Type EXPERIMENTAL

Genetic Counseling

Intervention Type OTHER

Complete remote counseling

Genetic Testing

Intervention Type OTHER

Undergo germline testing

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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standard genetic education

Undergo usual care

Intervention Type OTHER

Genetic Counseling

Complete remote counseling

Intervention Type OTHER

Genetic Testing

Undergo germline testing

Intervention Type OTHER

Internet-Based Intervention

Complete on-line genetic education

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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counseling Counseling Intervention genetic analysis Genetic Examination Genetic Test

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No