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

2016-07-06 23:08:21 | BioPortfolio

Summary

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 and remote genetic counseling before receiving tumor profiling results may increase genetic knowledge and reduce distress for patients with advanced cancer.

Description

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Conditions

Advanced Malignant Neoplasm

Intervention

Counseling, Genetic Counseling, Genetic Testing, Internet-Based Intervention, Survey Administration

Location

ECOG-ACRIN Cancer Research Group
Philadelphia
Pennsylvania
United States
19103

Status

Not yet recruiting

Source

Eastern Cooperative Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-06T23:08:21-0400

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