NCT02823652

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

COMET - Communication and Education in Tumor Profiling: A Randomized Study of Pre-Disclosure 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

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

• Advanced Malignant Neoplasm
• Locally Advanced Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	standard genetic education	Undergo usual care
OTHER	Genetic Counseling	Complete remote counseling
OTHER	Genetic Testing	Undergo germline testing
OTHER	Internet-Based Intervention	Complete on-line genetic education
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2016-10-25
• Primary completion: 2019-12-26
• Completion: 2019-12-26
• First posted: 2016-07-06
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

1 site across 1 country: United States