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

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.

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

standard genetic education

Genetic Counseling

Genetic Testing

Internet-Based Intervention

Survey Administration

Angela Bradbury

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.

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.

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

The associations between patient characteristics and whether a patient receives genetic counseling will be evaluated.

Cognitive and affective responses to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling will be evaluated.

Satisfaction and regret/disappointment related to tumor genetic test results will be evaluated.

How to better deliver tumor genetic test results and germline information in the future will be evaluated.

Behavioral responses (communication to others) to confirmatory germline testing in advanced cancer patients with potential clinically significant incidental germline mutation identified in tumor profiling will be evaluated.

Satisfaction and regret/disappointment related to genetic counseling service or germline genetic test results will be evaluated

There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and compared between the two arms (arms A and B) at Step 1.

Among participants who registered in the genetic counseling substudy (Step 2), the proportion of participants who completed remote genetic counseling will be reported. The proportion is defined as "the number of participants who completed remote genetic counseling divided by the number of participants who agreed to participate in the genetic counseling study".

There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

There are 4 items in the PROMIS - Depression questionnaire. The total score ranges between 4 and 20. Higher scores indicate more depression. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

There are 4 items in the PROMIS - Anxiety questionnaire. The total score ranges between 4 and 20. Higher scores indicate more anxiety. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

There are 14 items in the questionnaire of Impact of Events Scale (IES). The total score ranges between 0 and 70. Higher scores indicate more stress. The questionnaire was administered at baseline and post-genetic education. The change of scores from baseline to post-genetic education were calculated and interaction between arm and sex was evaluated.

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Adverse event data were not collected on this study.

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

Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing in Step 2.

Arm A (Step 1: Internet-based Intervention; Step 2: Genetic Counseling Substudy)

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.

Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing in Step 2.

Arm B (Step 1: Usual Care Control; Step 2: Genetic Counseling Substudy)

Patients who did not participate in the primary on-line genetic education study (Step 1) but meet the criteria for the remote counseling substudy. These patients will receive genetic counseling over the telephone and undergo germline testing in Step 2.

Arm C (Step 1: no Participation; Step 2: Genetic Counseling Substudy)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Study Statistician

Arm A (Step 1: Internet-based Intervention)

Arm B (Step 1: Usual Care Control)

Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.

Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education

Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education

Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education

Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education

Eligible patients who agreed to participate in Step 2 genetic counseling substudy

Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)

Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)

Male

Female

Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex

Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex

Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex

Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex

Factors Associated With Uptake of Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)

Cognitive and Affective Responses to Confirmatory Germline Testing (Step 2)

Satisfaction and Regret/Disappointment Related to Tumor Genetic Test Results

How to Better Deliver Tumor Genetic Test Results and Germline Information in the Future

Behavioral Responses to Confirmatory Germline Testing

Satisfaction and Regret/Disappointment Related to Genetic Counseling Service or Germline Genetic Test Results

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

Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing in Step 2. Not all patients in Step 1 will be eligible and willing to participate in Step 2.

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.

Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing in Step 2. Not all patients in Step 1 will be eligible and willing to participate in Step 2.

These are patients who did not participate in the primary on-line genetic education study (Step 1) but meet the criteria for the remote counseling substudy. These patients will receive genetic counseling over the telephone and undergo germline testing in Step 2.

Spots Global Cancer Trial Database for standard genetic education