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

Not Applicable

Completed

Conditions: Locally Advanced Malignant Neoplasm
Advanced Malignant Neoplasm

Interventions: Other: Genetic Counseling
Other: standard genetic education
Other: Internet-Based Intervention
Other: Survey Administration
Other: Genetic Testing

Registration Number: NCT02823652

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 601

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B (Step 1: usual care control)	Survey Administration	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 2 - genetic counseling	Genetic Counseling	Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
Arm A (Step 1: internet-based intervention)	Survey Administration	Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
Arm B (Step 1: usual care control)	standard genetic education	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.
Arm A (Step 1: internet-based intervention)	Internet-Based Intervention	Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
Step 2 - genetic counseling	Genetic Testing	Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.
Step 2 - genetic counseling	Survey Administration	Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing.

Primary Outcome Measures

Name	Time	Method
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education	Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)	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.
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education	Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)	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.
Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)	Assessed at baseline at Step 2	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".
Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)	Assessed at baseline at Step 2	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".
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education	Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)	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.
Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education	Assessed at baseline and up to 14 days post-baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex	Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)	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.
Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex	Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)	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.
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex	Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)	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.
Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex	Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)	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.