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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-02253 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EAQ152 | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EAQ152 | Other Identifier | CTEP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Step 1: internet-based intervention) | Experimental | Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations. |
|
| Arm B (Step 1: usual care control) | Active Comparator | 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 | Experimental | Patients who meet the criteria for the remote counseling substudy will receive genetic counseling over the telephone and undergo germline testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard genetic education | Other | Undergo usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education | 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. | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education | 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. | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education | 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. | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Factors Associated With Uptake of Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2) | The associations between patient characteristics and whether a patient receives genetic counseling will be evaluated. | Assessed at baseline in Step 2 |
| Cognitive and Affective Responses to Confirmatory Germline Testing (Step 2) |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Bradbury | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34890045 | Derived | Bradbury AR, Lee JW, Gaieski JB, Li S, Gareen IF, Flaherty KT, Herman BA, Domchek SM, DeMichele AM, Maxwell KN, Onitilo AA, Virani S, Park S, Faller BA, Grant SC, Ramaekers RC, Behrens RJ, Nambudiri GS, Carlos RC, Wagner LI. A randomized study of genetic education versus usual care in tumor profiling for advanced cancer in the ECOG-ACRIN Cancer Research Group (EAQ152). Cancer. 2022 Apr 1;128(7):1381-1391. doi: 10.1002/cncr.34063. Epub 2021 Dec 10. |
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A total of 601 patients were enrolled between October 25, 2016 and March 31, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Step 1: Internet-based Intervention; Step 2: Genetic Counseling Substudy) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step 1: On-line Genetic Education Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2019 |
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| Genetic Counseling | Other | Complete remote counseling |
|
| Genetic Testing | Other | Undergo germline testing |
|
|
| Internet-Based Intervention | Other | Complete on-line genetic education |
|
| Survey Administration | Other | Ancillary studies |
|
| Assessed at baseline and up to 14 days post-baseline |
| Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (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". | Assessed at baseline at Step 2 |
| Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (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". | Assessed at baseline at Step 2 |
| Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex | 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. | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex | 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. | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex | 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. | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
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. |
| Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2 |
| Satisfaction and Regret/Disappointment Related to Tumor Genetic Test Results | Satisfaction and regret/disappointment related to tumor genetic test results will be evaluated. | Assessed within 3 days of tumor test results received |
| How to Better Deliver Tumor Genetic Test Results and Germline Information in the Future | How to better deliver tumor genetic test results and germline information in the future will be evaluated. | Assessed at baseline, within 3 days of genetic test results received, within 3 days of germline testing results received |
| Behavioral Responses to Confirmatory Germline Testing | 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. | Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2 |
| Satisfaction and Regret/Disappointment Related to Genetic Counseling Service or Germline Genetic Test Results | Satisfaction and regret/disappointment related to genetic counseling service or germline genetic test results will be evaluated | Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2 |
| FG001 | Arm B (Step 1: Usual Care Control; 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. Not all patients in Step 1 will be eligible and willing to participate in Step 2. |
| FG002 | Arm C (Step 1: no Participation; Step 2: Genetic Counseling Substudy) | 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. |
| Baseline Survey Completion |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Step 2: Genetic Counseling Substudy |
|
|
All patients enrolled on this study
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Step 1: Internet-based Intervention; Step 2: Genetic Counseling Substudy) | 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. |
| BG001 | Arm B (Step 1: Usual Care Control; 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. |
| BG002 | Arm C (Step 1: no Participation; 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and up to 14 days post-baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (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". | Eligible patients who agreed to participate in Step 2 genetic counseling substudy | Posted | Number | 95% Confidence Interval | Proportion of participants | Assessed at baseline at Step 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (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". | Eligible patients who agreed to participate in Step 2 genetic counseling substudy | Posted | Number | 95% Confidence Interval | Proportion of participants | Assessed at baseline at Step 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex | 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. | Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline) |
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| Other Pre-specified | Factors Associated With Uptake of Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2) | The associations between patient characteristics and whether a patient receives genetic counseling will be evaluated. | Not Posted | Assessed at baseline in Step 2 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cognitive and Affective Responses to Confirmatory Germline Testing (Step 2) | 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. | Not Posted | Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Satisfaction and Regret/Disappointment Related to Tumor Genetic Test Results | Satisfaction and regret/disappointment related to tumor genetic test results will be evaluated. | Not Posted | Assessed within 3 days of tumor test results received | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | How to Better Deliver Tumor Genetic Test Results and Germline Information in the Future | How to better deliver tumor genetic test results and germline information in the future will be evaluated. | Not Posted | Assessed at baseline, within 3 days of genetic test results received, within 3 days of germline testing results received | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Behavioral Responses to Confirmatory Germline Testing | 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. | Not Posted | Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Satisfaction and Regret/Disappointment Related to Genetic Counseling Service or Germline Genetic Test Results | Satisfaction and regret/disappointment related to genetic counseling service or germline genetic test results will be evaluated | Not Posted | Assessed at baseline, within 3 days of remote genetic counseling, within 3 days of germline testing results received, and 3 months after germline testing results received in Step 2 | Participants |
Adverse event data were not collected on this study.
Adverse event data were not collected on this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Step 1: Internet-based Intervention; Step 2: Genetic Counseling Substudy) | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Arm B (Step 1: Usual Care Control; 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Arm C (Step 1: no Participation; 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Statistical Office | 617-632-3012 | eatrials@jimmy.harvard.edu |
| Dec 21, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003376 | Counseling |
| D005817 | Genetic Counseling |
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D033142 | Genetic Services |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
Not provided
Not provided
| Other |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Arm C (Step 1: no Participation; 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. |
|
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| OG002 | Arm C (Step 1: no Participation; 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. |
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