Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm
Conditions
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.
Interventions
OTHERstandard genetic education
Undergo usual care
OTHERGenetic Counseling
Complete remote counseling
OTHERGenetic Testing
Undergo germline testing
OTHERInternet-Based Intervention
Complete on-line genetic education
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
ECOG-ACRIN Cancer Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) - 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Factors Associated With Uptake of Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2) | Assessed at baseline in Step 2 | The associations between patient characteristics and whether a patient receives genetic counseling will be evaluated. |
| Satisfaction and Regret/Disappointment Related to Genetic Counseling Service or Germline Genetic Test Results | 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 will be evaluated |
| Behavioral Responses to Confirmatory Germline Testing | 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 | 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. |
| How to Better Deliver Tumor Genetic Test Results and Germline Information in the Future | Assessed at baseline, within 3 days of genetic test results received, within 3 days of germline testing results received | How to better deliver tumor genetic test results and germline information in the future will be evaluated. |
| Satisfaction and Regret/Disappointment Related to Tumor Genetic Test Results | Assessed within 3 days of tumor test results received | Satisfaction and regret/disappointment related to tumor genetic test results will be evaluated. |
| Cognitive and Affective Responses to Confirmatory Germline Testing (Step 2) | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 601 patients were enrolled between October 25, 2016 and March 31, 2019.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 293 |
| 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. | 301 |
| 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. | 7 |
| Total | 601 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Step 1: On-line Genetic Education Study | Baseline survey not done | 58 | 64 | 7 |
| Step 2: Genetic Counseling Substudy | Ineligible | 2 | 0 | 0 |
| Step 2: Genetic Counseling Substudy | Other | 2 | 2 | 1 |
| Step 2: Genetic Counseling Substudy | Withdrawal by Subject | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm A (Step 1: Internet-based Intervention; Step 2: Genetic Counseling Substudy) | Arm B (Step 1: Usual Care Control; Step 2: Genetic Counseling Substudy) | Arm C (Step 1: no Participation; Step 2: Genetic Counseling Substudy) | Total |
|---|---|---|---|---|
| Age, Continuous | 65 years | 65 years | 62 years | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 0 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 286 Participants | 291 Participants | 6 Participants | 583 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 16 Participants | 1 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) White | 268 Participants | 274 Participants | 6 Participants | 548 Participants |
| Sex: Female, Male Female | 161 Participants | 168 Participants | 6 Participants | 335 Participants |
| Sex: Female, Male Male | 132 Participants | 133 Participants | 1 Participants | 266 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education | 1.43 score on a scale | Standard Deviation 4.31 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education | -0.80 score on a scale | Standard Deviation 3.63 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: Assessed at baseline and up to 14 days post-baseline
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education | -1.79 score on a scale | Standard Deviation 9.43 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education | -0.19 score on a scale | Standard Deviation 9.86 |
p-value: 0.11t-test, 2 sided
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.
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education | -0.32 score on a scale | Standard Deviation 2.33 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education | -0.55 score on a scale | Standard Deviation 2.24 |
p-value: 0.312t-test, 2 sided
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.
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education | 0.23 score on a scale | Standard Deviation 2.36 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education | -0.30 score on a scale | Standard Deviation 2.48 |
p-value: 0.035t-test, 2 sided
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.
Time frame: Assessed at baseline at Step 2
Population: Eligible patients who agreed to participate in Step 2 genetic counseling substudy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2) | 0.43 Proportion of participants |
| Arm B (Step 1: Usual Care Control) | Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2) | 0.25 Proportion of participants |
| Arm C (Step 1: no Participation; Step 2: Genetic Counseling Substudy) | Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2) | 0.57 Proportion of participants |
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.
Time frame: Assessed at baseline at Step 2
Population: Eligible patients who agreed to participate in Step 2 genetic counseling substudy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2) | 0.43 Proportion of participants |
| Arm B (Step 1: Usual Care Control) | Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2) | 0.5 Proportion of participants |
| Arm C (Step 1: no Participation; Step 2: Genetic Counseling Substudy) | Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2) | 0.71 Proportion of participants |
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.
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex | Male | 1.4 score on a scale | Standard Deviation 4 |
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex | Female | 1.5 score on a scale | Standard Deviation 4.5 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex | Male | -0.5 score on a scale | Standard Deviation 3.7 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education by Arm and Sex | Female | -1.1 score on a scale | Standard Deviation 3.6 |
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.
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex | Male | -0.9 score on a scale | Standard Deviation 8.6 |
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex | Female | -2.4 score on a scale | Standard Deviation 10 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex | Male | -1.5 score on a scale | Standard Deviation 10.3 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Impact of Events Scale (IES) From Baseline to Post-genetic Education by Arm and Sex | Female | 0.9 score on a scale | Standard Deviation 9.4 |
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.
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex | Male | -0.3 score on a scale | Standard Deviation 2.4 |
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex | Female | -0.3 score on a scale | Standard Deviation 2.3 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex | Male | -0.4 score on a scale | Standard Deviation 1.9 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety From Baseline to Post-genetic Education by Arm and Sex | Female | -0.6 score on a scale | Standard Deviation 2.5 |
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.
Time frame: Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
Population: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex | Male | 0.2 score on a scale | Standard Deviation 2.5 |
| Arm A (Step 1: Internet-based Intervention) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex | Female | 0.2 score on a scale | Standard Deviation 2.3 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex | Male | 0 score on a scale | Standard Deviation 2.3 |
| Arm B (Step 1: Usual Care Control) | Change of Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression From Baseline to Post-genetic Education by Arm and Sex | Female | -0.6 score on a scale | Standard Deviation 2.6 |
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Assessed at baseline in Step 2
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.
Time frame: Assessed at baseline, within 3 days of genetic test results received, within 3 days of germline testing results received
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
Time frame: 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
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.
Time frame: Assessed within 3 days of tumor test results received