Trial Outcomes & Findings for Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer (NCT NCT02823652)
NCT ID: NCT02823652
Last Updated: 2024-02-28
Results Overview
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.
COMPLETED
NA
601 participants
Assessed at baseline and post-genetic education (about 1-2 weeks post-baseline)
2024-02-28
Participant Flow
A total of 601 patients were enrolled between October 25, 2016 and March 31, 2019.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Step 1: On-line Genetic Education Study
STARTED
|
293
|
301
|
7
|
|
Step 1: On-line Genetic Education Study
Baseline Survey Completion
|
235
|
237
|
0
|
|
Step 1: On-line Genetic Education Study
COMPLETED
|
235
|
237
|
0
|
|
Step 1: On-line Genetic Education Study
NOT COMPLETED
|
58
|
64
|
7
|
|
Step 2: Genetic Counseling Substudy
STARTED
|
9
|
4
|
7
|
|
Step 2: Genetic Counseling Substudy
Eligible Patients
|
7
|
4
|
7
|
|
Step 2: Genetic Counseling Substudy
COMPLETED
|
3
|
2
|
5
|
|
Step 2: Genetic Counseling Substudy
NOT COMPLETED
|
6
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
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
Withdrawal by Subject
|
2
|
0
|
1
|
|
Step 2: Genetic Counseling Substudy
Other
|
2
|
2
|
1
|
Baseline Characteristics
Pre-Test Genetic Education and Remote Genetic Counseling in Communicating Tumor Profiling Results to Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Step 1: Internet-based Intervention; Step 2: Genetic Counseling Substudy)
n=293 Participants
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 B (Step 1: Usual Care Control; Step 2: Genetic Counseling Substudy)
n=301 Participants
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 C (Step 1: no Participation; Step 2: Genetic Counseling Substudy)
n=7 Participants
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.
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=99 Participants
|
65 years
n=107 Participants
|
62 years
n=206 Participants
|
65 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
335 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
266 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
286 Participants
n=99 Participants
|
291 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
583 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
268 Participants
n=99 Participants
|
274 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
548 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=184 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=178 Participants
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 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.
|
|---|---|---|---|
|
Change of Scores on Cancer Genetic Knowledge Scale From Baseline to Post-genetic Education
|
1.43 score on a scale
Standard Deviation 4.31
|
-0.80 score on a scale
Standard Deviation 3.63
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=195 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=193 Participants
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 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.
|
|---|---|---|---|
|
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
|
-0.30 score on a scale
Standard Deviation 2.48
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=202 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=201 Participants
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 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.
|
|---|---|---|---|
|
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
|
-0.55 score on a scale
Standard Deviation 2.24
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline and up to 14 days post-baselinePopulation: Eligible patients who completed both baseline and post-genetic education questionnaires were included in the analysis.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=183 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=191 Participants
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 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.
|
|---|---|---|---|
|
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
|
-0.19 score on a scale
Standard Deviation 9.86
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline at Step 2Population: Eligible patients who agreed to participate in Step 2 genetic counseling substudy
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".
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=7 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=4 Participants
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 C (Step 1: no Participation; Step 2: Genetic Counseling Substudy)
n=7 Participants
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.
|
|---|---|---|---|
|
Proportion of Participants Who Complete Remote Genetic Counseling in the Genetic Counseling Substudy (Step 2)
|
0.43 Proportion of participants
Interval 0.1 to 0.82
|
0.5 Proportion of participants
Interval 0.07 to 0.93
|
0.71 Proportion of participants
Interval 0.29 to 0.96
|
PRIMARY outcome
Timeframe: Assessed at baseline at Step 2Population: Eligible patients who agreed to participate in Step 2 genetic counseling substudy
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".
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=7 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=4 Participants
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 C (Step 1: no Participation; Step 2: Genetic Counseling Substudy)
n=7 Participants
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.
|
|---|---|---|---|
|
Proportion of Participants Who Complete Germline Testing in the Genetic Counseling Substudy (Step 2)
|
0.43 Proportion of participants
Interval 0.1 to 0.82
|
0.25 Proportion of participants
Interval 0.01 to 0.81
|
0.57 Proportion of participants
Interval 0.18 to 0.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=184 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=178 Participants
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 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.
|
|---|---|---|---|
|
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 4.0
|
-0.5 score on a scale
Standard Deviation 3.7
|
—
|
|
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
|
-1.1 score on a scale
Standard Deviation 3.6
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=195 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=193 Participants
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 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.
|
|---|---|---|---|
|
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
|
0 score on a scale
Standard Deviation 2.3
|
—
|
|
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
|
-0.6 score on a scale
Standard Deviation 2.6
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=202 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=201 Participants
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 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.
|
|---|---|---|---|
|
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
|
-0.4 score on a scale
Standard Deviation 1.9
|
—
|
|
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
|
-0.6 score on a scale
Standard Deviation 2.5
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm A (Step 1: Internet-based Intervention)
n=183 Participants
Patients receive web-based genetic education consisting of general information about testing tumors for genetic mutations.
|
Arm B (Step 1: Usual Care Control)
n=191 Participants
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 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.
|
|---|---|---|---|
|
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
|
-1.5 score on a scale
Standard Deviation 10.3
|
—
|
|
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
|
0.9 score on a scale
Standard Deviation 9.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline in Step 2The associations between patient characteristics and whether a patient receives genetic counseling will be evaluated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Cognitive 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed within 3 days of tumor test results receivedSatisfaction and regret/disappointment related to tumor genetic test results will be evaluated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline, within 3 days of genetic test results received, within 3 days of germline testing results receivedHow to better deliver tumor genetic test results and germline information in the future will be evaluated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Behavioral 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 2Satisfaction and regret/disappointment related to genetic counseling service or germline genetic test results will be evaluated
Outcome measures
Outcome data not reported
Adverse Events
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)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60