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| Name | Class |
|---|---|
| National Society of Genetic Counselors | OTHER |
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This 2-arm prospective, randomized, controlled clinical trial compared outcomes of telephone genetic counseling (intervention) versus in-person genetic counseling (control) in an underserved, multilingual patient population referred for cancer genetic counseling at two North Texas safety-net hospitals.
The main question[s] it aims to answer are:
The overarching goal of this pilot prospective randomized controlled study is to compare patient-reported and clinical operations outcomes between in-person genetic counseling (IPGC - control) and telephone-based genetic counseling (TGC - intervention) in an indigent English or Spanish-speaking population seeking genetic counseling for hereditary cancer syndromes to create a framework for effective and efficient genetic service delivery in these populations nationally. General genetic education and principles will be conveyed through a standard genetic counseling session including a pre-test education video in both the TGC and IPGC arms. The primary project objectives are to compare the following outcomes between the IPGC and TGC study arms. Aim 1: Patient reported outcomes - A. Patient satisfaction with genetic counseling visit; B. Knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives. Secondary objectives for this aim are: 1. Patient ability to make informed choice; and 2. Genetic counseling-specific empowerment outcomes. Aim 2: Clinical outcomes - visit completion rate; Secondary objectives are: 1. Genetic testing completion rate; and 2. Genetic testing cancelation/failure rate. Investigators hypothesize that patients in the TGC arm will not have significant differences in knowledge, satisfaction, informed choice or genetic counseling-specific empowerment compared to the IPGC arm. Investigators also expect significantly increased visit completion rate and lower test completion rate in the TGC arm compared to the IPGC arm, but no significant difference in sample failure rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person genetic counseling | Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service. | ||
| Telephone genetic counseling | Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Knowledge Score | Measure change in knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives pre- and post- genetic counseling using the Multi-dimensional Model of Informed Choice (MMIC) scale knowledge score, with minimum and maximum scores of 0 and 8 respectively, and higher scores correlated with better knowledge | MMIC Survey administered within 7 days prior to and post-genetic counseling visit |
| Patient Reported Outcome of Patient Satisfaction | Measure patient-reported patient satisfaction with genetic counseling visit using the Genetic Counseling Satisfaction Scale (GCSS) scores, with minimum and maximum values of 6 and 30 respectively and higher scores correlated with higher satisfaction | GCSS survey administered within 7 days post-genetic counseling visit |
| Clinical Outcome Measure of Genetic Counseling Visit Completion | Measure difference in genetic counseling visit completion rate between study arms | Genetic counseling visit completion was evaluated daily, up to 13.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome of Genetic Counseling-specific Empowerment | Measure change in patient reported genetic counseling-specific empowerment pre and post-genetic counseling using the Genomic Outcome Scale (GOS) scores with minimum and maximum scores of 6 and 30 respectively and higher scores correlated with improved outcomes | GOS survey administered within 7 days prior to and post-genetic counseling visit |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals referred to genetic counseling as part of standard of care
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| Name | Affiliation | Role |
|---|---|---|
| Sara Pirzadeh-Miller, M.S. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health | Dallas | Texas | 75390 | United States |
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Vulnerable populations and patients referred to genetic counseling for surgical planning were excluded from the study and were not assigned to a study arm.
Between 2022 and 2023, adult patients referred for cancer genetic counseling at two cancer genetics clinics housed in two safety-net hospitals in North Texas were recruited for the study. Patients had to meet the following inclusion criteria: be age 18 or older; speak English or Spanish; be uninsured or have Medicaid; have no prior cancer genetic counseling or testing; and have internet access, a valid email, and a working telephone number. Patients were excluded if they met exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | In-person Genetic Counseling | Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service. |
| FG001 | Telephone Genetic Counseling | Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service. Telephone genetic counseling: genetic counseling service delivered audio-only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | In-person Genetic Counseling | Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service. |
| BG001 | Telephone Genetic Counseling |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 in Knowledge Score | Measure change in knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives pre- and post- genetic counseling using the Multi-dimensional Model of Informed Choice (MMIC) scale knowledge score, with minimum and maximum scores of 0 and 8 respectively, and higher scores correlated with better knowledge | Population who completed genetic counseling and all study surveys | Posted | Mean | Standard Deviation | score on a scale | MMIC Survey administered within 7 days prior to and post-genetic counseling visit |
|
This was a minimal risk study and adverse events data were not collected
Adverse Events not monitored/assessed. This was a minimal risk study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-person Genetic Counseling | Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service. |
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Use of non-validated instruments (Multi-dimensional Model of Informed Choice and Genomics Outcome Scale), higher drop-off rate of enrolled study participants (50% observed; 30% anticipated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sayoni Lahiri | UT Southwestern Medical Center | 214-645-2563 | sayoni.lahiri@utsouthwestern.edu |
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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 | Oct 15, 2021 | Feb 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Number of Participants That Made an Informed Choice | Participants' ability to make an informed choice is assessed by the number of participants that made an informed choice using the Multi-dimensional Model of Informed Choice composite tool that includes understanding of relevant knowledge (1-8 items-higher scores indicate greater knowledge), attitudes toward testing (1-5 items-higher scores represent more positive attitudes), and whether the test decision is congruent with personal values (positive or negative about testing in relation to whether testing was accepted or declined). | MMIC survey administered within 7 days post-genetic counseling and genetic testing uptake during scheduled genetic counseling appointment |
| Clinical Outcome Measure of Genetic Testing Completion | Measure genetic test completion rate between study arms | Sample for testing provided within 45 days of visit without sample failure |
Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service.
Telephone genetic counseling: genetic counseling service delivered audio-only
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | American Indian or Alaska Native; Asian; Black or African American; White, Hispanic or Latino; White, Non-Hispanic or Latino; Hispanic or Latino, NOS | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Preferred Language | Participant-reported preferred language (English, Spanish) | Count of Participants | Participants |
|
| Cancer Diagnosis | Participant-reported personal history of cancer diagnosis (Yes, No) | Count of Participants | Participants |
|
| Telephone Genetic Counseling |
Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service. Telephone genetic counseling: genetic counseling service delivered audio-only |
|
|
| Primary | Patient Reported Outcome of Patient Satisfaction | Measure patient-reported patient satisfaction with genetic counseling visit using the Genetic Counseling Satisfaction Scale (GCSS) scores, with minimum and maximum values of 6 and 30 respectively and higher scores correlated with higher satisfaction | Participants who completed genetic counseling and all study surveys | Posted | Mean | Standard Deviation | score on a scale | GCSS survey administered within 7 days post-genetic counseling visit |
|
|
|
| Primary | Clinical Outcome Measure of Genetic Counseling Visit Completion | Measure difference in genetic counseling visit completion rate between study arms | Participants who completed the Pre-Genetic Counseling Survey and were scheduled for genetic counseling (in-person or via telephone) through the study | Posted | Count of Participants | Participants | Genetic counseling visit completion was evaluated daily, up to 13.5 months |
|
|
|
| Secondary | Patient Reported Outcome of Genetic Counseling-specific Empowerment | Measure change in patient reported genetic counseling-specific empowerment pre and post-genetic counseling using the Genomic Outcome Scale (GOS) scores with minimum and maximum scores of 6 and 30 respectively and higher scores correlated with improved outcomes | Participants who completed genetic counseling and all study surveys | Posted | Mean | Standard Deviation | score on a scale | GOS survey administered within 7 days prior to and post-genetic counseling visit |
|
|
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| Secondary | Number of Participants That Made an Informed Choice | Participants' ability to make an informed choice is assessed by the number of participants that made an informed choice using the Multi-dimensional Model of Informed Choice composite tool that includes understanding of relevant knowledge (1-8 items-higher scores indicate greater knowledge), attitudes toward testing (1-5 items-higher scores represent more positive attitudes), and whether the test decision is congruent with personal values (positive or negative about testing in relation to whether testing was accepted or declined). | Participants who completed genetic counseling and all study surveys | Posted | Count of Participants | Participants | MMIC survey administered within 7 days post-genetic counseling and genetic testing uptake during scheduled genetic counseling appointment |
|
|
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| Secondary | Clinical Outcome Measure of Genetic Testing Completion | Measure genetic test completion rate between study arms | Sample failures/test cancellations amongst participants who elected genetic testing | Posted | Count of Participants | Participants | Sample for testing provided within 45 days of visit without sample failure |
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| 0 |
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| EG001 | Telephone Genetic Counseling | Patients referred for standard of cancer genetic counseling are on the telephone with a genetic counselor for service. Telephone genetic counseling: genetic counseling service delivered audio-only | 0 | 0 | 0 | 0 | 0 | 0 |
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| Saliva sample; completed genetic test |
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| Saliva sample; incomplete genetic test |
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