Trial Outcomes & Findings for Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations (NCT NCT06212310)

Last Updated: 2024-12-06

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

419 participants

Primary outcome timeframe

MMIC Survey administered within 7 days prior to and post-genetic counseling visit

Results posted on

2024-12-06

Participant Flow

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.

Vulnerable populations and patients referred to genetic counseling for surgical planning were excluded from the study and were not assigned to a study arm.

Participant milestones

Participant milestones
Measure	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. Telephone genetic counseling: genetic counseling service delivered audio-only
Overall Study STARTED	212	207
Overall Study COMPLETED	100	101
Overall Study NOT COMPLETED	112	106

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	In-person Genetic Counseling n=100 Participants Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.	Telephone Genetic Counseling n=101 Participants 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	Total n=201 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	98 Participants n=5 Participants	100 Participants n=7 Participants	198 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	92 Participants n=7 Participants	181 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White, Hispanic or Latino	42 Participants n=5 Participants	44 Participants n=7 Participants	86 Participants n=5 Participants
Race/Ethnicity, Customized White, Non-Hispanic or Latino	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino, NOS	33 Participants n=5 Participants	21 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	22 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants	101 Participants n=7 Participants	201 Participants n=5 Participants
Preferred Language English	47 Participants n=5 Participants	55 Participants n=7 Participants	102 Participants n=5 Participants
Preferred Language Spanish	53 Participants n=5 Participants	46 Participants n=7 Participants	99 Participants n=5 Participants
Cancer Diagnosis Yes	35 Participants n=5 Participants	23 Participants n=7 Participants	58 Participants n=5 Participants
Cancer Diagnosis No	65 Participants n=5 Participants	78 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: MMIC Survey administered within 7 days prior to and post-genetic counseling visit

Population: Population who completed genetic counseling and all study surveys

Outcome measures

Outcome measures
Measure	In-person Genetic Counseling n=100 Participants Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.	Telephone Genetic Counseling n=101 Participants 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
Change in Knowledge Score	0.05 score on a scale Standard Deviation 1.37	-0.08 score on a scale Standard Deviation 1.51

PRIMARY outcome

Timeframe: GCSS survey administered within 7 days post-genetic counseling visit

Population: Participants who completed genetic counseling and all study surveys

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

Outcome measures

Outcome measures
Measure	In-person Genetic Counseling n=100 Participants Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.	Telephone Genetic Counseling n=101 Participants 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
Patient Reported Outcome of Patient Satisfaction	24.64 score on a scale Standard Deviation 5.38	25.27 score on a scale Standard Deviation 3.75

PRIMARY outcome

Timeframe: Genetic counseling visit completion was evaluated daily, up to 13.5 months

Population: Participants who completed the Pre-Genetic Counseling Survey and were scheduled for genetic counseling (in-person or via telephone) through the study

Measure difference in genetic counseling visit completion rate between study arms

Outcome measures

Outcome measures
Measure	In-person Genetic Counseling n=171 Participants Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.	Telephone Genetic Counseling n=146 Participants 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
Clinical Outcome Measure of Genetic Counseling Visit Completion	141 Participants	131 Participants

SECONDARY outcome

Timeframe: GOS survey administered within 7 days prior to and post-genetic counseling visit

Population: Participants who completed genetic counseling and all study surveys

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

Outcome measures

Outcome measures
Measure	In-person Genetic Counseling n=100 Participants Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.	Telephone Genetic Counseling n=101 Participants 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
Patient Reported Outcome of Genetic Counseling-specific Empowerment	-0.21 score on a scale Standard Deviation 5.34	0.86 score on a scale Standard Deviation 4.62

SECONDARY outcome

Timeframe: MMIC survey administered within 7 days post-genetic counseling and genetic testing uptake during scheduled genetic counseling appointment

Population: Participants who completed genetic counseling and all study surveys

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).

Outcome measures

Outcome measures
Measure	In-person Genetic Counseling n=100 Participants Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.	Telephone Genetic Counseling n=101 Participants 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
Number of Participants That Made an Informed Choice	39 Participants	53 Participants

SECONDARY outcome

Timeframe: Sample for testing provided within 45 days of visit without sample failure

Population: Sample failures/test cancellations amongst participants who elected genetic testing

Measure genetic test completion rate between study arms

Outcome measures

Outcome measures
Measure	In-person Genetic Counseling n=86 Participants Patients referred for standard of cancer genetic counseling are seen in-person with a genetic counselor for service.	Telephone Genetic Counseling n=81 Participants 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
Clinical Outcome Measure of Genetic Testing Completion Blood sample; completed genetic test	83 Participants	20 Participants
Clinical Outcome Measure of Genetic Testing Completion Blood sample; incomplete genetic test	0 Participants	3 Participants
Clinical Outcome Measure of Genetic Testing Completion Saliva sample; completed genetic test	3 Participants	40 Participants
Clinical Outcome Measure of Genetic Testing Completion Saliva sample; incomplete genetic test	0 Participants	18 Participants

Adverse Events

In-person Genetic Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Telephone Genetic Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sayoni Lahiri

UT Southwestern Medical Center

Phone: 214-645-2563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place