Trial Outcomes & Findings for Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video (NCT NCT04476654)

Results Overview

Our primary outcome will be for participants to receive genetic testing and counseling.Investigators will be able to see if participant has scheduled a genetic testing appointment within the VCU Health appointment system.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

3 months

Results posted on

2024-10-22

Participant Flow

Trained clinical coordinators recruited participants, administered surveys and abstracted information on genetic counseling and testing from participant medical records

The clinical research assistants consented interested patients . Following consent, women completed a baseline survey. Next, women were randomized into study arms.

Participant milestones

Participant milestones
Measure	Fact Sheet Arm Komen print materials about genetic counseling and testing will be given to women.	YouTube Video Arm Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD. YouTube Video Arm: Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.
Overall Study STARTED	29	28
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fact Sheet Arm n=29 Participants Komen print materials about genetic counseling and testing will be given to women.	YouTube Video Arm n=28 Participants Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD. YouTube Video Arm: Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.	Total n=57 Participants Total of all reporting groups
Age, Continuous	47.24 years STANDARD_DEVIATION 16.91 • n=5 Participants	49.50 years STANDARD_DEVIATION 13.38 • n=7 Participants	48.35 years STANDARD_DEVIATION 15.19 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Genetic Counseling Knowledge	7.69 units on a scale STANDARD_DEVIATION 1.75 • n=5 Participants	7.50 units on a scale STANDARD_DEVIATION 1.45 • n=7 Participants	7.60 units on a scale STANDARD_DEVIATION 1.60 • n=5 Participants
Self-Efficacy to Screen	14.38 units on a scale STANDARD_DEVIATION 1.21 • n=5 Participants	14.29 units on a scale STANDARD_DEVIATION 2.32 • n=7 Participants	14.33 units on a scale STANDARD_DEVIATION 1.83 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Our primary outcome will be for participants to receive genetic testing and counseling.Investigators will be able to see if participant has scheduled a genetic testing appointment within the VCU Health appointment system.

Outcome measures

Outcome measures
Measure	Fact Sheet Arm n=29 Participants Komen print materials about genetic counseling and testing will be given to women.	YouTube Video Arm n=28 Participants Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD. YouTube Video Arm: Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.
Rate of Genetic Counseling and Testing Uptake. Counseling	18 Participants	15 Participants
Rate of Genetic Counseling and Testing Uptake. Testing	7 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.

The investigators measured general knowledge about hereditary breast and ovarian cancer. GCT knowledge was ascertained using a 13 item scale developed by Erblich et al.'s (2005). Example items included "have you ever heard about genetic counseling for BRCA 1 and 2?"" and have yes/no or true/false options. Scores across the 13 item Knowledge scale were summed with a range of ( 0-13) where higher values indicated higher knowledge.

Outcome measures

Outcome measures
Measure	Fact Sheet Arm n=26 Participants Komen print materials about genetic counseling and testing will be given to women.	YouTube Video Arm n=26 Participants Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD. YouTube Video Arm: Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.
Knowledge Scale - Genetic Counseling and Testing Knowledge . Follow-up	7.79 score on a scale Standard Deviation 1.90	8.11 score on a scale Standard Deviation 1.55
Knowledge Scale - Genetic Counseling and Testing Knowledge . Baseline	7.69 score on a scale Standard Deviation 1.75	7.50 score on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.

The investigators measured participants self-efficacy in genetic counseling services.Self-efficacy was measured with 3 items on a 5-point likert-scale, with questions that was developed for this study. Example items include "how confident are you that you can cope with your risk of developing cancer?". Response options are on a 5-point likert scale ranging from not at all confident (1) and very confident (5). Scores across the 3- item scale were summed with a range of (3-15) where higher scores indicated higher self efficacy.

Outcome measures

Outcome measures
Measure	Fact Sheet Arm n=26 Participants Komen print materials about genetic counseling and testing will be given to women.	YouTube Video Arm n=26 Participants Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD. YouTube Video Arm: Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.
Self-efficacy Scale Follow-up	14.76 score on a scale Standard Deviation 0.91	14.21 score on a scale Standard Deviation 2.02
Self-efficacy Scale Baseline	14.38 score on a scale Standard Deviation 1.21	14.29 score on a scale Standard Deviation 2.32

Adverse Events

Fact Sheet Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

YouTube Video Arm

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

Dr. Vanessa Sheppard

Virginia Commonwealth University

Phone: 804-828-8892

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place