Breast CancerNCT04476654
Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video
A study testing YouTube Video Arm in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Genetic counseling and testing (GCT) provides invaluable information for women who are at-risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT compared to White women. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- YouTube Video Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Must be at high risk for hereditary breast or ovarian cancer
- Must identify as Black/African American
- Must be a woman
- Referred to a genetic counselor for the purpose of being high risk of carrying a hereditary breast and/or ovarian cancer mutation
- Genetic Counselors:
Show all 9Show fewer
- Must be at least 18 years of age
- Must be qualified
- Must be approved by the PI
Who cannot join
- Under the age of 18
- Race other than Black/African American
- Do not gave a high risk for hereditary breast or ovarian cancer
- Genetic Counselors:
- Under 18
- Not qualified
- Not approved by the PI
Trial locations and contacts
1 site in 1 country.
About this study
Genetic counseling and testing (GCT) provides invaluable information for women who are at-risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT compared to White women. This study will conduct a RCT to test the efficacy of a culturally-tailored theory-based video intervention aimed to address key psychosocial factors (emotions, ambivalence) to improve uptake of genetic counseling in Black women at increased risk of HBOC. Findings from this study may offer an opportunity to engage at-risk Black women regarding genetic counseling through a multi-center trial and ultimately address the disparity in genetic counseling uptake that exists between Black and White women.
Read the detailed description
Breast cancer (BC) is the most frequently diagnosed cancer in African American women (hereafter referred to as "Black") and their cancer mortality is higher than other racial/ethnic groups in the United States (US). Compared to non-Hispanic Whites, Black women are diagnosed younger and with more advanced breast cancer. When diagnosed with BC, Black women present more often with triple-negative breast cancer (TNBC) an aggressive disease defined by the absence of estrogen and progesterone receptors, and human epidermal growth factor (HER)-2 expression. TNBC has been associated with pathogenic BRCA1 variants. Racial disparities also exist for women with ovarian cancer, the most lethal of the gynecologic cancers. Among women with advanced ovarian cancers up to 21% are associated with inherited pathogenic mutations the most common of which is BRCA1. Women who carry a pathogenic BRCA variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer risk of up to 44%. The National Comprehensive Cancer Network (NCCN) recommends referral for Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling and testing (GCT) for women at risk of carrying a BRCA PV. GCT provides women with information needed to make informed decisions to reduce their cancer risk, yet Black women are less likely to use GCT than whites. There is a dearth of interventions to address this issue and produced results are mixed and modest. Awareness of a positive result can inform treatment decisions for cancer patients and risk management in survivors or women unaffected with cancer.
Reasons for the lower uptake of GCT in Black women are multi-factorial and include access, knowledge, psycho-social factors, and may vary by cancer status (affected versus unaffected). There are substantial scientific gaps regarding effective interventions to address the sub-optimal uptake of GCT in Black women. To be effective, GCT interventions should be anchored within the needs and cultural values of their audience. While improving knowledge about GCT and one's individual risks is important, interventions that only address knowledge may not enhance uptake, as risk information evokes emotional reactions that are often stronger predictors of behaviors than cognitive factors.
Notably, this team has identified factors that contribute to Black women's uptake of GCT. In preliminary studies, researchers found that self-efficacy in making decisions about GCT and medical mistrust were associated with GCT uptake. Low knowledge among Black BC survivors at risk of HBOC has also been found. Anticipated negative emotions to GCT have been associated with lower uptake. Similar studies suggest that Black women report emotions related to fear of being singled out, and the fear of being hopeless. Because most interventions have focused solely on knowledge or access, the proposed study makes a considerable shift in the field by additionally targeting emotions, ambivalence, and developing a media-based risk communication tool.
Guided by two evidenced-based theories and preliminary data, this will be a two-phased mixed methods study. In Phase I (months 1-7), formative research and preliminary data will be used to develop the script for the GCT video. The script will be reviewed by GCT experts (n=4) and piloted in two focus groups (n=16) followed by a staged reading to make final refinements. In Phase II (months 8-24), a two-arm randomized trial (RCT) to compare GCT uptake and psycho-social outcomes between 50 at-risk Black women receiving printed Susan G. Komen developed GCT literature (control group) (n=25) or a tailored YouTube video intervention (n=25) will be conducted . All women will be referred to an appointment scheduler who will assist them with making an appointment with a genetic counselor. Participants will complete a baseline survey and follow-up assessment. The primary outcome will be genetic counseling uptake and receipt testing at 3-months will be explored. Specific aims are to:
Aim 1. Develop a YouTube video using a formative data for Black women at risk for HBOC.
Aim 2. Evaluate the efficacy of the intervention by comparing outcomes between women in the YouTube intervention arm vs. control group arm. H.2.1. Women in the intervention group (vs control group) will have higher genetic counseling uptake. H.2.2. Women in the intervention group (vs control group) will report higher knowledge, higher self-efficacy, higher endorsement of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most women (≥75%) will be satisfied with the experimental intervention.
Enhancing GCT in at-risk populations is a national priority. Given trends towards panel testing and other genomic advances, there is potential for existing disparities to widen. Findings will inform new strategies for behavioral interventions for Black women and a larger trial. If successful, the intervention could be easily disseminated broadening its reach to affected and unaffected women.
This study meets the Healthy People 2020 goals to enhance GRCA in at-risk populations, and the national priorities to increase diversity in genetics research participation and incorporate emotions into cancer research. Findings will inform new strategies for behavioral interventions targeting African-Americans in a larger trial.
- Conditions
- Breast Cancer
- Being tested
- YouTube Video Arm
- Keywords
- genetic counseling and testing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouTube Video ArmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fact Sheet Arm | No intervention | Komen print materials about genetic counseling and testing will be given to women. |
| YouTube Video Arm | Active comparator | Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD. Receives: Behavioral: YouTube Video Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Genetic Counseling and Testing Uptake.
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.
Measured: 3 months
Secondary outcomes (2)
Knowledge Scale - Genetic Counseling and Testing Knowledge .
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.
Measured: Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.
Self-efficacy Scale
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.
Measured: Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Nov 2021
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vanessa Sheppard, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476654
- Sponsor's protocol ID
- MCC-19-15167
- Other IDs
- HM20016234, NCI-2019-04689, R21CA236496
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2020
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video
- ClinicalTrials.gov ID
- NCT04476654
- Acronym / sponsor ID
- MCC-19-15167
- Conditions
- Breast Cancer
- Keywords
- genetic counseling and testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genetic counseling and testing (GCT) provides invaluable information for women who are at-risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT compared to White women. This study will conduct a RCT to test the efficacy of a culturally-tailored theory-based video intervention aimed to address key psychosocial factors (emotions, ambivalence) to improve uptake of genetic counseling in Black women at increased risk of HBOC. Findings from this study may offer an opportunity to engage at-risk Black women regarding genetic counseling through a multi-center trial and ultimately address the disparity in genetic counseling uptake that exists between Black and White women.
Detailed description
Breast cancer (BC) is the most frequently diagnosed cancer in African American women (hereafter referred to as "Black") and their cancer mortality is higher than other racial/ethnic groups in the United States (US). Compared to non-Hispanic Whites, Black women are diagnosed younger and with more advanced breast cancer. When diagnosed with BC, Black women present more often with triple-negative breast cancer (TNBC) an aggressive disease defined by the absence of estrogen and progesterone receptors, and human epidermal growth factor (HER)-2 expression. TNBC has been associated with pathogenic BRCA1 variants. Racial disparities also exist for women with ovarian cancer, the most lethal of the gynecologic cancers. Among women with advanced ovarian cancers up to 21% are associated with inherited pathogenic mutations the most common of which is BRCA1. Women who carry a pathogenic BRCA variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer risk of up to 44%. The National Comprehensive Cancer Network (NCCN) recommends referral for Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling and testing (GCT) for women at risk of carrying a BRCA PV. GCT provides women with information needed to make informed decisions to reduce their cancer risk, yet Black women are less likely to use GCT than whites. There is a dearth of interventions to address this issue and produced results are mixed and modest. Awareness of a positive result can inform treatment decisions for cancer patients and risk management in survivors or women unaffected with cancer.
Reasons for the lower uptake of GCT in Black women are multi-factorial and include access, knowledge, psycho-social factors, and may vary by cancer status (affected versus unaffected). There are substantial scientific gaps regarding effective interventions to address the sub-optimal uptake of GCT in Black women. To be effective, GCT interventions should be anchored within the needs and cultural values of their audience. While improving knowledge about GCT and one's individual risks is important, interventions that only address knowledge may not enhance uptake, as risk information evokes emotional reactions that are often stronger predictors of behaviors than cognitive factors.
Notably, this team has identified factors that contribute to Black women's uptake of GCT. In preliminary studies, researchers found that self-efficacy in making decisions about GCT and medical mistrust were associated with GCT uptake. Low knowledge among Black BC survivors at risk of HBOC has also been found. Anticipated negative emotions to GCT have been associated with lower uptake. Similar studies suggest that Black women report emotions related to fear of being singled out, and the fear of being hopeless. Because most interventions have focused solely on knowledge or access, the proposed study makes a considerable shift in the field by additionally targeting emotions, ambivalence, and developing a media-based risk communication tool.
Guided by two evidenced-based theories and preliminary data, this will be a two-phased mixed methods study. In Phase I (months 1-7), formative research and preliminary data will be used to develop the script for the GCT video. The script will be reviewed by GCT experts (n=4) and piloted in two focus groups (n=16) followed by a staged reading to make final refinements. In Phase II (months 8-24), a two-arm randomized trial (RCT) to compare GCT uptake and psycho-social outcomes between 50 at-risk Black women receiving printed Susan G. Komen developed GCT literature (control group) (n=25) or a tailored YouTube video intervention (n=25) will be conducted . All women will be referred to an appointment scheduler who will assist them with making an appointment with a genetic counselor. Participants will complete a baseline survey and follow-up assessment. The primary outcome will be genetic counseling uptake and receipt testing at 3-months will be explored. Specific aims are to:
Aim 1. Develop a YouTube video using a formative data for Black women at risk for HBOC.
Aim 2. Evaluate the efficacy of the intervention by comparing outcomes between women in the YouTube intervention arm vs. control group arm. H.2.1. Women in the intervention group (vs control group) will have higher genetic counseling uptake. H.2.2. Women in the intervention group (vs control group) will report higher knowledge, higher self-efficacy, higher endorsement of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most women (≥75%) will be satisfied with the experimental intervention.
Enhancing GCT in at-risk populations is a national priority. Given trends towards panel testing and other genomic advances, there is potential for existing disparities to widen. Findings will inform new strategies for behavioral interventions for Black women and a larger trial. If successful, the intervention could be easily disseminated broadening its reach to affected and unaffected women.
This study meets the Healthy People 2020 goals to enhance GRCA in at-risk populations, and the national priorities to increase diversity in genetics research participation and incorporate emotions into cancer research. Findings will inform new strategies for behavioral interventions targeting African-Americans in a larger trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Fact Sheet Arm | No intervention | –Komen print materials about genetic counseling and testing will be given to women. |
| YouTube Video Arm | Active comparator | Behavioral: YouTube Video ArmParticipants in this arm will receive the culturally tailored video either via a Youtube link or a DVD. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be at least 18 years of age
- Must be at high risk for hereditary breast or ovarian cancer
- Must identify as Black/African American
- Must be a woman
- Referred to a genetic counselor for the purpose of being high risk of carrying a hereditary breast and/or ovarian cancer mutation
Key exclusion criteria (7 listed)
- Under the age of 18
- Race other than Black/African American
- Do not gave a high risk for hereditary breast or ovarian cancer
- Under 18
- Not qualified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YouTube Video ArmParticipants (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. | Behavioural | YouTube Video Arm |
Primary outcome
Rate of Genetic Counseling and Testing Uptake.
Time frame: 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.
2 secondary outcomes
Knowledge Scale - Genetic Counseling and Testing Knowledge .
Time frame: Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.
Self-efficacy Scale
Time frame: Baseline was collected up to 48 hours from the start of the intervention and the follow-up was assessed within 48 hours post-intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Sheppard, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YouTube Video Arm in people with Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Genetic Counseling and Testing Uptake. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.