NCT Number: NCT05130606
This is a mixed-methods Hybrid Type 1 research design (efficacy study) in which we aim to conduct a two-arm randomized controlled trial and an Implementation Focused Process Evaluation of a culturally-targeted video and referral screening tool.
In this study, the investigators aim to evaluate the efficacy of a culturally targeted video previously developed by the research team vs. a Spanish-language fact sheet from an established group on enhancing genetic counseling and testing uptake and psychosocial outcomes in Latina women at risk for hereditary breast and ovarian cancer.
The investigators will test the video's efficacy while also gathering data on the implementation and future sustainability of using the Risk Screening Tool (RST) and video in community clinics.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Georgetown Lombardi Comprehensive Cancer Center, Washington D.C., District of Columbia, United States
The investigators previously developed and piloted a culturally targeted narrative video in Spanish to provide HBOC and GCT education to at-risk Latinas. The investigators expanded traditional approaches to address psychosocial barriers through risk messages designed to elicit emotional responses; emotions are often stronger predictors of behavior than cognition. Our video is responsive to Latinas' preferences, targets motivators, and addresses psychosocial barriers identified in our formative research.
In this study, the investigators aim to evaluate the efficacy of our video vs. a fact sheet from an established group on enhancing GCT uptake and psychosocial outcomes on a two-arm randomized controlled trial. The investigators will test the video's efficacy while also gathering data on the implementation and future sustainability of using an adapted Risk Screening Tool (RST) and video in community clinics.
The investigators will partner with community clinics and implement a Risk Screening Tool (RST) at their practice to identify women at risk of HBOC. Community clinic staff (N~32) will be asked to participate in a pre-implementation and a post-implementation focus group to assess implementation outcomes of integrating HBOC screening practices in their clinic. Through the community clinics, the investigators aim to recruit N~300 Latina women at risk for HBOC based on their personal or family history of cancer. Latina women at risk for HBOC will be randomized to a Video arm or Fact Sheet Arm. All participants in the randomized controlled trial will be offered genetic counseling and testing.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aim 1 and 2.
Aim 3.
Exclusion criteria
-
Participants randomized to the video arm will receive a link with a password by email or text message to watch the video, depending on participants' preference. Participants without internet access will receive a DVD. Participants will be instructed to watch the video alone with no interruptions. We will ask them not to share the link with others.
Participants will receive a PDF of the fact sheet by email, text message, or a printed fact sheet by mail depending on participants' preferences. The fact sheet includes information about genes, breast cancer, risk factors for HBOC, genetic counseling and testing, and resources.
Time frame: Change from the baseline survey to four months after baseline
Participants will self report whether they attended a genetic counseling session in the four months following their baseline survey. The study team will also have direct access to the genetic counseling company's records.
Time frame: Change from the baseline survey to four months after baseline
Participants will self report whether they completed a genetic test for hereditary cancer in the four months following their baseline survey. The study team will also have direct access to the genetic counseling company's records.
Time frame: Change from the baseline to two-week after baseline, and change from two-week follow up survey to four months after baseline
9-item Scale from Kasting et al, 2019. The scale has statements to which participants respond True, False, or I don't Know. The scale is scored based on the accuracy of responses. A higher score indicates higher knowledge. Scores range from 0-9.
Time frame: Change from the baseline to two-week after baseline
Change in self-efficacy about genetic counseling and testing will be measured by specific items from the Theory of Planned Behavior scale (Ajzen, 2002) on a scale from 1-7 -Not at all to 7- Extremely)
Time frame: Change from the baseline to two-week after baseline
Changes in beliefs and attitudes about genetic counseling and genetic testing. The outcome will be assessed by 22 items from a scale developed by Sussner, Jandorf, Thompson et al., 2012 in which participants respond to a Likert-type scale from 1 (completely disagree) to 7 (completely agree).
Time frame: Change from the baseline to two-week after baseline
Change in subjective norms about genetic counseling and testing will be measured by specific items from the Theory of Planned Behavior scale (Ajzen, 2002) on a scale from 1-Not at all to 7- Extremely)
Time frame: Change from the baseline to two-week after baseline
Scale items on a 7-point Likert-type response (from 1-strongly disagree to 7-strongly agree).
Time frame: At two weeks after baseline
Overall acceptability is measured on a 4-item self-reported scale ranging from 1 to 10, where 1 = not at all to 10 = highly
Time frame: At two weeks after baseline
Proportion of women who have watched/read the video or fact sheet at the two week follow up
Time frame: Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research. (e.g., What barriers and facilitators did you experience while implementing the RST?)
Time frame: Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.
Time frame: At the post implementation focus groups with community clinics adoption over the previous 48 months will be assessed
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.
Time frame: At the post implementation focus groups with community clinics sustainability of the screener based on their experience during the previous 48 months will be assessed
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.
Contact information is provided by the study sponsor or research team.
Georgetown University
Other
Testing a Narrative Intervention to Enhance Genetic Counseling and Testing
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05721326
Adnexal Diseases, Breast Cancer Female
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT03246841
Adnexal Diseases, Breast Diseases
Paris, France
View Trial DetailsNCT02786147
Adnexal Diseases, Breast Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT02302742
Adnexal Diseases, Breast Cancer
Hays, Kansas, United States
View Trial Details