Clinical trial NCT05130606: CONTIGO - Informing Latinas About HBOC Risk
Official title: CONTIGO - Informing Latinas About HBOC Risk: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer
Keywords: Breast cancer
Ovarian cancer
Hereditary cancer
Latinas
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Virginia Commonwealth University
First posted: 2021-11-23
Enrollment: 332
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type 1 research design (efficacy study). Two arm randomized controlled trial and Implementation Focused Process Evaluation
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Aim 1 and 2.

* Self-identify as a Latina woman
* Be 18 years old or older
* Be able to provide informed consent
* Be fluent in Spanish
* Meet NCCN criteria to be considered for genetic cancer risk assessment for HBOC, whether by a personal history of cancer or family history of cancer
* No previous participation in genetic counseling or testing for hereditary breast and ovarian cancer risk
* No other family members are participating in this study
* Have not participated in any previous studies involving interventions about HBOC or GCT

Aim 3.

* Be 18 years old or older
* Be fluent in English or Spanish
* Have a role in the partner community clinic as either a) full-time or part-time employee b) intern c) volunteer

Exclusion Criteria:

-

Primary outcomes:
measure: Uptake of Genetic Counseling
timeFrame: Change from the baseline survey to four months after baseline
measure: Uptake of Genetic Testing
timeFrame: Change from the baseline survey to four months after baseline
Secondary outcomes:
measure: Knowledge about HBOC
timeFrame: Change from the baseline to two-week after baseline, and change from two-week follow up survey to four months after baseline
measure: Self-efficacy about attending genetic cancer risk assessment
timeFrame: Change from the baseline to two-week after baseline
measure: Beliefs and Attitudes about genetic cancer risk assessment
timeFrame: Change from the baseline to two-week after baseline
measure: Subjective norms about genetic cancer risk assessment
timeFrame: Change from the baseline to two-week after baseline
measure: Anticipatory emotions about genetic cancer risk assessment
timeFrame: Change from the baseline to two-week after baseline
measure: Acceptability of the intervention
timeFrame: At two weeks after baseline
measure: Feasibility of the intervention
timeFrame: At two weeks after baseline
Other outcomes:
measure: Feasibility of the Referral Screening Tool
timeFrame: Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
measure: Acceptability of the Referral Screening Tool
timeFrame: Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
measure: Adoption of the Referral Screening Tool
timeFrame: At the post implementation focus groups with community clinics adoption over the previous 48 months will be assessed
measure: Sustainability of the Referral Screening Tool
timeFrame: 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
Locations:
city: Washington
country: United States
facility: Georgetown Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Georgetown Lombardi Comprehensive Cancer Center
name: Alejandra Hurtado de Mendoza, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: