Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hereditary Breast and Ovarian Cancer Syndrome

Syndrome

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." Participants in the video arm will be asked to watch an 18-minute video that the research team developed and tested previously about HBOC and genetic services. The video is recorded with Spanish audio and is available with English subtitles.

Participants in the Fact Sheet arm will receive a Fact sheet about HBOC and genetic services and will be asked to read it in their own time. The Fact Sheet is available in English and Spanish.

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.

Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."

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.

FORCE Fact Sheet

Alejandra Hurtado de Mendoza, Ph.D

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.

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.

Hybrid Type 1 research design (efficacy study). Two arm randomized controlled trial and Implementation Focused Process Evaluation

Only self-identified women will be recruited for this study

CONTIGO - Informing Latinas About HBOC Risk

CONTIGO - Informing Latinas About HBOC Risk: a Randomized Controlled Trial

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?)

Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.

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.

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.

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.

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)

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).

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)

Scale items on a 7-point Likert-type response (from 1-strongly disagree to 7-strongly agree).

Overall acceptability is measured on a 4-item self-reported scale ranging from 1 to 10, where 1 = not at all to 10 = highly

Proportion of women who have watched/read the video or fact sheet at the two week follow up

National Cancer Institute (NCI)

Virginia Commonwealth University

Georgetown University

Culturally targeted narrative video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." With R03 funding (R03CA191543) we developed a culturally targeted narrative video for at-risk Latinas. A multidisciplinary team of researchers collaborated with filmmakers to develop the script and video. The script was informed by health behavior conceptual models, evidence-based risk communication strategies, and formative research (40 interviews with providers and at-risk Latinas). The script addressed identified knowledge gaps (e.g., incorrect belief that pap smears screen for ovarian cancer), facilitators (e.g., inform family cancer risk), barriers (e.g., emotional concerns), and cultural factors (e.g., respect). The 18-minute video illustrates the GCRA process with the story of Rosa, a Latina cancer survivor at increased risk of HBOC. Rosa learns about HBOC risk factors, overcomes barriers, and attends genetic counseling.

Culturally-Targeted Video

A publically available Spanish-language fact sheet about HBOC and GCRA developed by FORCE.

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).

The investigators will conduct a two-arm RCT to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. FORCE fact sheet on enhancing genetic cancer risk assessment (GCRA; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among Latinas at increased risk for hereditary breast and ovarian cancer (HBOC).

All participants will receive referrals to free telephone genetic counseling in Spanish to address cost, pragmatic, and language barriers. The investigators will recruit 28 Latina women at-risk of HBOC (14 randomized at each arm) at three sites with sizable Latinx populations. The sites include community clinics/health organizations and hospitals with whom we have established collaborations \[Georgetown University (DC); Virginia Commonwealth University (VA)\].

Results will improve efforts to translate genomic guidelines into practice and will reduce disparities by evaluating a low cost highly disseminable culturally-targeted video while gathering data on effectiveness and implementation.

Aim 1. Evaluate the impact of video vs. FORCE fact sheet on GCRA and testing uptake and psychosocial outcomes.

Aim 2. Assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and FORCE fact sheet) and of the HBOC screening process at the community clinics.

28 Latina women at risk for HBOC will be randomly assigned to one arm after completing the baseline assessment.

We will conduct a Hybrid Type 1 design to (1) test the effectiveness of two intervention approaches (video vs. FORCE fact sheet) in enhancing GCRA uptake and psychosocial outcomes and to (2) collect data on implementation outcomes regarding the interventions (video vs. FORCE fact sheet) and the implementation of a short screening survey to identify at-risk women.

Given the hybrid design, we will also conduct focus groups with clinic staff, in which we estimate 32 staff to participate. Given their participation in the focus groups, clinic staff are also considered participants, but they are not part of the randomized trial.

Enhance the Use of Genetic Counseling and Testing in Latinas

A Randomized Controlled Trial to Enhance the Use of Genetic Counseling and Testing in Latinas

Change in knowledge about HBOC and GCRA. Knowledge will be measured using a 13-item Erblich et al., 2005 scale about genetic knowledge about breast cancer. 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 0-13.

Change in intentions to participate in genetic counseling and genetic testing. A 2-item scale developed by Sussner, Jandorf, Thompson, and Valdimarsdottir, 2010 will be used to assess intentions to participate in genetic counseling and testing. Participants respond to a Likert-trype scale from 1 (Not at all) to 5 (Very) how likely it is that they will participate in genetic counseling and testing in the next three months.

Changes in beliefs and attitudes about genetic counseling and genetic testing. The outcome will be assessed by a 30-item scale developed by Sussner, Jandorf, Thompson et al., 2012 in which participants respond to a Likert-type scale from 1 (completely disagree) to 7 (complete agree).

Changes in anticipatory emotions about receive genetic counseling. Assessed by participants' responses to how they feel 'right now' about the specific behavior of receiving genetic counseling and testing in the next three months. Responses are in a 7-point Likert-type form (from 1-strongly disagree to 7-strongly agree).

Proportion of participants that receive genetic counseling. The outcome will be assessed by self-report (e.g., Have you received genetic counseling in the past three months?) and confirmed with the genetic counseling company records.

Proportion of participants that receive genetic testing. The outcome will be assessed by self-report (e.g., Have you received genetic testing in the past three months?) and confirmed with the genetic counseling company records.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CONTIGO - Informing Latinas About HBOC Risk	NCT05130606	Hereditary Brea...	Culturally Targ... FORCE Fact Shee...	18 Years -	Georgetown University
Enhance the Use of Genetic Counseling and Testing in Latinas	NCT04544501	Hereditary Brea...	Culturally-Targ... FORCE Fact Shee...	18 Years -	Georgetown University
CONTIGO - Informing Latinas About HBOC Risk	NCT05130606	Hereditary Brea...	Culturally Targ... FORCE Fact Shee...	18 Years -	Georgetown University
Enhance the Use of Genetic Counseling and Testing in Latinas	NCT04544501	Hereditary Brea...	Culturally-Targ... FORCE Fact Shee...	18 Years -	Georgetown University

Spots Global Cancer Trial Database for force fact sheet