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CONTIGO - Informing Latinas About HBOC Risk

Primary Purpose

Hereditary Breast and Ovarian Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."
FORCE Fact Sheet
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hereditary Breast and Ovarian Cancer focused on measuring Breast cancer, Ovarian cancer, Hereditary cancer, Latinas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Georgetown Lombardi Comprehensive Cancer Center
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video Arm

Fact Sheet Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Uptake of Genetic Counseling
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.
Uptake of Genetic Testing
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.

Secondary Outcome Measures

Knowledge about HBOC
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.
Self-efficacy about attending genetic cancer risk assessment
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)
Beliefs and Attitudes about genetic cancer risk assessment
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).
Subjective norms about genetic cancer risk assessment
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)
Anticipatory emotions about genetic cancer risk assessment
Scale items on a 7-point Likert-type response (from 1-strongly disagree to 7-strongly agree).
Acceptability of the intervention
Overall acceptability is measured on a 4-item self-reported scale ranging from 1 to 10, where 1 = not at all to 10 = highly
Feasibility of the intervention
Proportion of women who have watched/read the video or fact sheet at the two week follow up

Full Information

First Posted
September 7, 2021
Last Updated
August 9, 2023
Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI), Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05130606
Brief Title
CONTIGO - Informing Latinas About HBOC Risk
Official Title
CONTIGO - Informing Latinas About HBOC Risk: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI), Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Breast and Ovarian Cancer
Keywords
Breast cancer, Ovarian cancer, Hereditary cancer, Latinas

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hybrid Type 1 research design (efficacy study). Two arm randomized controlled trial and Implementation Focused Process Evaluation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Fact Sheet Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FORCE Fact Sheet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Uptake of Genetic Counseling
Description
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
Title
Uptake of Genetic Testing
Description
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 survey to four months after baseline
Secondary Outcome Measure Information:
Title
Knowledge about HBOC
Description
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, and change from two-week follow up survey to four months after baseline
Title
Self-efficacy about attending genetic cancer risk assessment
Description
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
Title
Beliefs and Attitudes about genetic cancer risk assessment
Description
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
Title
Subjective norms about genetic cancer risk assessment
Description
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
Title
Anticipatory emotions about genetic cancer risk assessment
Description
Scale items on a 7-point Likert-type response (from 1-strongly disagree to 7-strongly agree).
Time Frame
Change from the baseline to two-week after baseline
Title
Acceptability of the intervention
Description
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
Title
Feasibility of the intervention
Description
Proportion of women who have watched/read the video or fact sheet at the two week follow up
Time Frame
At two weeks after baseline
Other Pre-specified Outcome Measures:
Title
Feasibility of the Referral Screening Tool
Description
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)
Title
Acceptability of the Referral Screening Tool
Description
Qualitative measure captured through semi-structured interviews using the Consolidated Framework for Implementation Research.
Time Frame
Change from the pre-implementation focus groups with community clinics to post implementation focus groups with community clinics (48 months)
Title
Adoption of the Referral Screening Tool
Description
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
Title
Sustainability of the Referral Screening Tool
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only self-identified women will be recruited for this study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandra Hurtado de Mendoza, Ph.D
Organizational Affiliation
Georgetown Lombardi Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CONTIGO - Informing Latinas About HBOC Risk

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