Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women

Breast Cancer Female Clinical Trial

Official title:

Understanding and Addressing Rejection of Personalized Cancer Risk Information

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441474
• Other study ID #: 23-0345.cc
• Secondary ID: 1R01CA279953-01
• Status: Not yet recruiting
• Start date: December 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: University of Colorado, Denver
• Contact: Damilola Jolaoso, MSc
• Phone: 303-724-2504
• Email: Damilola.Jolaoso[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal observational study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

Description:

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by 1) identifying demographic and psychological factors associated with risk rejection and 2) identify how risk rejection influences risk-concordant mammography seeking behavior. The study will test a priori theory-derived hypotheses about the precursors of risk rejection and the influence of rejection on real-life screening decision making.

The Breast Cancer Risk Assessment Tool (BCRAT) will be used to asses participant's breast cancer risk. This model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity Participants will be required to complete the baseline survey in which they receive their Gail model risk estimate and respond to that risk estimate. They will then complete a 12-month follow-up survey.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 39 Years to 49 Years

Eligibility

Inclusion Criteria:

1. Female sex

2. Age 39-49 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)

3. English literacy

Exclusion Criteria:

1. Prior diagnosis of

1. breast cancer

2. Ductal carcinoma in situ (DCIS)

3. Lobular carcinoma in situ (LCIS)

4. Known BRCA1/2 gene mutation

5. Cowan syndrome

6. Li-Fraumeni syndrome

7. Having received previous chest radiation for treatment of Hodgkin's lymphoma.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants who engage in additional breast cancer seeking behavior	Whether women talked to a health provider about their breast cancer risk and/or received additional breast health services.	After 12 month follow-up
Primary	Number of Participants who reject their risk information.	Test the Theory of Motivated Reasoning, Bayesian Updating, Trust, and Personal relevance to why participants rejected their personal risk information.	After baseline survey, an average of 1 week
Primary	Number of Participants who engage in Risk-concordant information seeking, screening intentions, and receipt of screening.	Interaction of participant's estimated risk and risk rejection on information seeking behavior, screening intention, and screening behavior up to 1 year after the initial survey.	After 12 month follow-up
Secondary	Participant score on Objective numeracy	Lower educational attainment and lower numeracy are associated with poorer understanding of health information. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection	After baseline survey, an average of 1 week
Secondary	Participant score on Subjective numeracy	Lower educational attainment and lower numeracy are associated with poorer understanding of health information. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection	After baseline survey, an average of 1 week
Secondary	Participant score on Health literacy	Lower health literacy is associated with poorer understanding of health information. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection	After baseline survey, an average of 1 week
Secondary	Racial demographic of participants	Race is associated with education, numeracy and health literacy. We will verify that these socio-demographic variables are associated with risk comprehension and explore whether they are also associated with risk rejection	After baseline survey, an average of 1 week