Clinical trial NCT06441474: Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women
Official title: Understanding and Addressing Rejection of Personalized Cancer Risk Information
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Female
Keywords: Risk rejection
Screening behaviour
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2024-06-04
Enrollment: 750
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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 screening 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 BCRAT model risk estimate and respond to that risk estimate. They will then complete a 12-month follow-up survey.

Eligibility criteria: Inclusion Criteria:

1. Female sex
2. Age 39-74 (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.

Primary outcomes:
measure: Risk rejection as measured by a numeric estimate.
timeFrame: At baseline survey
measure: Risk-concordant information seeking
timeFrame: At baseline survey
measure: Screening intentions
timeFrame: At baseline survey
Secondary outcomes:
measure: Goldilocks Risk Skepticism
timeFrame: At baseline survey
measure: Risk rejection as measured by a validated believability scale
timeFrame: At baseline survey
measure: Risk rejection as measured by risk relative to a typical woman their age.
timeFrame: At baseline survey
measure: Participant score on Subjective numeracy
timeFrame: At baseline survey
measure: Participant score on Risk Comprehension
timeFrame: At baseline survey
Other outcomes:
measure: Number of Participants who engage in additional breast cancer seeking behavior
timeFrame: At 12 month follow-up
measure: Participant score on Health literacy
timeFrame: At baseline survey
measure: Receipt of screening
timeFrame: At 12 month follow-up survey
measure: Racial demographic of participants
timeFrame: At baseline survey
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: University of Colorado, Denver
name: Laura Scherer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University at St. Louis
name: Erika Waters, PhD
role: PRINCIPAL_INVESTIGATOR
References: