Study Design
A prospective, pre-post survey study design was used to evaluate baseline and immediate post-intervention intentions, knowledge, and beliefs regarding genetic counseling, as well as to assess satisfaction with the video intervention. The study was registered at Clinicaltrials.gov (NCT04082117) and was approved by the Institutional Review Board at the University of Illinois at Chicago (#2016-1219). All study participants provided written informed consent.
Study Population
The study was conducted in a mammography center at a safety net academic medical center in Chicago, IL, between August, 2019 and October, 2019. Eligibility criteria included: 1) AA women between the ages of 25 to 69 years old presenting for a screening or diagnostic mammogram; 2) no personal history of breast cancer; 3) never attended an appointment with a genetic counselor; 4) underwent breast cancer risk assessment at the time of the mammogram; and 4) were recommended for genetic counseling based on family history of breast and/or ovarian cancer. Formal power calculations are difficult to perform for pilot studies. A sample size of n=30 is commonly recommended for pilot studies.37 We followed that practice and enrolled 30 participants.
Breast Cancer Risk Assessment
The participating mammography center conducted family history screening for hereditary cancer risk as a routine component of the evaluation for all women undergoing screening or diagnostic breast imaging beginning in 2018. Risk assessment was conducted at the time women checked-in for the mammogram using a software application (CancerIQ®) on tablet computers and patient-reported information on family cancer history. Women who met national guideline criteria for genetic counseling referral(37) due to hereditary breast cancer risk were advised by mammography center staff to obtain a referral from their primary care physician (PCP) to the Hereditary Cancer Clinic at our institution. PCPs were notified of the recommendation for genetic counseling referral. Participants for this study were recruited from the group of women who received a recommendation for genetic counseling as a result of the risk assessment performed at the time of their mammogram.
Study Recruitment and Participation
Radiology technicians gave a study recruitment flyer to all women who were recommended for genetic counseling and briefly described the study to eligible women using a recruitment script. Women who expressed interest in participating in the study were directed to a privacy-protected area in the mammography center where research personnel completed eligibility screening and informed consent. Research personnel then administered a pre-viewing survey, played the six-minute narrative decision aid on a laptop computer for the participant to view, and then administered a post-viewing survey. Women completing all study activities received a stipend for research participation.
Data Collection
The pre-viewing survey and post-viewing survey were administered by research personnel using an electronic data capture and management system (REDCap) with an encrypted laptop computer. The initial study protocol included review of the electronic health record 6 months after completion of study recruitment to determine rates of attendance at a genetic counseling session. However, due to clinic restrictions that were initiated in 2020 due to the COVID-19 pandemic, all elective outpatient appointments were cancelled, so the 6-month medical record review was not completed.
Culturally Sensitive Decision Aid to Promote Genetic Counseling
A culturally sensitive, narrative decision aid was developed by the study team to promote uptake of genetic counseling among AA women at risk for a hereditary breast cancer syndrome.36 Development of the intervention was guided by the IMBP theoretical framework, which asserts that the primary driver of engaging in a health behavior is forming an intention to do so. The process of forming an intention is determined by three cognitive domains (expected outcomes of engaging in the behavior, cultural norms, and self-efficacy beliefs). The IMBP further proposes that the relationship between intention to engage in a health behavior and carrying through on the intention may be impacted by contextual factors.(38) In order to ensure that the intervention is culturally sensitive for AA women, we employed Kreuter’s framework for achieving cultural appropriateness in health promotion programs.(39) Details about intervention design methodology were previously published.(36) Briefly, phase 1 consisted of in-depth, semi-structured interviews and story circles with AA women recommended for genetic counseling by their PCP based on their family history of breast/ovarian cancer.(28, 36) Importantly, the majority of study participants did not attend a genetic counseling session even though it was recommended by their PCP. One-on-one interviews garnered information about motivating and facilitating factors and barriers to genetic counseling attendance. Story circles sought to understand women’s personal and familial experiences related to breast cancer. A script was developed for the narrative intervention based on themes that emerged from in-depth interviews and story circles. Phase 2 consisted of a series of focus groups conducted with three cohorts: an independent group of AA women with a family history of breast cancer who had not undergone genetic counseling and did not participate in one-on-one interviews, primary care providers at a federally qualified health center, and representatives from breast cancer advocacy organizations. Focus groups provided feedback on the script and the final video production. The decision aid that was produced is a six-minute narrative video that tells the story of an AA women recommended for genetic counseling due to the presence of breast cancer in her family. A link to the narrative intervention is provided at the end of this manuscript.
Survey Instrument
Pre- and post- survey questions, guided by the IMBP theoretical constructs, assessed participants’ intentions, knowledge, perceived normative beliefs, barriers, self-efficacy beliefs, attitudes, and environmental constraints. Intentions regarding GC attendance were measured with six items. Responses for four of these items were measured on a 5-point likert scale ranging from 1 (extremely likely) to 5 (extremely unlikely), and 1 item was open-ended. Knowledge about genetic counseling was measured by 6 true/false items.(40) Perceived normative beliefs were measured with two yes/no items.(41) Barriers to GC were captured by three items (yes/no). Self-efficacy beliefs were also measured with 3 items with responses captured by a 5-point likert scale ranging from 1 (strongly agree) to 5 (strongly disagree).(42, 43) Attitudes about the importance of GC were measured with 1-item using a 10-point likert scale ranging from 0 (not at all important) to 10 (very important). Environmental constraints were only measured at pre-test since the intervention was not designed to impact these factors, and were measured with 6 true/false items. Nine questions assessed satisfaction with the video, with responses captures as a 5-point Likert scale ranging from 1 (either strongly agree or extremely likely to 5 (strongly disagree or extremely or unlikely)(44) or as yes/no response for three questions, and one open-ended response.
Statistical Analysis
Demographic characteristics of participants were summarized with descriptive statistics. Survey responses were summarized as frequencies and percentages. Responses of “no” and “not sure” were combined into the same response group. Pre- and post-intervention responses were compared using McNemar’s test for paired data. Fisher’s exact text was used in instances where the number of responses were less than five. A two-sided p-value less than 0.05 was considered statistically significant.