Kuang Yi-Wen

An eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Patients With Metastatic Cancers: Protocol for a Randomized Trial

Background Germline BRCA1 and BRCA2 testing is a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With Food and Drug Administration approval for poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors in patients with metastatic breast, ovarian, pancreatic, and prostate cancer, there is an additional therapeutic rationale for testing all patients with these cancers for germline BRCA1 and BRCA2 mutations. However, many at-risk patients do not have access to genetic services, leaving many genetic carriers unidentified. Objective The eREACH (A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate, and Pancreatic Cancer Patients) study evaluates the effectiveness of a theoretically and stakeholder-informed eHealth (eg, digital) delivery alternative to traditional genetic counseling for patients with metastatic breast or prostate cancer or advanced or metastatic ovarian or pancreatic cancer referred for genetic testing to determine whether they are candidates for a PARP inhibitor. Methods The eREACH study is a randomized noninferiority study using a 2 × 2 design to test a self-directed digital intervention to deliver clinical genetic testing for patients with metastatic cancers. The traditional standard-of-care pretest (visit 1) and posttest (visit 2—disclosure) counseling delivered by a genetic counselor is replaced with our patient-informed digital intervention. The four arms were as follows: arm A, genetic counselor for visits 1 and 2; arm B, genetic counselor for visit 1 and digital intervention for visit 2; arm C, digital intervention for visit 1 and genetic counselor for visit 2; and arm D, digital intervention for both visits. Participants were adults with advanced or metastatic breast, ovarian, pancreatic, and prostate cancer. The primary outcomes of this study were change in genetic knowledge and anxiety from baseline to postdisclosure assessment. We will test whether the digital intervention is noninferior to standard-of-care counseling with a genetic counselor using a modified noninferiority ANOVA of the posttest disclosure minus baseline change scores. In secondary analyses, we will test pairwise differences among the 4 groups. Results As of January 2025, we have completed enrollment of 229 participants. Data analysis is ongoing, and we expect the results to be published in 2025. Conclusions Increasing indications for BRCA1 and BRCA2 testing create a pressing need to evaluate alternative delivery models to increase access and uptake of these tests while maintaining adequate patient cognitive, affective, and behavioral outcomes. The eREACH study evaluates the effectiveness of an interactive, patient-centered digital intervention to deliver clinical genetic testing to patients with metastatic cancers. We expect that this work will inform evidence-based guidelines and the standard of care for delivery of genetic testing, and it is designed to be broadly applicable and easily adaptable for other populations and settings even beyond oncology. Trial Registration ClinicalTrials.gov NCT04353973; https://clinicaltrials.gov/study/NCT04353973 International Registered Report Identifier (IRRID) DERR1-10.2196/72515

Chatbot-interfaced and cognitive-affective barrier-driven messages to improve colposcopy adherence after abnormal Pap test results in underserved urban women: A feasibility pilot study

Abstract Challenges in ensuring adherence to colposcopy and follow-up recommendations, particularly within underserved communities, hinder the delivery of appropriate care. Informed by our established evidence-based program, we sought to assess the feasibility and acceptability of a novel cognitive-affective intervention delivered through a Chatbot interface, aimed to enhance colposcopy adherence within an urban inner-city population. We developed the evidence-based intervention, CervixChat, to address comprehension of colposcopy’s purpose, human papillomavirus (HPV) understanding, cancer-related fatalistic beliefs, procedural concerns, and disease progression, offered in both English and Spanish. Females aged 21–65, with colposcopy appointments at an urban OBGYN clinic, were invited to participate. Enrolled patients experienced real-time counseling messages tailored via a Chatbot-driven barriers assessment, dispatched via text one week before their scheduled colposcopy. Cognitive-affective measures were assessed at baseline and through a 1-month follow-up. Participants also engaged in a brief post-intervention satisfaction survey and interview to capture their acceptance and feedback on the intervention. The primary endpoints encompassed study adherence (CervixChat response rate and follow-up survey rate) and self-evaluated intervention acceptability, with predefined feasibility benchmarks of at least 70% adherence and 80% satisfaction. Among 48 eligible women scheduled for colposcopies, 27 (56.3%) agreed, consented, and completed baseline assessments. Participants had an average age of 34 years, with 14 (52%) identifying as non-Hispanic White. Of these, 21 (77.8%) engaged with the CervixChat intervention via mobile phones. Impressively, 26 participants (96.3%) attended their diagnostic colposcopy within the specified timeframe. Moreover, 22 (81.5%) completed the follow-up survey and a brief interview. Barriers assessment revealed notable encodings in the Affect and Values/Goals domains, highlighting concerns and understanding around HPV, as well as its impact on body image and sexual matters. Persistent and relatively high intrusive thoughts and lowered risk perceptions regarding cervical cancer were reported over time, unaffected by the intervention. Post-intervention evaluations documented high satisfaction and perceived usefulness, with recommendations for incorporating additional practical and educational content. Our findings underscore the robust satisfaction and practicality of the CervixChat intervention among a diverse underserved population. Moving forward, our next step involves evaluating the intervention’s efficacy through a Sequential Multiple Assignment Randomized Trial (SMART) design. Enhanced by personalized health coaching, we aim to further bolster women’s risk perception, address intrusive thoughts, and streamline resources to effectively improve colposcopy screening attendance.

A Proposed mHealth Intervention to Address Patient Barriers to Colposcopy Attendance: Qualitative Interview Study of Clinic Staff and Patient Perspectives

Background Cervical cancer disparities persist among minoritized women due to infrequent screening and poor follow-up. Structural and psychosocial barriers to following up with colposcopy are problematic for minoritized women. Evidence-based interventions using patient navigation and tailored telephone counseling, including the Tailored Communication for Cervical Cancer Risk (TC3), have modestly improved colposcopy attendance. However, the efficacious TC3 intervention is human resource-intense and could have greater reach if adapted for mobile health, which increases convenience and access to health information. Objective This study aimed to describe feedback from clinic staff members involved in colposcopy processes and patients referred for colposcopy regarding adaptions to the TC3 phone-based intervention to text messaging, which addresses barriers among those referred for colposcopy after abnormal screening results. Methods Semistructured depth qualitative interviews were conducted over Zoom [Zoom Communications, Inc] or telephone with a purposive sample of 22 clinic staff members (including clinicians and support staff members) and 34 patients referred for colposcopy from 3 academic obstetrics and gynecology (OB-GYN) clinics that serve predominantly low-income, minoritized patients in different urban locations in New Jersey and Pennsylvania. Participants were asked about colposcopy attendance barriers and perspectives on a proposed text message intervention to provide tailored education and support in the time between abnormal cervical screening and colposcopy. The analytic team discussed interviews, wrote summaries, and consensus-coded transcripts, analyzing output for emergent findings and crystallizing themes. Results Clinic staff members and patients had mixed feelings about a text-only intervention. They overwhelmingly perceived a need to provide patients with appointment reminders and information about abnormal cervical screening results and colposcopy purpose and procedure. Both groups also thought messages emphasizing that human papillomavirus is common and cervical cancer can be prevented with follow-up could enhance attendance. However, some had concerns about the privacy of text messages and text fatigue. Both groups thought that talking to clinic staff members was needed in certain instances; they proposed connecting patients experiencing complex psychosocial or structural barriers to staff members for additional information, psychological support, and help with scheduling around work and finding childcare and transportation solutions. They also identified inadequate scheduling and reminder systems as barriers. From this feedback, we revised our text message content and intervention design, adding a health coaching component to support patients with complex barriers and concerns. Conclusions Clinic staff members and patient perspectives are critical for designing appropriate and relevant interventions. These groups conveyed that text message-only interventions may be useful for patients with lesser barriers who may benefit from reminders, basic educational information, and scheduling support. However, multimodal interventions may be necessary for patients with complex barriers to colposcopy attendance, which we intend to evaluate in a subsequent trial.