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Current Projects

DiRECT: Disparities in Results of Immune Checkpoint Inhibitor Treatment Cohort Study (UG3CA260602)

Immune checkpoint inhibitors (ICIs) are a powerful and innovative mode of cancer therapy. However, little data has been collected about ICI treatment response among patients of African ancestry. Focusing on racial differences between people of African ancestry (AA) and European ancestry (EA) in ICI impact is important for three reasons. First, at the population level, AA patients are more likely than EA patients to have advanced cancers, an important disease group ICIs are intended to treat.  Second, due to racial differences in host immunity, AA individuals tend to have a stronger pro-inflammatory response than EAs. This could lead to a higher risk of immune-related adverse events (irAEs) while on ICIs.  Third, as a result of immune differences, AA patients who manage irAEs and continue ICI treatment may be more likely to benefit than EA patients.  However, AA populations may experience multiple barriers while accessing healthcare (e.g., discrimination, financial toxicity) that may lead to discontinuing ICIs. In order to address these knowledge gaps, we are conducting a cohort study with a focus on racial differences between AA patients and patients of EA in community oncology settings.

We will include all patients receiving anti-PD-1/-L1 therapy regardless of cancer site and enroll a total of 600 AA and 1,200 EA patients, with 1:2 match of AA to EA patients on cancer type within NCORP site.  Our specific aims are: 1. To examine racial differences and predictors of irAEs, comparing AA and EA patients on incidence and severity of irAEs and assessing disease, individual, and lifestyle factors as predictors of these differences. 2. To examine treatment delay and discontinuation between AA and EA patients and assess racial differences in irAEs, healthcare barriers, and other factors as potential causes of treatment interruptions.  3. To examine short- and long-term treatment outcomes, comparing AA and EA patients on objective response rate, recurrence, death, and health related quality of life after ICIs, and assessing treatment, disease, individual, and lifestyle factors as predictors of patient outcomes and potential causes of racial differences.

FOCUS-SGM: Adapting the FOCUS Program for Sexual and Gender Minority Cancer Patients and Caregivers

The goal of this project is to adapt the FOCUS (Family involvement, Outlook, Coping effectiveness, Symptom management) intervention and test its feasibility and acceptability among sexual and gender minority (SGM) cancer patients and their caregivers. SGM cancer patients and their caregivers face unaddressed challenges that adversely impact their quality of life, including the chronic stress engendered by living with a stigmatized SGM identity. The FOCUS intervention uses both psychoeducation and problem solving to improve quality of life, coping, and self-efficacy in cancer patients and their caregivers, and has been shown to be efficacious in three prior clinical trials. However, as noted by our SGM community partners, the LGBT Cancer Action Council (CAC), its content has not been tailored to SGM relationships.

Consequently, we propose to adapt the evidence-based FOCUS Program for SGM cancer patients and their caregivers (Aim 1). In collaboration with the LGBT CAC and guided by the transtheoretical SGM-affirmative adaptation model and ADAPT-ITT framework, we will conduct 6 focus groups with ≥24 SGM cancer patients and their ≥24 caregivers to “theater test” FOCUS and elicit qualitative feedback about adaptation. We will also elicit feedback from our panel of 5 topic experts in SGM research, and create a manualized, adapted intervention called FOCUS-SGM.  We will then assess the feasibility and acceptability and explore potential outcomes of the adapted FOCUS-SGM intervention in a two-arm pilot trial (Aim 2). We will randomize 80 SGM cancer patients and their caregivers (total N≥160) to either FOCUS-SGM or a waitlist control. Assessment of patients and caregivers will occur at baseline, post-intervention, and at a 3-month follow-up (~6 months after baseline). We will also explore whether potential outcome measures (quality of life, coping, self-efficacy to manage cancer, relationship communication, and minority stress) are responsive to the effect of FOCUS-SGM versus control.

ASCEND: A Multi-Institute Survivorship Study of Patients Living with Advanced and Metastatic Cancer Who Have Had Durable Response to Immune Checkpoint Inhibitors

Immune checkpoint inhibitors (ICIs) have markedly transformed the therapeutic landscape for many types of advanced malignancies over the past decade. A sizable proportion of patients with advanced cancer derive durable benefits from ICIs and achieve longer periods of progression-free survival or remission than previously possible. Yet we still know little about the determinants of durable response to ICI treatment and the symptom trajectory and survivorship needs of this growing patient population. Therefore, to help fill this gap we are conducting a study with two sister cohorts of patients living with advanced cancers.

First, a retrospective EHR data-only cohort which includes patients with advanced disease, inclusive of all cancer types, who have been treated with ICI based immunotherapy in 2014-2022. This large cohort will allow us to identify and study durable responders to ICIs, defined as patients who achieve partial or complete response to ICI treatment and live at least one year after ICI treatment initiation. The three aims of this first cohort are to 1a). Determine the proportion of patients who had durable response to ICI treatment (partial/complete response and alive ≥1 year since initial ICI treatment) and chart their survival trajectory; 1b) Identify clinical predictors for durable response to ICI treatment; 1c). In the independent DiRECT Cohort, validate the clinical predictors for durable response to ICI treatment.

Second, a prospective cohort will enroll and actively follow patients with durable response to ICI treatment for advanced lung cancer, kidney cancer, and melanoma, the three most common cancers treated with ICIs. Clinical and patient-reported outcome data will be collected at baseline and every 6 months during follow up. This prospective cohort will allow us to study long-term survival and physical and psychosocial symptom trajectories in patients with durable response to ICIs, and to identify clinical and modifiable behavioral factors predictive of long-term survival and common side effects of ICI treatment. The predictors identified in these analyses will be independently validated in the DiRECT Cohort, a large ongoing study of racial disparities in ICI treatment led by the study team. Our specific aims of the second cohort are: 2a) Identify long-term survival and longitudinal trajectories of patients’ physical and psychosocial symptoms after ICI treatment; 2b) Investigate the relationships of long-term survival and common side effects from ICI treatment with multidimensional predictors; 2c). In the independent DiRECT Cohort, validate the predictors for survival and common side effects in patients with durable response. Findings from our study will provide much-needed data that can inform new evidence-based intervention strategies as the next step to optimize survivorship care and extend and improve quality of life for the growing population of survivors living after a diagnosis of advanced cancer due to ICI treatment.

SOGI: Sexual Orientation and Gender Identity Data Collection in Community Oncology Practice

Sexual and gender minority people (SGM; e.g., lesbian, gay, bisexual, transgender, intersex, etc.) have received limited cancer research attention, in part because large-scale research efforts are hampered by lack of consistent collection of SOGI data in oncology practices. In a survey of 271 NCI Community Oncology Research Program (NCORP) practices in 2022, we found that less than half of practices (42%) were consistently collecting SOGI data. Oncology practices may not collect SOGI data due to organizational- and provider-level barriers, even though SGM cancer patients often want to disclose SOGI, disclosure of SOGI is correlated with better outcomes among SGM patients, and multiple national organizations recommend that oncology practices collect SOGI data as part of efforts to reduce SGM disparities.

In this study, we will use the Consolidated Framework for Implementation Research (CFIR) to assess implementation factors such as the geopolitical context of laws where NCORP practices are located that influence SOGI data collection (“Outer Setting”), the characteristics and contexts of the practices and providers (“Inner Setting” and “Individuals”), and strategies for implementing SOGI data within each practice’s clinical flow (“Innovation" and “Processes”). Building on strong preliminary data, we will purposively sample 16 NCORP practices diverse in geography, practice setting, and current SOGI data collection. We will complete 3 in-depth interviews at each practice, one each with a direct care provider (e.g., oncologist, nurse, advanced practice provider), an administrator, and a person responsible for intake data (e.g., front desk staff, IT specialist). Our specific aims are: 1) To assess which implementation factors are difference-makers in the collection and use of SOGI data in community oncology using qualitative thematic analysis and Boolean-logic-based configurational analysis, 2) To explore how SOGI data are collected in community oncology practices, with the goal of collating practice-driven recommendations for data collection, and 3) To explore how SOGI data are used in community oncology practices, with the goal of informing a future intervention to improve cancer care for SGM patients.

The Science of Cancer Health Equity for Sexual and Gender Minority Communities Conference

Sexual and gender minority people (SGM) experience multiple cancer-related disparities, including higher rates of cancer risk factors, lower rates of cancer screening, higher lifetime risk of cancer, and unmet needs during cancer survivorship. Although many national organizations, including the National Cancer Institute (NCI) and the American Cancer Society (ACS), have stated the need for more cancer research among SGM communities, there is currently no consensus about the highest research priorities, promising research models, or mechanisms for collaboration between geographically dispersed scientific teams.

In Fall 2023 the first “The Science of Cancer Health Equity for Sexual and Gender Minority Communities Conference” was held. The aim of the conference is to bring together researchers, trainees, early-stage investigators, and community stakeholders to review the current science on cancer health equity for SGM persons, identify high-priority research topics, and develop novel approaches to engage communities and influence policy. It is structured around a transdisciplinary framework: looking within, across, and between areas of scientific expertise and community wisdom to establish priorities. To learn more about the goals of the conference and details about this year’s conference, please visit .