Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations

Mittendorf, Kathleen F.; Kauffman, Tia L.; Amendola, Laura M.; Anderson, Katherine; Biesecker, Barbara B.; Dorschner, Michael O.; Duenas, Devan M.; Eubanks, Donna; Feigelson, Heather Spencer; Gilmore, Marian J.; Hunter, Jessica Ezzell; Joseph, Galen; Kraft, Stephanie A.; Lee, Sandra Soo‐Jin; Leo, Michael C.; Liles, Elizabeth; Lindberg, Nangel M.; Muessig, Kristin R.; Okuyama, Sonia; Porter, Kevin; Riddle, Leslie; Rolf, Bradley A; Rope, Alan F.; Zepp, Jamilyn; Jarvik, Gail P.; Wilfond, Benjamin S.; Goddard, Katrina A.B.

doi:10.1016/j.cct.2021.106432

Cited by 22 publications

(39 citation statements)

References 68 publications

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“…The CHARM study is part of the Clinical Sequencing Evidence-Generating Research (CSER) Consortium [ 33 ]. The CHARM setting and study design have been previously described elsewhere [ 31 ]. Participants ages 18–49 were recruited from Kaiser Permanente Northwest (KPNW) in the Portland, Oregon metropolitan area, and Denver Health (DH), in Denver County, Colorado.…”

Section: Methodsmentioning

confidence: 99%

“…Participants ages 18–49 were recruited from Kaiser Permanente Northwest (KPNW) in the Portland, Oregon metropolitan area, and Denver Health (DH), in Denver County, Colorado. Recruitment efforts were enriched for medically underserved populations at both sites based on previously defined methods [ 31 ]. The study defined enrolled participants with one or more of the following barriers to healthcare access as belonging to medically underserved populations: (1) Hispanic ethnicity or a race other than White; (2) residing in a Health Resources and Services Administration–defined medically underserved census tract; (3) Spanish language preference for the risk assessment or any subsequent study survey; (4) educational attainment less than high school graduate; (5) income < 200% of the Federal Poverty Level; (6) use of Medicaid insurance or being uninsured; (7) sexual orientation other than heterosexual; (8) gender identity other than cisgender female/male [ 34 ].…”

Section: Methodsmentioning

confidence: 99%

“…Following initial recruitment, patients were asked to complete the family history assessment tool, which has been previously described [ 31 , 32 ]. This patient-facing web tool was designed using a mobile-first approach and literacy-adapted from clinician-facing versions of two guideline-recommended validated hereditary cancer risk assessments: the B-RST™ 3.0 for HBOC risk [ 11 , 35 ], and PREMM® 5 for Lynch syndrome (LS) risk [ 8 , 36 – 38 ].…”

Section: Methodsmentioning

confidence: 99%

“…The Cancer Health Assessments Reaching Many (CHARM) study designed a multimodal intervention to address care disparities in hereditary cancer services [ 31 ] and tested the intervention in a population enriched for individuals from medically underserved populations. As one intervention component, we designed a literacy-adapted, electronic, patient-facing family history self-assessment and automated risk assessment application [ 32 ].…”

Section: Introductionmentioning

confidence: 99%

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Literacy-adapted, electronic family history assessment for genetics referral in primary care: patient user insights from qualitative interviews

Mittendorf

Lewis

Duenas

et al. 2022

Hered Cancer Clin Pract

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Background Risk assessment for hereditary cancer syndromes is recommended in primary care, but family history is rarely collected in enough detail to facilitate risk assessment and referral – a roadblock that disproportionately impacts individuals with healthcare access barriers. We sought to qualitatively assess a literacy-adapted, electronic patient-facing family history tool developed for use in diverse, underserved patient populations recruited in the Cancer Health Assessments Reaching Many (CHARM) Study. Methods Interview participants were recruited from a subpopulation of CHARM participants who experienced barriers to tool use in terms of spending a longer time to complete the tool, having incomplete attempts, and/or providing inaccurate family history in comparison to a genetic counselor-collected standard. We conducted semi-structured interviews with participants about barriers and facilitators to tool use and overall tool acceptability; interviews were recorded and professionally transcribed. Transcripts were coded based on a codebook developed using inductive techniques, and coded excerpts were reviewed to identify overarching themes related to barriers and facilitators to family history self-assessment and acceptability of the study tool. Results Interviewees endorsed the tool as easy to navigate and understand. However, they described barriers related to family history information, literacy and language, and certain tool functions. Participants offered concrete, easy-to-implement solutions to each barrier. Despite experience barriers to use of the tool, most participants indicated that electronic family history self-assessment was acceptable or preferable in comparison to clinician-collected family history. Conclusions Even for participants who experienced barriers to tool use, family history self-assessment was considered an acceptable alternative to clinician-collected family history. Barriers experienced could be overcome with minor adaptations to the current family history tool. Trial registration This study is a sub-study of the Cancer Health Assessments Reaching Many (CHARM) trial, ClinicalTrials.gov, NCT03426878. Registered 8 February 2018.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Literacy-adapted, electronic family history assessment for genetics referral in primary care: patient user insights from qualitative interviews

Mittendorf

Lewis

Duenas

et al. 2022

Hered Cancer Clin Pract

Self Cite

View full text Add to dashboard Cite

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“…Study procedures involved participants submitting a saliva kit, receiving results by phone or letter from a study genetic counselor, having their health record reviewed, completing surveys, and, for a subset of participants, being invited to complete 1 or more qualitative interviews. For more information about the CHARM study design see Mittendorf et al 14 Figure 1 shows the study flow including when individuals were surveyed and interviewed.…”

Section: Settingmentioning

confidence: 99%

Motivations and concerns of patients considering participation in an implementation study of a hereditary cancer risk assessment program in diverse primary care settings

Duenas

Shipman

Porter

et al. 2022

Genetics in Medicine

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Understanding the motivations and concerns of patients from diverse populations regarding participation in implementation research provides the needed evidence about how to design and conduct studies for facilitating access to genetics services. Within a hereditary cancer screening study assessing a multifaceted intervention, we examined primary care patients' motivations and concerns about participation. Methods: We surveyed and interviewed study participants after they enrolled, surveyed those who did not complete enrollment, and used descriptive qualitative and quantitative methods to identify motivations and concerns regarding participation. Results: Survey respondents' most common motivations included a desire to learn about their future risk (81%), receiving information that may help family (58%), and a desire to advance research (34%). Interviews revealed 3 additional important factors: affordability of testing, convenience of participation, and clinical relationships supporting research decision-making. Survey data of those who declined enrollment showed that the reasons for declining included concerns about privacy (38%), burdens of the research (19%), and their fear of not being able to cope with the genetic information (19%). Conclusion: Understanding the facilitating factors and concerns that contribute to decisions about research may reveal ways to improve equity in access to care and research that could lead to greater uptake of genomic medicine across diverse primary care patient populations.

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Conducting clinical genomics research during the COVID‐19 pandemic: Lessons learned from the CSER consortium experience

Kraft

Russell

Bensen

et al. 2022

American J of Med Genetics Pt A

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Clinical research studies have navigated many changes throughout the COVID-19 pandemic. We sought to describe the pandemic 0 s impact on research operations in the context of a clinical genomics research consortium that aimed to enroll a majority of participants from underrepresented populations. We interviewed (July to November 2020) and surveyed (May to August 2021) representatives of six projects in the Clinical Sequencing Evidence-Generating Research (CSER) consortium, which studies the implementation of genome sequencing in the clinical care of patients from populations that are underrepresented in genomics research or are medically underserved. Questions focused on COVID 0 s impact on participant recruitment, enrollment, and engagement, and the transition to teleresearch. Responses were combined and thematically analyzed. Projects described factors at the project, institutional, and community levels that affected their experiences. Project factors included the project 0 s progress at the pandemic 0 s onset, the urgency of in-person clinical care for the disease being studied, and the degree to which teleresearch procedures were already incorporated. Institutional and community factors included institutional

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Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations

Cited by 22 publications

References 68 publications

Literacy-adapted, electronic family history assessment for genetics referral in primary care: patient user insights from qualitative interviews

Literacy-adapted, electronic family history assessment for genetics referral in primary care: patient user insights from qualitative interviews

Motivations and concerns of patients considering participation in an implementation study of a hereditary cancer risk assessment program in diverse primary care settings

Conducting clinical genomics research during the COVID‐19 pandemic: Lessons learned from the CSER consortium experience

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