Using ethnographic approaches to document, evaluate, and facilitate virtual community-engaged implementation research.

BACKGROUND: Community Advisory Boards (CABs) have been frequently used to engage diverse partners to inform research projects. Yet, evaluating the quality of engagement has not been routine. We describe a multi-method ethnographic approach documenting and assessing partner engagement in two "virtual" CABs, for which we conducted all meetings remotely. METHODS: Two research projects for increasing equitable COVID-19 testing, vaccination, and clinical trial participation for underserved communities involved remote CAB meetings. Thirty-three partners representing 17 community groups participated in 15 sessions across the two CABs facilitated by a social change organization. We developed ethnographic documentation forms to assess multiple aspects of CAB member engagement (e.g., time spent speaking, modality used, types of interactions). Documenters were trained to observe CAB sub-groups via virtual sessions. Debriefing with the documentation team after CAB meetings supported quality assurance and process refinement. CAB members completed a brief validated survey after each meeting to assess the quality and frequency of engagement. Content and rapid thematic analysis were used to analyze documentation data. Quantitative data were summarized as frequencies and means. Qualitative and quantitative findings were triangulated. RESULTS: A total of 4,540 interactions were identified across 15 meetings. The most frequent interaction was providing information (44%), followed by responding (37-38%). The quality and frequency of stakeholder engagement were rated favorably (average 4.7 of 5). Most CAB members (96%) reported good/excellent engagement. Specific comments included appreciation for the diversity of perspectives represented by the CAB members and suggestions for improved live interpretation. Debriefing sessions led to several methodological refinements for the documentation process and forms. CONCLUSION: We highlight key strategies for documenting and assessing community engagement. Our methods allowed for rich ethnographic data collection that refined our work with community partners. We recommend ongoing trainings, including debriefing sessions and routinely reviewed assessment of data to strengthen meaningful community engagement.

Identification of optimal thalassemia screening strategies for migrant populations in Thailand using a qualitative approach.

BACKGROUND: Thalassemia is a common inherited hemoglobin disorder in Southeast Asia. Severe thalassemia can lead to significant morbidity for patients and economic strain for under-resourced health systems. Thailand's thalassemia prevention and control program has successfully utilized prenatal screening and diagnosis to reduce the incidence of severe thalassemia in Thai populations, but migrant populations are excluded despite having high thalassemia prevalence. We sought to identify key barriers to and facilitators of thalassemia screening and to develop tailored recommendations for providing migrants with access to thalassemia prevention and control. METHODS: We conducted 28 in-depth interviews and 4 focus group discussions (FGDs) in Chonburi, Thailand with Myanmar and Cambodian migrants, Thai healthcare providers, Thai parents of children affected by thalassemia, and migrant agents. RESULTS: Participant narratives revealed that migrants' lack of knowledge about the prevalence, manifestations, severity, and inherited nature of thalassemia led to misconceptions, fear, or indifference toward thalassemia and screening. Negative perceptions of pregnancy termination were based in religious beliefs but compounded by other sociocultural factors, presenting a key obstacle to migrant uptake of prenatal screening. Additionally, structural barriers included legal status, competing work demands, lack of health insurance, and language barriers. Participants recommended delivering public thalassemia education in migrants' native languages, implementing carrier screening, and offering thalassemia screening in convenient settings. CONCLUSIONS: An effective thalassemia prevention and control program should offer migrants targeted thalassemia education and outreach, universal coverage for thalassemia screening and prenatal care, and options for carrier screening, providing a comprehensive strategy for reducing the incidence of severe thalassemia in Thailand and establishing an inclusive model for regional thalassemia prevention and control.

Traditional Healers and Mental Health in Nepal: A Scoping Review.

Despite extensive ethnographic and qualitative research on traditional healers in Nepal, the role of traditional healers in relation to mental health has not been synthesized. We focused on the following clinically based research question, "What are the processes by which Nepali traditional healers address mental well-being?" We adopted a scoping review methodology to maximize the available literature base and conducted a modified thematic analysis rooted in grounded theory, ethnography, and phenomenology. We searched five databases using terms related to traditional healers and mental health. We contacted key authors and reviewed references for additional literature. Our scoping review yielded 86 eligible studies, 65 of which relied solely on classical qualitative study designs. The reviewed literature suggests that traditional healers use a wide range of interventions that utilize magico-religious explanatory models to invoke symbolic transference, manipulation of local illness narratives, roles, and relationships, cognitive restructuring, meaning-making, and catharsis. Traditional healers' perceived impact appears greatest for mild to moderate forms of psychological distress. However, the methodological and sample heterogeneity preclude uniform conclusions about traditional healing. Further research should employ methods which are both empirically sound and culturally adapted to explore the role of traditional healers in mental health.

Agricultural wealth better predicts mental wellbeing than market wealth among highly vulnerable households in Haiti: Evidence for the benefits of a multidimensional approach to poverty.

OBJECTIVES: Lack of wealth (poverty) impacts almost every aspect of human biology. Accordingly, many studies include its assessment. In almost all cases, approaches to assessing poverty are based on lack of success within cash economies (eg, lack of income, employment). However, this operationalization deflects attention from alternative forms of poverty that may have the most substantial influence on human wellbeing. We test how a multidimensional measure of poverty that considers agricultural assets expands the explanatory power of the construct of household poverty by associating it with one key aspect of wellbeing: symptoms of mental health. METHODS: We used the case of three highly vulnerable but distinctive communities in Haiti-urban, town with a rural hinterland, and rural. Based on survey responses from adults in 4055 geographically sampled households, linear regression models were used to predict depression and anxiety symptom levels controlling for a wide range of covariates related to detailed measures of material poverty, including cash-economy and agricultural assets, income, financial stress, and food insecurity. RESULTS: Household assets related to the cash economy were significantly associated with lower (ie, better) depression scores (-0.7, [95% CI: -1.2 to, -0.1]) but unrelated to anxiety scores (-0.3 [95% CI: -0.8 to 0.3]). Agricultural wealth was significantly-and more strongly-associated with both reductions in depression symptoms (-1.4 [95% CI: -2.2 to -0.7]) and anxiety symptoms (-1.8 [95% CI: -2.6 to -1.0]). These associations were consistent across the three sites, except in the fully urban site in Port-au-Prince where level of depression symptoms was not significantly associated with household agricultural wealth. CONCLUSIONS: Standard measures of poverty based on success in the cash economy can mask important associations between poverty and wellbeing, in this case related to household-level subsistence capacity and crucial food-producing household assets.

Perceived Feasibility, Acceptability, and Cultural Adaptation for a Mental Health Intervention in Rural Haiti.

Mental healthcare is largely unavailable throughout Haiti, particularly in rural areas. The aim of the current study is to explore perceived feasibility, acceptability, and effectiveness of potential culturally adapted interventions to improve mental health among Haitian women. The study used focus group discussions (n = 12) to explore five potential interventions to promote mental health: individual counseling, income-generating skills training, peer support groups, reproductive health education, and couples' communication training. Findings indicate that individual counseling, support group, and skills training components were generally anticipated to be effective, acceptable, and feasible by both male and female participants. That being said, participants expressed doubts regarding the acceptability of the couples' communication training and reproductive health education due to: a perceived lack of male interest, traditional male and female gender roles, lack of female autonomy, and misconceptions about family planning. Additionally, the feasibility, effectiveness, and acceptability of the components were described as dependent on cost, proximity to participants, and inclusion of a female health promoter that is known in the community. Given the lack of research on intervention approaches in Haiti, particularly those targeting mental health, this study provides a foundation for developing prevention and treatment approaches for mental distress among Haitian women.

Validating mental health assessment in Kenya using an innovative gold standard.

With the growing burden of mental health disorders worldwide, alongside efforts to expand availability of evidence-based interventions, strategies are needed to ensure accurate identification of individuals suffering from mental disorders. Efforts to locally validate mental health assessments are of particular value, yet gold-standard clinical validation is costly, time-intensive, and reliant on available professionals. This study aimed to validate assessment items for mental distress in Kenya, using an innovative gold standard and a combination of culturally adapted and locally developed items. The mixed-method study drew on surveys and semi-structured interviews, conducted by lay interviewers, with 48 caregivers. Interviews were used to designate mental health "cases" or "non-cases" based on emotional health problems, identified through a collaborative clinical rating process with local input. Individual mental health survey items were evaluated for their ability to discriminate between cases and non-cases. Discriminant survey items included 23 items adapted from existing mental health assessment tools, as well as 6 new items developed for the specific cultural context. When items were combined into a scale, results showed good psychometric properties. The use of clinically rated semi-structured interviews provides a promising alternative gold standard that can help address the challenges of conducting diagnostic clinical validation in low-resource settings.

What Influences Saturation? Estimating Sample Sizes in Focus Group Research.

Saturation is commonly used to determine sample sizes in qualitative research, yet there is little guidance on what influences saturation. We aimed to assess saturation and identify parameters to estimate sample sizes for focus group studies in advance of data collection. We used two approaches to assess saturation in data from 10 focus group discussions. Four focus groups were sufficient to identify a range of new issues (code saturation), but more groups were needed to fully understand these issues (meaning saturation). Group stratification influenced meaning saturation, whereby one focus group per stratum was needed to identify issues; two groups per stratum provided a more comprehensive understanding of issues, but more groups per stratum provided little additional benefit. We identify six parameters influencing saturation in focus group data: study purpose, type of codes, group stratification, number of groups per stratum, and type and degree of saturation.

Cholera control and anti-Haitian stigma in the Dominican Republic: from migration policy to lived experience.

As cholera spread from Haiti to the Dominican Republic, Haitian migrants, a largely undocumented and stigmatized population in Dominican society, became a focus of public health concern. Concurrent to the epidemic, the Dominican legislature enacted new documentation requirements. This paper presents findings from an ethnographic study of anti-Haitian stigma in the Dominican Republic from June to August 2012. Eight focus group discussions (FGDs) were held with Haitian and Dominican community members. Five in-depth interviews were held with key informants in the migration policy sector. Theoretical frameworks of stigma's moral experience guided the analysis of how cholera was perceived, ways in which blame was assigned and felt and the relationship between documentation and healthcare access. In FGDs, both Haitians and Dominicans expressed fear of cholera and underscored the importance of public health messages to prevent the epidemic's spread. However, health messages also figured into experiences of stigma and rationales for blame. For Dominicans, failure to follow public health advice justified the blame of Haitians and seemed to confirm anti-Haitian sentiments. Haitians communicated a sense of powerlessness to follow public health messages given structural constraints like lack of safe water and sanitation, difficulty accessing healthcare and lack of documentation. In effect, by making documentation more difficult to obtain, the migration policy undermined cholera programs and contributed to ongoing processes of moral disqualification. Efforts to eliminate cholera from the island should consider how policy and stigma can undermine public health campaigns and further jeopardize the everyday 'being-in-the-world' of vulnerable groups.

Retention in HIV care depends on patients' perceptions of the clinic experience.

Institutional barriers in HIV primary care settings can contribute substantially to disparities in retention in HIV treatment and HIV-related outcomes. This qualitative study compared the perceptions of clinic experiences of persons living with HIV (PLWH) in a Veterans Affairs HIV primary care clinic setting who were retained in care with the experiences of those who were not retained in care. Qualitative data from 25 in-depth interviews were analyzed to identify facilitators and barriers to retention in HIV care. Results showed that participants not retained in care experienced barriers to retention involving dissatisfaction with clinic wait times, low confidence in clinicians, and customer service concerns. For participants retained in care, patience with procedural issues, confidence in clinicians, and interpersonal connections were factors that enhanced retention despite the fact that these participants recognized the same barriers as those who were not retained in care. These findings can inform interventions aimed at improving retention in HIV care.

Measuring material wealth in low-income settings: A conceptual and how-to guide.

Although wealth is consistently found to be an important predictor of health and well-being, there remains debate as to the best way to conceptualize and operationalize wealth. In this article, we focus on the measurement of economic resources, which is one among many forms of wealth. We provide an overview of the process of measuring material wealth, including theoretical and conceptual considerations, a how-to guide based on the most common approach to measurement, and a review of important theoretical and empirical questions that remain to be resolved. Throughout, we emphasize considerations particular to the settings in which anthropologists work, and we include variations on common approaches to measuring material wealth that might be better suited to anthropologists' theoretical questions, methodological approaches, and fieldwork settings.

Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough?

Saturation is a core guiding principle to determine sample sizes in qualitative research, yet little methodological research exists on parameters that influence saturation. Our study compared two approaches to assessing saturation: code saturation and meaning saturation. We examined sample sizes needed to reach saturation in each approach, what saturation meant, and how to assess saturation. Examining 25 in-depth interviews, we found that code saturation was reached at nine interviews, whereby the range of thematic issues was identified. However, 16 to 24 interviews were needed to reach meaning saturation where we developed a richly textured understanding of issues. Thus, code saturation may indicate when researchers have "heard it all," but meaning saturation is needed to "understand it all." We used our results to develop parameters that influence saturation, which may be used to estimate sample sizes for qualitative research proposals or to document in publications the grounds on which saturation was achieved.

Perceived discrimination, humiliation, and mental health: a mixed-methods study among Haitian migrants in the Dominican Republic.

OBJECTIVE: Many Haitian migrants live and work as undocumented laborers in the Dominican Republic. This study examines the legacy of anti-Haitian discrimination in the Dominican Republic and association of discrimination with mental health among Haitian migrants. DESIGN: This study used mixed methods to generate hypotheses for associations between discrimination and mental health of Haitian migrants in the Dominican Republic. In-depth interviews were conducted with 21 Haitian and 18 Dominican community members and clinicians. One hundred and twenty-seven Haitian migrants participated in a pilot cross-sectional community survey. Instruments included culturally adapted Kreyòl versions of the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) and a locally developed function impairment scale. RESULTS: Haitian migrants described humiliation (imilyasyon) as a reason for mental distress and barrier to health care. Dominicans reported that discrimination (discriminación) was not a current social problem and attributed negative social interactions to sociocultural, behavioral, and biological differences between Dominicans and Haitians. These qualitative findings were supported in the quantitative analyses. Perceived discrimination was significantly associated with depression severity and functional impairment. Perceived mistreatment by Dominicans was associated with a 6.6-point increase in BDI score (90% confidence interval [CI]: 3.29, 9.9). Knowing someone who was interrogated or deported was associated with a 3.4-point increase in BAI score (90% CI: 0.22, 6.64). CONCLUSION: Both qualitative and quantitative methods suggest that perceived discrimination and the experience of humiliation contribute to Haitian migrant mental ill-health and limit access to health care. Future research should evaluate these associations and identify intervention pathways for both improved treatment access and reduction of discrimination-related health risk factors.

Social stressors, social support, and mental health among Haitian migrants in the Dominican Republic.

This mixed-method study explored the social world of Haitian migrants, examining forms of social support and social stress, as well as their relationship to mental health. Among six Haitian migrant communities in the Cibao Valley of the Dominican Republic, a community-based survey (n = 127) was conducted to assess migration experiences, current stressors, mental health, and functioning. In addition, to explore perceptions and experiences of migration, social interactions, and mental health, the study drew upon in-depth interviews and free-listing activities among Haitian migrants, as well as cognitive interviews with select survey participants. Depressive, anxiety, and mental distress survey scores were associated with 1) negative social interactions (including interrogation or deportation, perceived mistreatment by Dominicans, and overcrowding) and 2) lack of social support, including migrating alone. Mental distress scores were higher among women, and being married was associated with higher anxiety scores, potentially reflecting unmet social expectations. In qualitative data, participants emphasized a lack of social support, often referred to as tèt ansanm (literally meaning "heads together" in Haitian Creole or Kreyòl and roughly defined as solidarity or reciprocal social collaboration). The authors of the study propose that the practice of tèt ansanm-also termed konbit, and, in the Dominican Republic, convite-could be used as a means of facilitating positive-contact events among Haitians and Dominicans. These interactions could help counteract social stress and build social capital in settings similar to those of the study.

Reflechi twòp--thinking too much: description of a cultural syndrome in Haiti's Central Plateau.

A rich Haitian ethnopsychology has been described, detailing concepts of personhood, explanatory models of illness, and links between mind and body. However, little research has engaged explicitly with mental illness, and that which does focuses on the Kreyòl term fou (madness), a term that psychiatrists associate with schizophrenia and other psychoses. More work is needed to characterize potential forms of mild-to-moderate mental illness. Idioms of distress provide a promising avenue for exploring common mental disorders. Working in Haiti's Central Plateau, we aimed to identify idioms of distress that represent cultural syndromes. We used ethnographic and epidemiologic methods to explore the idiom of distress reflechi twòp (thinking too much). This syndrome is characterized by troubled rumination at the intersection of sadness, severe mental disorder, suicide, and social and structural hardship. Persons with "thinking too much" have greater scores on the Beck Depression Inventory and Beck Anxiety Inventory. "Thinking too much" is associated with 8 times greater odds of suicidal ideation. Untreated "thinking too much" is sometimes perceived to lead to psychosis. Recognizing and understanding "thinking too much" may allow early clinical recognition and interventions to reduce long-term psychosocial suffering in Haiti's Central Plateau.

Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors.

INTRODUCTION: Children, adolescent, and young adult cancer survivors experience overall increased risks of infertility that are preventable through effective fertility preservation services prior to starting cancer treatment. Oncofertility care is the evidence-based practice of informing newly diagnosed cancer patients about their reproductive risks and supporting shared decision-making on fertility preservation services. Despite longstanding clinical guidelines, oncofertility care delivery continues to be limited and highly variable across adult and pediatric oncology settings. MATERIALS AND METHODS: We describe the design of a stepped wedge cluster randomized clinical trial to evaluate the effectiveness of the multi-component Telehealth Oncofertility Care (TOC) intervention conducted in 20 adult and pediatric oncology clinics across three health systems in Southern California. Intervention components are: 1) electronic health record-based oncofertility needs screen and referral pathway to a virtual oncofertility hub; 2) telehealth oncofertility counseling through the hub; and 3) telehealth oncofertility financial navigation through the hub. We hypothesize the intervention condition will be associated with increased proportions of patients who engage in goal-concordant oncofertility care (i.e., engagement in reproductive risk counseling and fertility preservation services that meet the patient's fertility goals) and improved patient-reported outcomes, compared to the usual care control condition. We will also evaluate intervention implementation in a mixed-methods study guided by implementation science frameworks. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention at cancer diagnosis for children, adolescent and young adult cancer patients to improve their future fertility and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05443737.

Implementation of state health insurance benefit mandates for cancer-related fertility preservation: following policy through a complex system.

BACKGROUND: A myriad of federal, state, and organizational policies are designed to improve access to evidence-based healthcare, but the impact of these policies likely varies due to contextual determinants of, reinterpretations of, and poor compliance with policy requirements throughout implementation. Strategies enhancing implementation and compliance with policy intent can improve population health. Critically assessing the multi-level environments where health policies and their related health services are implemented is essential to designing effective policy-level implementation strategies. California passed a 2019 health insurance benefit mandate requiring coverage of fertility preservation services for individuals at risk of infertility due to medical treatments, in order to improve access to services that are otherwise cost prohibitive. Our objective was to document and understand the multi-level environment, relationships, and activities involved in using state benefit mandates to facilitate patient access to fertility preservation services. METHODS: We conducted a mixed-methods study and used the policy-optimized exploration, preparation, implementation, and sustainment (EPIS) framework to analyze the implementation of California's fertility preservation benefit mandate (SB 600) at and between the state insurance regulator, insurer, and clinic levels. RESULTS: Seventeen publicly available fertility preservation benefit mandate-relevant documents were reviewed. Interviews were conducted with four insurers; 25 financial, administrative, and provider participants from 16 oncology and fertility clinics; three fertility pharmaceutical representatives; and two patient advocates. The mandate and insurance regulator guidance represented two "Big P" (system level) policies that gave rise to a host of "little p" (organizational) policies by and between the regulator, insurers, clinics, and patients. Many little p policies were bridging factors to support implementation across levels and fertility preservation service access. Characterizing the mandate's functions (i.e., policy goals) and forms (i.e., ways that policies were enacted) led to identification of (1) intended and unintended implementation, service, and patient outcomes, (2) implementation processes by level and EPIS phase, (3) actor-delineated key processes and heterogeneity among them, and (4) inner and outer context determinants that drove adaptations. CONCLUSIONS: Following the midstream and downstream implementation of a state health insurance benefit mandate, data generated will enable development of policy-level implementation strategies, evaluation of determinants and important outcomes of effective implementation, and design of future mandates to improve fit and fidelity.

Assessing ad-hoc adaptations' alignment with therapeutic goals: a qualitative study of lay counselor-delivered family therapy in Eldoret, Kenya.

BACKGROUND: A key question in implementation science is how to balance adaptation and fidelity in translating interventions to new settings. There is growing consensus regarding the importance of planned adaptations to deliver interventions in contextually sensitive ways. However, less research has examined ad-hoc adaptations, or those that occur spontaneously in the course of intervention delivery. A key question is whether ad-hoc adaptations ultimately contribute to or detract from intervention goals. This study aimed to (a) identify ad-hoc adaptations made during delivery of a family therapy intervention and (b) assess whether they promoted or interrupted intervention goals. METHODS: Tuko Pamoja (Swahili: "We are Together") is an evidence-informed family therapy intervention aiming to improve family dynamics and mental health in Kenya. Tuko Pamoja employs a task-shifting model, delivered by lay counselors who are afforded a degree of flexibility in presenting content and in practices they use in sessions. We used transcripts of therapy sessions with 14 families to examine ad-hoc adaptations used by counselors. We first identified and characterized ad-hoc adaptations through a team-based code development, coding, and code description process. Then, we evaluated to what extent ad-hoc adaptations promoted the principles and strategies of the intervention ("TP-promoting"), disrupted them ("TP-interrupting"), or neither ("TP-neutral"). To do this, we first established inter-coder agreement on application of these categories with verification by the intervention developer. Then, coders categorized ad-hoc adaptation text segments as TP-promoting, TP-interrupting, or TP-neutral. RESULTS: Ad-hoc adaptations were frequent and included (in decreasing order): incorporation of religious content, exemplars/role models, community dynamics and resources, self-disclosure, and metaphors/proverbs. Ad-hoc adaptations were largely TP-promoting (49%) or neutral (39%), but practices were TP-interrupting 12% of the time. TP-interrupting practices most often occurred within religious content and exemplars/role models, which were also the most common practices overall. CONCLUSION: Extra attention is needed during planned adaptation, training, and supervision to promote intervention-aligned use of common ad-hoc adaptation practices. Discussing them in trainings can provide guidance for lay providers on how best to incorporate ad-hoc adaptations during delivery. Future research should evaluate whether well-aligned ad-hoc adaptations improve therapeutic outcomes. TRIAL REGISTRATION: Pilot trial registered at clinicaltrials.gov (C0058).

Development, Usability Testing, and Implementation Assessment of Cancer Related Infertility Score Predictor, an Online Cancer Related Infertility Risk Counseling Tool.

Purpose: Oncofertility counseling of female cancer patients lacks efficient access to tailored and valid infertility risk estimates to support shared decision-making on fertility preservation treatments. The objective was to develop, conduct user-centered design, and plan clinic-based implementation of the Cancer Related Infertility Score Predictor (CRISP), a web-based tool to support infertility risk counseling. Methods: Using a mixed methods design, literature review was undertaken to abstract data on infertility, primary ovarian insufficiency, and amenorrhea risks of common cancer treatments. The CRISP website was programmed to take user input about patient ages and cancer treatments and generate a risk summary. Using user experience methodology and semistructured interviews, usability testing and implementation assessment were conducted with 12 providers recruited from 5 medical centers in Southern California. Results: The web-based CRISP tool encompasses infertility risk data for 60 treatment regimens among 10 cancer types. Usability testing demonstrated that the tool is intuitive and informed minor modifications, including adding crowd-sourced submission of additional cancer treatments. Participants rated the tool as credible, advantageous over current provider methods to ascertain infertility risks, and useful for tailoring treatment planning and counseling patients. A key barrier was lack of information on some cancer treatments. Fit within clinical workflow was feasible, particularly with electronic health record integration. Conclusions: The novel, web-based CRISP tool is a feasible, acceptable, and appropriate tool to address provider knowledge gap about cancer related infertility risks and use for patient counseling. CRISP has significant potential to support tailored oncofertility counseling in the heterogeneous young cancer patient population.

A Multicomponent Telehealth Intervention to Improve Oncofertility Care Delivery Among Young Cancer Patients: A Pilot Study.

Purpose: Oncofertility care for pediatric, adolescent, and young adult cancer patients remains under-implemented across adult and pediatric oncology settings. We pilot tested an electronic health record (EHR)-enabled multicomponent oncofertility intervention (including screening, referral, and fertility consult) in an adult academic oncology program and systematically assessed intervention fit to pediatric and community oncology programs. Methods: Using surveys (n = 33), audits (n = 143), and interviews (n = 21) guided by implementation science frameworks, we pilot tested the EHR-enabled intervention for oncofertility care in young cancer patients at an adult oncology program and evaluated implementation outcomes. We interviewed health care providers from seven regional oncology and fertility programs about intervention fit to their clinical contexts. Results: We recruited 33 health care providers from an adult oncology setting and 15 health care providers from seven additional oncology and fertility settings. At the adult oncology setting, the intervention was found to be appropriate, acceptable, and feasible and improved the screening of fertility needs (from 30% pre- to 51% post-intervention); yet, some patients did not receive appropriate referrals to fertility consults. Providers across all settings suggested content and context modifications, such as adding options to the intervention or allowing the screening component to pop up at a second visit, to improve and adapt the intervention to better fit their clinical care contexts. Conclusions: We found that the EHR-enabled intervention increased the rate of goal-concordant oncofertility care delivery at an adult oncology program. We also identified facilitators, barriers, and needed adaptations to the intervention required for implementation and scaling-up across diverse oncology settings.

Intervening on women's health for rural young breast cancer survivors: A study protocol.

INTRODUCTION: From diagnosis to post-treatment, many young breast cancer survivors (YBCS) experience infertility, limited contraception choices, concern about pregnancy safety, and menopausal symptoms. Clinical guidelines recommend oncofertility care (counseling and/or clinical services that meet fertility, contraception, pregnancy health and/or menopausal symptom management needs) throughout the cancer care continuum. However, significant oncofertility care gaps exist in rural, community oncology settings. MATERIALS AND METHODS: We describe the design of an interrupted time series, effectiveness-implementation hybrid clinical trial that evaluates a multi-component intervention to improve YBCS engagement in oncofertility care. The intervention is comprised of 1) oncology clinic-based oncofertility needs screen; 2) a women's health survivorship care plan in Spanish and English; 3) remote patient navigation; and 4) telehealth oncofertility consultation. During the pre-intervention period (12 months), usual care will be delivered. During the intervention period (15 months), the multi-component intervention will be implemented at two rural oncology clinics with largely Latina, Spanish-speaking populations. The primary outcome of YBCS (n = 135) engagement in oncofertility care will be collected from medical record review. We will also collect validated patient-reported outcomes. Informed by the Exploration Preparation Implementation Sustainment (EPIS) implementation science framework, we will integrate qualitative and quantitative data to explore whether and how the intervention was effective, acceptable, appropriate, and delivered with fidelity. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention for YBCS in underserved areas to reduce disparities and improve reproductive health and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05414812.