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, re-interpretations 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 (FP) services for individuals at risk of infertility due to medical treatments to improve access to services that are otherwise cost-prohibitive. Our objective was to document and understand multi-level environment, relationships, and activities involved in using state benefit mandates to facilitate patient access to FP services. Methods: We conducted a mixed-methods study and used the policy-optimized Exploration, Preparation, Implementation, Sustainment (EPIS) framework to analyze 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 FP benefit mandate-relevant documents were reviewed, and four insurers, 25 financial, administrative and provider participants from 16 oncology and fertility clinics, three fertility pharmaceutical representatives, and two patient advocates were interviewed. 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 FP 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, EPIS phase; (3) actor-delineated key processes and heterogeneity among them; and (4) inner and outer context determinants that drove adaptations. Conclusions: Following the mid- and down-stream 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.

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors.

Younger breast cancer survivors (YBCS) consistently report poorer quality of life (QOL) than older survivors. Increasing physical activity (PA) may improve QOL, but this has been understudied in YBCS. This single arm pilot study evaluated the feasibility and acceptability of a 3-month, peer-delivered, remote intervention to increase PA and improve QOL in YBCS. Data were collected from October 2019 - July 2020. Participants (n = 34, 43.1 ± 5.5 years old, 46 ± 34.4 months post-diagnosis, BMI = 30.2 ± 7.4 kg/m2) completed six video sessions with a trained peer mentor; self-monitored PA with a Fitbit activity tracker; and interacted with a private Fitbit Community for social support. At baseline, 3-and 6-months, participants completed QOL questionnaires and PA was measured through accelerometer (moderate-to-vigorous PA [MVPA]) and self-report (strength and flexibility). A parallel mixed-methods approach (qualitative interviews and quantitative satisfaction survey at 3-months) explored intervention feasibility and acceptability. One-way repeated-measures ANOVAs examined impacts on PA and QOL at 3-and 6-months. The intervention was feasible as evidenced by efficient recruitment, high retention, and adherence to intervention components. Remote delivery, working with a peer mentor, and using Fitbit tools were highly acceptable. From baseline to 3-months, participants increased time spent in objectively measured MVPA, strength, and flexibility exercises, and reported meaningful improvements to body image, fatigue, anxiety, and emotional support. A fully remote, peer-to-peer intervention is an acceptable and promising strategy to increase PA and improve QOL in YBCS. Refinements to the intervention and its delivery should be further assessed in future studies, toward the goal of disseminating an evidence-based, scalable intervention to the growing number of YBCS.Trial registration Prospectively registered as NCT04064892.

Efficacy of a web-based women's health survivorship care plan for young breast cancer survivors: a randomized controlled trial.

PURPOSE: Breast cancer survivorship care plans (SCP) have limited content addressing women's health issues. This trial tested if young breast cancer survivors who receive a web-based, women's health SCP were more likely to improve on at least one of the four targeted issues (hot flashes, fertility-related concerns, contraception, and vaginal symptoms) compared to attention controls. METHODS: A randomized controlled trial recruited female survivors ages 18-45 at diagnosis, 18-50 at enrollment, completed primary cancer treatment, and had a significant women's health issue: moderate or higher fertility-related concerns; ≥ 4 hot flashes/day with ≥ 1 of moderate severity; ≥ 1 moderate vaginal atrophy symptoms; or not contracepting/using less effective methods. Survivors underwent stratified, block randomization with equal allocation to intervention and control groups. The intervention group accessed the online SCP; controls accessed curated resource lists. In intention-to-treat analysis, the primary outcome of improvement in at least one issue by 24 weeks was compared by group. RESULTS: 182 participants (86 intervention, 96 control), mean age 40.0 ± 5.9 and 4.4 ± 3.2 years since diagnosis, were randomized. 61 intervention group participants (70.9%) improved, compared to 55 controls (57.3%) (OR 1.82, 95% CI 0.99-3.4, p = 0.057). The following issue-specific improvements were observed in the intervention versus control arms: fertility-related concerns (27.9% vs. 14.6%, OR 2.3, 95% CI 1.1-4.8); hot flashes (58.5% vs. 55.8%, OR 1.1, 95% CI 0.57-2.2); vaginal symptoms (42.5% vs. 40.7%, OR 1.1, 95% CI 0.6-2.0); contraception (50% vs. 42.6%, OR 1.4, 95% CI 0.74-2.5). CONCLUSIONS: In young breast cancer survivors, a novel, web-based SCP did not result in more change in the primary outcome of improvement in at least one of the four targeted women's health issues, than the attention control condition. The intervention was associated with improved infertility concerns, supporting efficacy of disseminating accessible, evidence-based women's health information to this population.

Oncofertility: Meeting the Fertility Goals of Adolescents and Young Adults With Cancer.

Adolescents and young adults aged 15 to 39 years who are diagnosed with cancer (AYA survivors) undergo a range of therapies for cancer cure but subsequently may be at risk of treatment-related infertility, and for female AYA survivors, adverse pregnancy outcomes. Future fertility is important to AYA survivors. Meeting their fertility goals requires awareness of this importance, knowledge of cancer treatment-related fertility risks, appropriate fertility counseling on these risks, and access to fertility care. Epidemiologic and dissemination and implementation research are needed to estimate more precise risks of traditional and novel cancer therapies on fertility and pregnancy outcomes and improve the delivery of fertility care.

The National Physicians Cooperative: transforming fertility management in the cancer setting and beyond.

Once unimaginable, fertility management is now a nationally established part of cancer care in institutions, from academic centers to community hospitals to private practices. Over the last two decades, advances in medicine and reproductive science have made it possible for men, women and children to be connected with an oncofertility specialist or offered fertility preservation soon after a cancer diagnosis. The Oncofertility Consortium's National Physicians Cooperative is a large-scale effort to engage physicians across disciplines - oncology, urology, obstetrics and gynecology, reproductive endocrinology, and behavioral health - in clinical and research activities to enable significant progress in providing fertility preservation options to children and adults. Here, we review the structure and function of the National Physicians Cooperative and identify next steps.

Developing a post-treatment survivorship care plan to help breast cancer survivors understand their fertility.

PURPOSE: Reproductive-aged breast cancer survivors (BCS) who have completed initial cancer treatment frequently want to know about their future fertility potential. The purpose of this qualitative study was to assess if the fertility-related content presented in the survivorship care plan prototype met the informational needs of post-treatment BCS and to provide an opportunity for the target audience to review and react to the proposed content and design. METHODS: We conducted and analyzed transcripts from seven focus groups with BCS to evaluate their reactions to the survivorship care plan prototype. We independently coded transcripts for consistent themes and sub-themes and used a consensus-building approach to agree on interpretation of results. RESULTS: We identified five themes that describe the post-treatment BCS' responses to the prototype survivorship care plan in the context of their informational needs and experiences: (1) the prototype's fertility-related information is relevant; (2) desire for clinical parameters to help survivors understand their infertility risk; (3) fertility-related information is important throughout survivorship; (4) evidence-based content from a neutral source is trustworthy; and (5) the recommendation to see a fertility specialist is helpful, but cost is a barrier. CONCLUSIONS: BCS have concerns and needs related to their fertility potential after initial breast cancer treatment. The evidence-based information offered in our prototype survivorship care plan was acceptable to BCS and has significant potential to address these needs. Additional primary data that identify post-cancer treatment indicators of fertility would advance this effort.

Validity of self-reported fertility-threatening cancer treatments in female young adult cancer survivors.

PURPOSE: Detailed cancer treatment information is important to fertility and pregnancy care of female young adult cancer survivors. Accuracy of self-report of treatments that impact fertility and pregnancy is unknown. This study assessed agreement between self-report and medical records on receipt of fertility-threatening treatments. METHODS: A national cohort study of female young adult cancer survivors reported cancer treatments via Web-based questionnaires. Primary cancer treatment records were abstracted. Self-reported exposure to fertility-threatening therapies (alkylating chemotherapy, stem cell transplant, pelvic radiation, hysterectomy, and/or oophorectomy) was compared to medical records. Logistic regression models estimated odds ratios (OR) for characteristics associated with inaccurate self-report of fertility-threatening therapies. RESULTS: The study included 101 survivors (mean age 28.2, SD 6.3). Lymphoma (33%), breast cancer (26%), and gynecologic cancers (10%) were the most common cancers. Accuracy of self-report was 68% for alkylating chemotherapy and 92-97% for radiation, surgery, and transplant. Significant proportions of survivors who were treated with transplant (8/13, 62%), alkylating chemotherapy (18/43, 42%), pelvic radiation (4/13, 31%), or hysterectomy and/or oophorectomy (3/13, 23%) did not report undergoing these therapies. In adjusted analysis, age ≤ 25 at diagnosis (OR 3.4, 95% CI 1.3-8.7) and recurrence (OR 6.0, 95% CI 1.5-24.4) were related to inaccurate self-report. CONCLUSIONS: Female young adult cancer survivors have limited recall of fertility-threatening cancer treatment exposures. Reproductive health providers and researchers who need this information may require primary medical records or treatment summaries. IMPLICATIONS FOR CANCER SURVIVORS: Additional patient education regarding treatment-related reproductive risks is needed to facilitate patient engagement in survivorship. Obtaining a cancer treatment summary will help survivors communicate their prior treatment exposures to reproductive healthcare providers.

Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

Decreased inhibin B responses following recombinant human chorionic gonadotropin administration in normal women and women with polycystic ovary syndrome.

OBJECTIVE: To determine whether granulosa cells contribute to excess androgen production, by assessing inhibin B (Inh B) responses to hCG in women with polycystic ovary syndrome (PCOS) and in normal women. DESIGN: Prospective study. SETTING: Academic medical center. PATIENT(S): Twenty women with PCOS and 16 normal women. INTERVENTION(S): Blood samples obtained before and 24 hours after injection of 25 µg recombinant hCG (r-hCG). MAIN OUTCOME MEASURE(S): Basal and stimulated Inh B, E2, androstenedione (A), and T responses after r-hCG administration. RESULT(S): In normal and PCOS women, r-hCG induced a significant reduction of Inh B levels. Lowered Inh B responses were not related to body mass index, PCOS status, or age by multivariate regression. Recombinant hCG significantly increased serum A and E2 in both normal and PCOS women. CONCLUSION(S): In normal and PCOS women, Inh B production was decreased following r-hCG administration. These findings strongly suggest that in PCOS women androgen excess is not enhanced by LH-stimulated Inh B production. CLINICAL TRIAL REGISTRATION NUMBER: NCT00747617.