Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).

BACKGROUND: Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled. METHODS: The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation. RESULTS: Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively). CONCLUSIONS: DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.

Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years.

BACKGROUND: Treatment with an aromatase inhibitor for 5 years as up-front monotherapy or after tamoxifen therapy is the treatment of choice for hormone-receptor-positive early breast cancer in postmenopausal women. Extending treatment with an aromatase inhibitor to 10 years may further reduce the risk of breast-cancer recurrence. METHODS: We conducted a double-blind, placebo-controlled trial to assess the effect of the extended use of letrozole for an additional 5 years. Our primary end point was disease-free survival. RESULTS: We enrolled 1918 women. After a median follow-up of 6.3 years, there were 165 events involving disease recurrence or the occurrence of contralateral breast cancer (67 with letrozole and 98 with placebo) and 200 deaths (100 in each group). The 5-year disease-free survival rate was 95% (95% confidence interval [CI], 93 to 96) with letrozole and 91% (95% CI; 89 to 93) with placebo (hazard ratio for disease recurrence or the occurrence of contralateral breast cancer, 0.66; P=0.01 by a two-sided log-rank test stratified according to nodal status, prior adjuvant chemotherapy, the interval from the last dose of aromatase-inhibitor therapy, and the duration of treatment with tamoxifen). The rate of 5-year overall survival was 93% (95% CI, 92 to 95) with letrozole and 94% (95% CI, 92 to 95) with placebo (hazard ratio, 0.97; P=0.83). The annual incidence rate of contralateral breast cancer in the letrozole group was 0.21% (95% CI, 0.10 to 0.32), and the rate in the placebo group was 0.49% (95% CI, 0.32 to 0.67) (hazard ratio, 0.42; P=0.007). Bone-related toxic effects occurred more frequently among patients receiving letrozole than among those receiving placebo, including a higher incidence of bone pain, bone fractures, and new-onset osteoporosis. No significant differences between letrozole and placebo were observed in scores on most subscales measuring quality of life. CONCLUSIONS: The extension of treatment with an adjuvant aromatase inhibitor to 10 years resulted in significantly higher rates of disease-free survival and a lower incidence of contralateral breast cancer than those with placebo, but the rate of overall survival was not higher with the aromatase inhibitor than with placebo. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov numbers, NCT00003140 and NCT00754845.).

Improving Research Literacy in Diverse Minority Populations with a Novel Communication Tool.

Racial/ethnic minorities are underrepresented in clinical research in the USA for multifarious reasons, including barriers to effective communication between researchers and potential research participants. To address the communication barriers between researchers and potential participants, we developed a Research Literacy Support (RLS) tool. The focus of this report is to present findings from the second and third phases of development that refined and assessed usability of the RLS tool. We utilized a mixed-methods approach that entailed iterative cognitive testing with participants (N = 52) from diverse racial/ethnic backgrounds and interviews with clinical research recruiters (N = 20) to modify and refine the design and content of the RLS tool (phase 2). This was followed by assessment of the usability of the RLS tool by 100 participants (phase 3). During phase 2, participants provided feedback about layout, word choice, and comprehension of the tool. In phase 3, participants recognized that they had gained knowledge about clinical research from the RLS tool, although they still had a substantial learning gap after using the tool, indicating an opportunity for further refinement. The RLS tool may help advance health equity by addressing communication barriers that may impede minority participation in clinical research.

Phase II Study of Everolimus in Metastatic Malignant Melanoma (NCCTG-N0377, Alliance).

LESSONS LEARNED: Everolimus does not have sufficient activity to justify its use as single agent in metastatic melanoma.Patients treated with 10 mg per day dose were most likely to require dose reductions.Everolimus appeared to reduce the numbers of regulatory T cells in approximately half of the treated patients; unfortunately, these effects were not correlated with clinical outcomes. BACKGROUND: Everolimus (RAD-001) is an orally active rapamycin analogue shown in preclinical data to produce cytostatic cell inhibition, which may be potentially beneficial in treating melanoma. We conducted a phase II study to evaluate the efficacy and safety of everolimus in patients with unresectable metastatic melanoma (MM). METHODS: This study included two cohorts; cohort 1 received 30 mg of everolimus by mouth (PO) weekly, and cohort 2 was dosed with 10 mg of everolimus PO daily. The endpoints of the study were safety, 16-week progression-free survival (PFS), overall survival (OS), and measures of immunomodulatory/antiangiogenic properties with therapy. Tumor samples before therapy and at week 8 of treatment were analyzed. Peripheral blood plasma or mononuclear cell isolates collected prior to therapy and at weeks 8 and 16 and at time of tumor progression were analyzed for vascular endothelial growth factor and regulatory T-cell (Treg) measurements. RESULTS: A total of 53 patients were enrolled in cohort 1 (n = 24) and cohort 2 (n = 29). Only 2 patients of the first 20 patients enrolled in cohort 2 had treatment responses (25%; 95% confidence interval, 8.6%-49.1%); this result did not allow full accrual to cohort 2, as the study was terminated for futility. Median OS was 12.2 months for cohort 1 versus 8.1 months in cohort 2; no PFS advantage was seen in either group (2.1 months vs. 1.8 months). Dose-limiting toxicities included grade 4 myocardial ischemia (3.4%); grade 3 fatigue, mucositis, and hyperglycemia (10.3%); and anorexia and anemia (6.9%). Everolimus significantly reduced the number of Tregs in approximately half of the treated patients; however, these effects were not correlated with clinical outcomes. CONCLUSION: Everolimus does not have sufficient single-agent activity in MM; however, we have identified evidence of biological activity to provide a potential rationale for future combination studies.

Lessons Learned from Native C.I.R.C.L.E., a Culturally Specific Resource.

Cancer is now the second leading cause of death among American Indians and Alaska Natives (AIAN), and trends in cancer-related mortality over the past 2 decades show inferior control in AIAN compared to non-Hispanic Whites. The American Indian/Alaska Native Cancer Information Resource Center and Learning Exchange (Native C.I.R.C.L.E.) was developed in the year 2000 as part of a comprehensive network of partnerships to develop, maintain, and disseminate culturally appropriate cancer and other health information materials for AIAN educators and providers. Now, in its 15th year of existence, enough data has been accumulated by Native C.I.R.C.L.E. to analyze trends in the distribution of culturally relevant cancer information materials and compare access to both printed (hard copy) and online materials. The amount of culturally appropriate materials available since its creation has increased more than 10-fold. Print materials are now distributed throughout the world, and the number of materials requested from print and downloads combined are in the thousands on a monthly basis. Native C.I.R.C.L.E. is in the process of expanding its access and capabilities to target more of the lay AIAN public in order to address the digital divide.

Ovarian and uterine cancer incidence and mortality in American Indian and Alaska Native women, United States, 1999-2009.

OBJECTIVES: We examined geographic differences and trends in incidence and mortality of ovarian and uterine cancer in American Indian/Alaska Native (AI/AN) women. METHODS: We linked mortality data (1990-2009) and incidence data (1999-2009) to Indian Health Service (IHS) records. Death (and incidence) rates for ovarian and uterine cancer were examined for AI/AN and White women; Hispanics were excluded. Analyses focused on Contract Health Service Delivery Area (CHSDA) counties. RESULTS: AI/AN and White women had similar ovarian and uterine cancer death rates. Ovarian and uterine cancer incidence and death rates were higher for AI/ANs residing in CHSDA counties than for all US counties. We also observed geographic differences, regardless of CHSDA residence, in ovarian and uterine cancer incidence and death rates in AI/AN women by IHS region; Pacific Coast and Southern Plains women had higher ovarian cancer death rates and Northern Plains women had higher uterine cancer death rates. CONCLUSIONS: Regional differences in the incidence and mortality of ovarian and uterine cancers among AI/AN women in the United States were significant. More research among correctly classified AI/AN women is needed to understand these differences.

Breast cancer mortality among American Indian and Alaska Native women, 1990-2009.

OBJECTIVES: We compared breast cancer death rates and mortality trends among American Indian/Alaska Native (AI/AN) and White women using data for which racial misclassification was minimized. METHODS: We used breast cancer deaths and cases linked to Indian Health Service (IHS) data to calculate age-adjusted rates and 95% confidence intervals (CIs) by IHS-designated regions from 1990 to 2009 for AI/AN and White women; Hispanics were excluded. Mortality-to-incidence ratios (MIR) were calculated for 1999 to 2009 as a proxy for prognosis after diagnosis. RESULTS: Overall, the breast cancer death rate was lower in AI/AN women (21.6 per 100,000) than in White women (26.5). However, rates in AI/ANs were higher than rates in Whites for ages 40 to 49 years in the Alaska region, and ages 65 years and older in the Southern Plains region. White death rates significantly decreased (annual percent change [APC] = -2.1; 95% CI = -2.3, -2.0), but regional and overall AI/AN rates were unchanged (APC = 0.9; 95% CI = 0.1, 1.7). AI/AN women had higher MIRs than White women. CONCLUSIONS: There has been no improvement in death rates among AI/AN women. Targeted screening and timely, high-quality treatment are needed to reduce mortality from breast cancer in AI/AN women.

Disparities in cancer mortality and incidence among American Indians and Alaska Natives in the United States.

OBJECTIVES: We used improved data on American Indian and Alaska Native (AI/AN) ancestry to provide an updated and comprehensive description of cancer mortality and incidence among AI/AN populations from 1990 to 2009. METHODS: We linked the National Death Index and central cancer registry records independently to the Indian Health Service (IHS) patient registration database to improve identification of AI/AN persons in cancer mortality and incidence data, respectively. Analyses were restricted to non-Hispanic persons residing in Contract Health Service Delivery Area counties in 6 geographic regions of the United States. We compared age-adjusted mortality and incidence rates for AI/AN populations with White populations using rate ratios and mortality-to-incidence ratios. Trends were described using joinpoint analysis. RESULTS: Cancer mortality and incidence rates for AI/AN persons compared with Whites varied by region and type of cancer. Trends in death rates showed that greater progress in cancer control was achieved for White populations compared with AI/AN populations over the last 2 decades. CONCLUSIONS: Spatial variations in mortality and incidence by type of cancer demonstrated both persistent and emerging challenges for cancer control in AI/AN populations.

A randomized phase 2 study of temozolomide and bevacizumab or nab-paclitaxel, carboplatin, and bevacizumab in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group study, N0775.

BACKGROUND: Increasing evidence shows chemotherapy in combination with vascular endothelial growth factor (VEGF) inhibition is a clinically active therapy for patients with metastatic melanoma (MM). METHODS: A phase 2 trial was conducted in chemotherapy-naive patients with unresectable stage IV MM who were randomized to temozolomide (200 mg/m(2) on days 1 through 5) and bevacizumab (10 mg/kg intravenously on days 1 and 15) every 28 days (Regimen TB) or nab-paclitaxel (100 mg/m(2) , or 80 mg/m(2) post-addendum 5 secondary to toxicity, on days 1, 8, and 15), bevacizumab (10 mg/kg on days 1 and 15), and carboplatin (area under the curve [AUC] 6 on day 1, or AUC 5 post-addendum 5) every 28 days (Regimen ABC). Accrual goal was 41 patients per regimen. The primary aim of this study was to estimate progression-free survival rate at 6 months (PFS6) in each regimen. A regimen would be considered promising if its PFS6 rate was > 60%. RESULTS: Ninety-three eligible patients (42 TB and 51 ABC) were enrolled. The majority of patients had M1c disease (20 TB and 26 ABC). The median PFS and overall survival times with ABC were 6.7 months and 13.9 months, respectively. Median PFS time and median overall survival with TB were 3.8 months and 12.3 months, respectively. The most common severe toxicities (≥ grade 3) in both regimens were cytopenias, fatigue, and thrombosis. Among the first 41 patients enrolled onto each regimen, PFS6 rate was 32.8% (95% confidence interval: 21.1%-51.2%) for TB and 56.1% (90% confidence interval: 44.7%-70.4%) for ABC. CONCLUSIONS: The addition of bevacizumab to nab-paclitaxel and carboplatin shows promising activity despite tolerability issues.

The Impact of Within-Consultation and Preconsultation Decision Aids for Localized Prostate Cancer on Patient Knowledge: Results of a Patient-Level Randomized Trial.

OBJECTIVE: To evaluate the role of timing (either before or during initial consultation) on the effectiveness of decision aids (DAs) to support shared-decision-making in a minority-enriched sample of patients with localized prostate cancer using a patient-level randomized controlled trial design. METHODS: We conducted a 3-arm, patient-level-randomized trial in urology and radiation oncology practices in Ohio, South Dakota, and Alaska, testing the effect of preconsultation and within-consultation DAs on patient knowledge elements deemed essential to make treatment decisions about localized prostate cancer, all measured immediately following the initial urology consultation using a 12-item Prostate Cancer Treatment Questionnaire (score range 0 [no questions correct] to 1 [all questions correct]), compared to usual care (no DAs). RESULTS: Between 2017 and 2018, 103 patients-including 16 Black/African American and 17 American Indian or Alaska Native men-were enrolled and randomly assigned to receive usual care (n = 33) or usual care and a DA before (n = 37) or during (n = 33) the consultation. After adjusting for baseline characteristics, there were no statistically significant proportional score differences in patient knowledge between the preconsultation DA arm (0.06 knowledge change, 95% CI -0.02 to 0.12, P = .1) or the within-consultation DA arm (0.04 knowledge change, 95% CI -0.03 to 0.11, P = .3) and usual care. CONCLUSION: In this trial oversampling minority men with localized prostate cancer, DAs presented at different times relative to the specialist consultation showed no improvement in patient knowledge above usual care.

Enhancing life after cancer in diverse communities.

BACKGROUND: Although large numbers of cancer survivors exist in every community, including minority communities, there is a significant gap in knowledge about best practices for these patients. METHODS: The Community Networks Program, funded by the National Cancer Institute Center to Reduce Cancer Health Disparities, has developed and tested unique services for these communities. These programs have used community-based participatory research techniques under a framework of diffusion of innovation and communications theory. RESULTS: This article describes some specifically tailored interventions that may be useful to a wide range of providers working with the underserved. CONCLUSIONS: Enhancing life after cancer can be achieved in underserved communities by supplementing local resources.

Shared decision making in cancer screening and treatment decisions for American Indian and Alaska native communities: can we ethically calibrate interventions to patients' values?

Shared decision making has been advocated as a key ethical strategy to improve quality of care and cancer control, especially in relation to screening and treatment decisions at various stages of the cancer continuum. Recent research on cancer in American Indian/Alaska Native (AI/AN) communities has highlighted significant disparities, raising questions about how best to implement prevention and screening programs in often fragmented and underfunded Indian health, tribal and urban systems. Incorporating shared decision making initiatives routinely may provide opportunities to address the complex choices AI/AN patients face.

Health Disparities in Cancer Among American Indians and Alaska Natives.

American Indians and Alaska Natives (AI/AN) are underserved populations who suffer from several health disparities, 1 of which is cancer. Malignancies, especially cancers of the breast, liver, and lung, are common causes of death in this population. Health care disparities in this population include more limited access to diagnostic radiology because of geographic and/or health system limitations. Early detection of these cancers may be enabled by improving patient and physician access to medical imaging. Awareness by the radiology community of the cancer disparities among this population is needed to support research targeted to this specific ethnic group and to support outreach efforts to provide more imaging opportunities. Providing greater access to imaging facilities will also improve patient compliance with screening recommendations, ultimately improving mortality in these populations.

The impact of multi-modal therapy on survival for uterine carcinosarcomas.

OBJECTIVES: To investigate treatment outcomes of patients with carcinosarcoma of the uterus and to identify parameters predictive of survival. Secondary objectives included (a) the assessment of treatment failures as a function of histologic subtypes and (b) the impact of the new FIGO staging classification system. METHODS: This is a retrospective outcomes analysis of 121 patients diagnosed with primary carcinosarcoma of the uterus. Clinical, surgical and pathological data were reviewed and patients were classified according to the new 2009 FIGO staging system for endometrial carcinoma. Survivorship curves were evaluated with the log-rank test and associations between events and variables with Cox proportional hazards model. RESULTS: In the multivariate analyses for disease-specific survival (DSS) and disease-free survival (DFS), the only independent factors were FIGO stage, adjuvant chemotherapy after surgery and the presence of clear cell histology in the tumor. The 5-year DSS for stages I-II, III and IV was 59%, 22% and 9%, respectively. The administration of platin-based chemotherapy provided a significant benefit with regard to both DFS (OR=0.28; p=0.001) and DSS (OR=0.35; p=0.01). While radiotherapy (RT) appeared to control vaginal failures in all stages, pelvic RT did not impact DSS. Of importance, the epithelial component was the predominant histology in both the primary extrauterine metastases (94%) and the distant failure sites (82%). CONCLUSIONS: This highly aggressive uterine malignancy warrants comprehensive surgical staging to assess tumor dissemination followed by systemic therapy in patients with both early and advanced stage disease.

Adaptation, dissemination, and evaluation of a cancer palliative care curriculum for the Indian health system.

In 2006, the Indian Health Service (IHS) and the National Cancer Institute (NCI) collaborated to develop an interdisciplinary palliative training program for health professionals in the Indian health system. Their goal was to improve clinician knowledge and skills in palliative care, to train future trainers, and to increase access to palliative care for American Indians and Alaska Natives. The combined program of participant self-study utilizing a multimedia CD-ROM and train-the-trainer seminars followed the curriculum entitled Education in Palliative and End-of-Life Care for Oncology (EPEC-O) with American Indian and Alaska Native Cultural Considerations. Three seminars trained 89 interdisciplinary health providers from throughout the Indian health system. Evaluations demonstrated increased clinician self-reported knowledge and confidence to train and high satisfaction with training. Forty-two of 67 participants completed an anonymous post-conference Web questionnaire. Nearly half had conducted or definitively planned palliative education sessions, and 57 percent started new palliative services at their practice sites.

Cancer patients and their companion animals: results from a 309-patient survey on pet-related concerns and anxieties during chemotherapy.

The purpose of this study was to explore whether cancer patients, who are actively receiving cancer therapy and who sometimes have only a few months to live, have anxieties or concerns that arise as a result of not being able to care for their pets during their illness or after their demise. A survey was developed and utilized among such patients to assess whether they had pet-related concerns and anxieties and to determine whether they desired more information on available pet-related resources. Three hundred nine patients completed the survey, and 170 (55%) had a pet(s). The majority described that their pets helped them during their cancer. Only 4% of all patients and 7% of the pet owners desired more information on community resources for pet care, and 80% of pet owners had family members who were already helping them with pet care. Cancer patients appear to benefit from their pets and report few pet-related concerns. Healthcare providers at other medical centers should consider determining whether their patients have needs and anxieties related to caring for their pets and whether educational efforts should be put forth to focus on such issues.

Tetrahydrocannabinol and Cannabidiol Use in an Outpatient Palliative Medicine Population.

BACKGROUND: Palliative medicine physicians are challenged by lack of guidance regarding effectiveness and dosing of cannabis products in the setting of their emerging popularity. OBJECTIVE: The aim of this study was to describe early patterns of tetrahydrocannabinol (THC) and cannabidiol (CBD) use in Florida following passage of the state's first medical marijuana law. We describe here the perceived benefits, side effects, and beliefs expressed by patients in a single outpatient academic palliative medicine practice. METHODS: A cross-sectional survey was performed of a sequential convenience sample of patients who presented to an outpatient academic palliative medicine clinic over a 3-month period. RESULTS: In all, 24% (14/58) of respondents reported THC use, with half using THC on a daily basis. Patients reported improvements in pain, appetite, and nausea. In all, 71% (10/14) began using THC after the diagnosis of their chronic illness, and the most common form of usage was vaping. In all, 24% (14/58) of patients reported CBD use. Patients reported improvements in pain, and the most common form of usage was topical application. None of the patients had used CBD prior to the onset of their chronic illness. In all, 21% (3/14) of THC users and 21% (3/14) of CBD users thought that their substance was helping to cure their illness. Individual reported side effects in both groups were minimal. CONCLUSIONS: Approximately a quarter of outpatient palliative care patients use THC or CBD, often on a daily basis. Palliative care providers should be aware of the frequency, diverse usage, and beliefs behind cannabis product use in this patient population.

Patients' Perspectives and Advice on How to Discuss Sexual Orientation, Gender Identity, and Sexual Health in Oncology Clinics.

OBJECTIVE: This study sought to understand the patients' perspective of what contributes to an absence of discussions of sexual orientation (SO), gender identity (GI), and sexual health in cancer care. METHODS: Patients were recruited from oncology, gynecology, and a gender transition clinic to participate in semistructured interviews, which were analyzed with qualitative methods. RESULTS: A total of 25 patients were interviewed, shedding light on 2 themes. The first was that these conversations are important but infrequent. One patient explained, "…. we know people who have had sex changes…[they] would have appreciated that question." In response to whether sexual health was ever brought up, one patient responded, "No doctor ever has." Patients described unaddressed issues: "There have been times, you know, we've wondered if it was okay to make love." The second theme consisted of 4 pragmatic, patient-provided points to facilitate discussions: (1) implementation of a scale of 1 to 10 (with 10 being comfortable) to first gauge patients' comfort in talking about SO, GI, and sexual health; (2) having the health-care provider explore the topic again over-time; (3) making sure the health-care provider is comfortable, as such comfort appears to enhance the patient's comfort ("I have a doctor here, a female doctor, who just matter of fact will ask if I get erections and so on because of the medication she's giving me);" and (4) eliminating euphemisms (one patient stated, "I don't know what you mean by 'sexual health'."). CONCLUSION: Oncology health-care providers have a unique opportunity and responsibility to address SO, GI, and sexual health.

Querying Patients With Cancer About Sexual Health and Sexual and Gender Minority Status: A Qualitative Study of Health-Care Providers.

BACKGROUND: Although national organizations advocate that health-care providers ask patients about sexual health and sexual and gender minority status-to learn, for example, about side effects of treatment and to understand patients' social support-these conversations often do not occur. This study explored health-care providers' reasons for having/not having these conversations. METHODS: This single-institution study recruited health-care providers from medical oncology, hematology, radiation oncology, and gynecology. Face-to-face interviews were recorded, transcribed, and analyzed qualitatively. RESULTS: Three main themes emerged: (1) patient-centric reasons for discussing/not discussing sexual health and sexual and gender minority status ("So I think just the holistic viewpoint is important"); (2) health-care provider-centric reasons for discussing/not discussing these issues ("That's going to take more time to talk about and to deal with…" or "I was raised orthodox, so this is not something we talk about…"; and (3) reasons that appeared to straddle both of the above themes (eg, acknowledgment of the sometimes taboo nature of these topics). CONCLUSION: Although many health-care providers favor talking with patients with cancer about sexual health and sexual and gender minority status, limited time, personal reluctance, and the taboo nature of these topics appear at times to hamper the initiation of these conversations.