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2854 citation(s) found for "Ma, Ann T".

Survival benefit needed to undergo chemotherapy: Patient and physician preferences
Vaz-Luís, Inês , O’Neill, Anne, Sepucha, Karen , Baker, Emily, Dang, Chau T. , Northfelt, Donald W. , Schneider, Bryan P. , Miller, Kathy D. , Winer, Eric P. , Sledge, George W. , Partridge, Ann H.

Cancer | March 22, 2017 | Volume: 123 | Issue: 15 | Pages: 2821-2828

10.1002/cncr.30671 | PMID 28323331 Get It

BACKGROUNDPublished studies have suggested that most patients with early stage breast cancer are willing, for modest survival benefits, to receive 6 months of adjuvant cyclophosphamide, methotrexate, and 5‐fluorouracil, an older regimen that is used infrequently today. We examined preferences regarding the survival benefit needed to justify 6 months of a contemporary chemotherapy regimen.METHODSThe Eastern Cooperative Oncology Group Protocol 5103 was a phase 3 trial that randomized breast cancer patients to receive standard adjuvant doxorubicin, cyclophosphamide, and paclitaxel with either bevacizumab or placebo. Serial surveys to assess quality of life were administered to patients enrolled between January 1, 2010, and June 8, 2010. Survival benefit needed to justify 6 months of chemotherapy by patients was collected at the 18‐month assessment. A parallel survey was sent to physicians who had enrolled patients in the study.RESULTSOf 519 patients who had not withdrawn at a time point earlier than 18 months, 87.8% responded to this survey. A total of 175 physicians participated. We found considerable variation in patient preferences, particularly for modest survival benefits: for 2 months of benefit, 57% would consider 6 months of chemotherapy, whereas 96% of patients would consider 6 months of chemotherapy for 24 months. Race and education were associated with the choices. Physicians who responded were less likely to accept chemotherapy for modest benefit.CONCLUSIONSAmong patients who received contemporary adjuvant chemotherapy in a randomized controlled trial, we found substantial variation in preferences regarding benefits that justified undergoing chemotherapy. Differences between patients' and physicians' choices were also apparent. Eliciting preferences regarding risks and benefits of adjuvant chemotherapy is critical. Cancer 2017;123:2821–28. © 2017 American Cancer Society.
Partners of young breast cancer survivors: A cross-sectional evaluation of psychosocial issues and mental health.
Borstelmann, Nancy A. , Rosenberg, Shoshana M. , Gelber, Shari , Meyer, Meghan E., Ruddy, Kathryn J. , Schapira, Lidia , Come, Steven E. , Maramaldi, Peter , Borges, Virginia F. , Cadet, Tamara , Partridge, Ann H.

Journal of Clinical Oncology | March 21, 2017 | Volume: 35 | Issue: 5_suppl | Pages: 184-184

10.1200/jco.2017.35.5_suppl.184 Get It

184 Background: While evidence of the challenges of cancer caregiving has been growing, scant research addresses the experience of partners of young adults with cancer. These individuals and their relationships may be particularly vulnerable to stress, especially when managing the complexity of cancer care and survivorship with their partner. We sought to evaluate psychosocial concerns and mental health in the partners of young survivors of early stage breast cancer (BC). Methods: We invited partners of young women w/BC diagnosed at age ≤ 40 yrs enrolled in a prospective cohort study to participate in a one-time survey evaluating psychosocial concerns including quality of life, coping, social support, financial insecurity, partnership concerns, parenting concerns, anxiety and depression. Logistic regression was used to explore predictors of anxiety (score > 8 on Hospital Anxiety and Depression Scale (HADS)). Results: Most respondents (284/289) were male, with median age 43 yrs (range 27-65). The median time of survey completion was 62 months (range 16 -114) after their partner’s dx. Respondents were mostly white (93%), working full time (94%), and college educated (78%); 29% reported some financial stress, 74% were parenting children < 18 yrs, and 32% reported at least a fair amount of relationship concern. 42% (106/250) had anxiety (39/289 respondents (13%) had incomplete/missing HADS). In univariable analyses, lower education, working full time, parenting concerns, insufficient social support and maladaptive coping were associated (p < .05) with anxiety. In the multivariable model, only maladaptive coping remained significantly associated with anxiety (p < .01, OR = 2.32 (95% CI: 1.22, 4.39)). Conclusions: Partners of young BC survivors who used less constructive/more maladaptive coping strategies experience negative mental health outcomes after tx has ended. Caregivers’ anxiety may have implications for both their own and survivors’ health and QOL. Future interventions might focus on the development of constructive coping strategies to enhance adjustment and role effectiveness in dealing with the impact of cancer.
Consensus treatment guidelines for urgent symptoms in cholangiocarcinoma (CC) patients (pts) with biliary stents or catheters using the modified RAND/UCLA Delphi process.
Iyer, Renuka , Acquisto, Susan, Choti, Michael A., Hong, Theodore S. , Kis, Béla , Mead, Peter A., Parikh, Neehar D. , Roberts, Lewis R. , Siegel, Richard S., Whisenant, Jonathan, Cherepanov, Dasha , Broder, Michael S. , Bridgewater, John , Roberts, Rebecca J. , Sicklick, Jason Keith , Valle, Juan W. , Roberts, Lewis R , Parikh, Neehar D

Journal of Clinical Oncology | March 21, 2017 | Volume: 35 | Issue: 4_suppl | Pages: 452-452

10.1200/jco.2017.35.4_suppl.452 Get It

452 Background: CC pts with biliary stents or catheters often present with fever and/or jaundice requiring urgent treatment for which there is no uniform guideline. We aimed to develop an expert panel consensus on this topic using the modified RAND/UCLA Delphi process to rate treatment appropriateness. Methods: We recruited 13 physician experts from relevant specialty, geography, and practice settings. Patient scenarios were developed based on a literature review, and therapies were rated by the experts before and after a face-to-face discussion. The appropriateness of various therapies was rated on a 1-9 scale and classified as appropriate, inappropriate, or uncertain. Scenarios with > 2 ratings of 1-3 (inappropriate) and > 2 ratings of 7-9 (appropriate) were considered to have disagreement and were not assigned an appropriateness rating. Results: Panelists were from all US regions (92%) and the UK (8%); had practiced for a mean 16.5 years (4-33 years) and reported seeing an average of 120 unique CC patients a year (0-900 pts). Panelists rated 288 clinical scenarios. Experts decided that ongoing treatment with chemotherapy did not influence decision-making. Disagreement decreased from 37.5% before the meeting to 10.4% after. Consensus statements are summarized in table 1. Conclusions: The Delphi process produced consensus guidelines to fill an unmet need in urgent management of ascending cholangitis in pts with CC. Studies of the impact of these guidelines on cost of care and pt outcomes are warranted. (Support: The Cholangiocarcinoma Foundation)[Table: see text]
Pooled Clustering of High-Grade Serous Ovarian Cancer Gene Expression Leads to Novel Consensus Subtypes Associated with Survival and Surgical Outcomes
Armasu, Sebastian M. , Kalli, Kimberly R., Heinzen, Ethan P. , Keeney, Gary L., Cliby, William A. , Oberg, Ann L. , Goode, Ellen L. , Kaufmann, Scott H. , Wang, Chen , Maurer, Matthew J.

Clinical Cancer Research | March 9, 2017 | Volume: 23 | Issue: 15 | Pages: 4077-4085

10.1158/1078-0432.ccr-17-0246 | PMID 28280090 Get It

Abstract Purpose: Here we assess whether molecular subtyping identifies biological features of tumors that correlate with survival and surgical outcomes of high-grade serous ovarian cancer (HGSOC). Experimental Design: Consensus clustering of pooled mRNA expression data from over 2,000 HGSOC cases was used to define molecular subtypes of HGSOCs. This de novo classification scheme was then applied to 381 Mayo Clinic HGSOC patients with detailed survival and surgical outcome information. Results: Five molecular subtypes of HGSOC were identified. In the pooled dataset, three subtypes were largely concordant with prior studies describing proliferative, mesenchymal, and immunoreactive tumors (concordance &gt; 70%), and the group of tumors previously described as differentiated type was segregated into two new types, one of which (anti-mesenchymal) had downregulation of genes that were typically upregulated in the mesenchymal subtype. Molecular subtypes were significantly associated with overall survival (P &lt; 0.001) and with rate of optimal surgical debulking (≤1 cm, P = 1.9E−4) in the pooled dataset. Among stage III-C or IV Mayo Clinic patients, molecular subtypes were also significantly associated with overall survival (P = 0.001), as well as rate of complete surgical debulking (no residual disease; 16% in mesenchymal tumors compared with &gt;28% in other subtypes; P = 0.02). Conclusions: HGSOC tumors may be categorized into five molecular subtypes that associate with overall survival and the extent of residual disease following debulking surgery. Because mesenchymal tumors may have features that were associated with less favorable surgical outcome, molecular subtyping may have future utility in guiding neoadjuvant treatment decisions for women with HGSOC. Clin Cancer Res; 23(15); 4077–85. ©2017 AACR.
Genetically Predicted Telomere Length is not Associated with Pancreatic Cancer Risk
Antwi, Samuel O. , Bamlet, William R. , Broderick, Brendan T., Chaffee, Kari G. , Oberg, Ann L. , Jatoi, Aminah , Boardman, Lisa A., Petersen, Gloria M. , Rabe, Kari G. , Öberg, Ann, Boardman, Lisa A., Antwi, Samuel O , Bamlet, William R

Cancer Epidemiology, Biomarkers & Prevention | March 6, 2017 | Volume: 26 | Issue: 6 | Pages: 971-974

10.1158/1055-9965.epi-17-0100 | PMID 28264873 Get It

Abstract Background: Epidemiologic associations of leukocyte telomere length (LTL) and pancreatic ductal adenocarcinoma (PDAC) have been inconsistent owing, in part, to variation in telomere length (TL) assessment across studies. To overcome this limitation and address concerns of potential reverse causation, we used carriage of telomere-related alleles to genetically predict TL and examined its association with PDAC. Methods: A case–control study of 1,500 PDAC cases and 1,500 controls, frequency-matched on age and sex was performed. Eight of nine polymorphisms previously associated with variation in LTL were analyzed. Genetic risk scores (GRS) consisting of the TL-related polymorphisms were computed as the number of long TL alleles carried by an individual scaled to published kilobase pairs of TL associated with each allele. Participants were further categorized on the basis of the number of short TL alleles they carry across all eight SNPs. Associations were examined in additive and dominant models using logistic regression to calculate ORs and 95% confidence intervals (CI). Results: In age- and sex-adjusted models, one short TL allele (rs10936599, T) was associated with reduced risk, whereas another short TL allele (rs2736100, A) was associated with increased risk, with per-allele ORs of 0.89 (95% CI, 0.79–0.99) and 1.13 (95% CI, 1.01–1.24), respectively. No association was observed with GRS or short TL allele counts, and no associations were observed in the dominant models. Conclusions: Findings suggest that genetically predicted short TL is not associated with PDAC risk. Impact: Common genetic determinants of short TL do not appear to influence PDAC risk. Cancer Epidemiol Biomarkers Prev; 26(6); 971–4. ©2017 AACR.
Abstract B25: The critical importance of the blood-brain barrier in modulating the response to otherwise highly effective targeted therapies in patient-derived orthotopic glioblastoma xenografts
Calligaris, David, Parrish, Karen E. , Laramy, Janice K., Kim, Minjee , Carlson, Brett L. , Johnson, Aaron J. , Elmquist, William F. , Sarkaria, Jann N. , Daniel, J. , Mladek, Ann C. , Zhang, Shuangling , Schroeder, Mark A. , Bakken, Katrina K. , Johnson, Aaron J. , Agar, Nathalie Y.R.

Clinical Cancer Research | March 1, 2017 | Volume: 22 | Issue: 16_Supplement | Pages: B25-B25

10.1158/1557-3265.pdx16-b25 Get It

Abstract Clinical data indicate that certain regions within glioblastoma (GBM) have a relatively intact blood-brain barrier (BBB), but controversy surrounds whether associated heterogeneous delivery may limit efficacy for otherwise highly active drugs with poor brain distribution. In this study, the efficacy of molecularly targeted therapies was compared in relevant GBM patient-derived xenograft (PDX) models grown either as heterotopic or orthotopic tumors. The impact of further disrupting BBB integrity in non-responsive orthotopic tumors was evaluated by over-expressing vascular endothelial growth factor (VEGF) and measuring drug distribution by matrix-assisted laser desorption ionization mass spectrometry imaging (MALDI-MSI). The brain:plasma ratio for five targeted agents was determined by LC-MSMS and treatment efficacy was evaluated in target-relevant GBM PDX lines: erlotinib (brain:plasma = 0.02 ± 0.02; efficacy tested in GBM6), palbociclib (brain:plasma = 0.06; efficacy tested in GBM22), AZD1775 (brain:plasma = 0.05; efficacy tested in GBM22), SAR405838 (brain:plasma = 0.01 ± 0.003; efficacy tested in GBM108), and AZD4547 (brain:plasma = 0.045 ± 0.02; efficacy tested in GBM150). Each of these drugs was effective in relevant GBM PDX flank tumor models with a 27% to 218% prolongation in the median time to exceed their pre-specified endpoint compared to placebo treatment (p≤0.02 for each drug). In contrast, none of these drugs were effective in prolonging survival in the same target-relevant orthotopic tumor models (-6% to 8% extension in median survival; p&gt;0.05 for each drug). Consistent with partial and heterogeneous disruption of the BBB, MALDI-MSI of erlotinib, AZD1775 or SAR405838 distribution within orthotopic tumors demonstrated highly heterogeneous drug levels with large regions within each tumor approaching the low drug levels observed within surrounding normal brain. To further evaluate whether heterogenous drug distribution in orthotopic tumors could account for poor treatment efficacy, GBM108 was transduced with lentiviral constructs encoding for VEGF or empty vector (EV). While both GBM108-sublines were readily detectable with gadolinium-enhanced magnetic resonance imaging (MRI), the GBM108-VEGF tumors had a significantly more disrupted BBB, as evidenced by a more uniform and intense distribution of a brain-impenetrant TexasRed-dextran vascular marker. Similarly, the distribution of SAR405838, measured by MALDI-MSI, was markedly higher and more uniform in the GBM108-VEGF tumors when compared to the GBM108-EV tumors. Enhanced delivery of SAR405838 into orthotopic GBM108-VEGF models translated into a marked enhancement in treatment efficacy in comparison to GBM108-EV with a median survival prolongation of 37 vs. 4 days, respectively (p=0.0055). Collectively, these data highlight the importance of testing novel therapeutic agents in orthotopic tumor models and suggest that limited brain penetration for many molecules may significantly limit their efficacy in brain tumors that have a partially intact BBB. In the face of continued failure to develop effective targeted agents for GBM, these in vivo results highlight the importance of re-evaluating the dogma in neuro-oncology that the BBB is fully disrupted in GBM and, therefore, drug delivery across the BBB is not a major factor limiting treatment efficacy. Citation Format: Jann N. Sarkaria, David Calligaris, Daniel Ma, Karen Parrish, Ann C. Mladek, Janice Laramy, Minjee Kim, Shuangling Zhang, Mark Schroeder, Brett L. Carlson, Katrina Bakken, Aaron Johnson, Nathalie Agar, William Elmquist. The critical importance of the blood-brain barrier in modulating the response to otherwise highly effective targeted therapies in patient-derived orthotopic glioblastoma xenografts. [abstract]. In: Proceedings of the AACR Special Conference: Patient-Derived Cancer Models: Present and Future Applications from Basic Science to the Clinic; Feb 11-14, 2016; New Orleans, LA. Philadelphia (PA): AACR; Clin Cancer Res 2016;22(16_Suppl):Abstract nr B25.
Abstract P6-11-04: The evaluation of ganitumab/metformin plus standard neoadjuvant therapy in high-risk breast cancer: Results from the I-SPY 2 trial
Veer, Laura van’t, Sanil, Ashish, Yau, C, Forero, Andres , Chien, AJ, Wallace, AM, Moulder, SL, Albain, KS, Kaplan, HG, Elias, AD, Haley, BB, Boughey, JC , Kemmer, KA, Korde, LA, Minton, S., Lang, J. , Buxton, MB, Hylton, NM, Symmans, WF, Lyandres, Julia, Perlmutter, Jane , Esserman, LJ, Berry, DA, Yee, Douglas , Paoloni, Marco , Isaacs, Claudine , Nanda, R, DeMichele, Angela , Hogarth, Michael A. , Berry, Donald A.

Cancer Research | March 1, 2017 | Volume: 77 | Issue: 4_Supplement | Pages: P6-11-04-P6-11-04

10.1158/1538-7445.sabcs16-p6-11-04 Get It

Abstract Background: I-SPY 2 is a multicenter, phase 2 trial using response-adaptive randomization within biomarker subtypes to evaluate novel agents when added to standard neoadjuvant therapy for women with high-risk stage II/III breast cancer - investigational agent(I) +paclitaxel(T) qwk, doxorubicin & cyclophosphamide(AC) q2-3 wk x 4 vs. T/AC (control arm). The primary endpoint is pathologic complete response (pCR) at surgery. The goal is to identify/graduate regimens that have ≥85% Bayesian predictive probability of success (statistical significance) in a 300-patient phase 3 neoadjuvant trial defined by hormone-receptor (HR) & HER2 status & MammaPrint (MP). Regimens may also leave the trial for futility (&lt; 10% probability of success) or following accrual of maximum sample size (10%&lt; probability of success &lt;85%). We report the results for experimental arm Ganitumab, a type I insulin-like growth factor receptor (IGF1R) inhibitor. IGF1R inhibitors are known to induce insulin resistance and all patients assigned to Ganitumab received metformin. Methods: Women with tumors ≥2.5cm were eligible for screening. MP low/HR+ and HER2+ tumors were ineligible for randomization. Hemoglobin A1C≥ 8.0% were ineligible. MRI scans (baseline, 3 cycles after start of therapy, at completion of weekly T and prior to surgery) were used in a longitudinal statistical model to improve the efficiency of adaptive randomization. Ganitumab was given at 12mg/kg q2 weeks and metformin at 850mg PO BID, while receiving ganitumab. Analysis was intention to treat with patients who switched to non-protocol therapy counted as non-pCRs. Ganitumab/metformin was open only to HER2- patients, and eligible for graduation in 3 of 10 pre-defined signatures: HER2-, HR+HER2- and HR-HER2-. Results: Ganitumab/metformin did not meet the criteria for graduation in the 3 signatures tested. When the maximum sample size was reached, accrual to this arm stopped. Ganitumab/metformin was assigned to 106 patients; there were 128 controls. We report probabilities of superiority for Ganitumab/metformin over control and Bayesian predictive probabilities of success in a neoadjuvant phase 3 trial equally randomized between Ganitumab/metformin and control, for each of the 3 biomarker signatures, using the final pathological response data from all patients. Safety data will be presented. SignatureEstimated pCR Rate (95% probability interval)Probability Ganitumab/ Metformin Is Superior to ControlPredictive Probability of Success in Phase 3 Ganitumab/ Metformin N = 106Control N = 128 All HER2-22% (13%-31%)16% (10%-23%)89%33%HR+/HER2-14% (4%-24%)12% (4%-19%)66%21%HR-/HER2-32% (17%-46%)21% (11%-32%)91%51% Conclusion: The I-SPY 2 adaptive randomization study estimates the probability that investigational regimens will be successful in a phase 3 neoadjuvant trial. The value of I-SPY 2 is to give insight about the performance of an investigational agent's likelihood of achieving pCR. For Ganitumab/metformin, no subtype came close to the efficacy threshold of 85% likelihood of success in phase 3, and this regimen does not appear to impact upfront reduction of tumor burden. Our data do not support its continued development for the neoadjuvant treatment of breast cancer. Citation Format: Yee D, Paoloni M, van't Veer L, Sanil A, Yau C, Forero A, Chien AJ, Wallace AM, Moulder S, Albain KS, Kaplan HG, Elias AD, Haley BB, Boughey JC, Kemmer KA, Korde LA, Isaacs C, Minton S, Nanda R, DeMichele A, Lang JE, Buxton MB, Hylton NM, Symmans WF, Lyandres J, Hogarth M, Perlmutter J, Esserman LJ, Berry DA. The evaluation of ganitumab/metformin plus standard neoadjuvant therapy in high-risk breast cancer: Results from the I-SPY 2 trial [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-11-04.
Abstract P6-11-02: Efficacy of Hsp90 inhibitor ganetespib plus standard neoadjuvant therapy in high-risk breast cancer: Results from the I-SPY 2 trial
Forero, Andres , Buxton, MB, Symmans, WF, Chien, AJ, Boughey, JC , Elias, AD, Moulder, SL, Minton, S., Kaplan, HG, Albain, KS, Wallace, AM, Haley, BB, Korde, LA, Nanda, Rita , Lang, JE , Kemmer, KA, Hylton, NM, Veer, Laura van’t, Lyandres, Julia, Perlmutter, Jane , Sanil, Ashish, Berry, DA, Esserman, LJ, Yee, Douglas , DeMichele, Angela , Isaacs, Claudine , Paoloni, Marco , Hogarth, Michael A. , Yau, Christina

Cancer Research | March 1, 2017 | Volume: 77 | Issue: 4_Supplement | Pages: P6-11-02-P6-11-02

10.1158/1538-7445.sabcs16-p6-11-02 Get It

Abstract Background:Pathologic complete response(pCR) after neoadjuvant therapy is an established prognostic biomarker for high-risk breast cancer(BC). Improving pCR rates may identify new therapies that improve survival. I-SPY 2 uses response-adaptive randomization within biomarker subtypes to evaluate novel agents when added to standard neoadjuvant therapy for women with high-risk stage II/III breast cancer; the goal is to identify regimens that have ≥85% Bayesian predictive probability of success (statistical significance) in a 300-patient phase 3 neoadjuvant trial defined by hormone-receptor (HR), HER2 status and MammaPrint (MP). We report the results for Ganetespib, a selective inhibitor of Hsp90 that induces the degradation/deactivation of key drivers of tumor initiation, progression, angiogenesis, and metastasis.Ganetespib + taxanes previously have resulted in a superior therapeutic response compared to monotherapy in multiple solid tumor models including BC. Methods:Women with tumors ≥2.5cm were eligible for screening and participation. MP low/HR+ tumors were ineligible for randomization. QTcF &gt;470msec and HbA1C &gt;8.0% were ineligible. MRI scans (baseline, +3 cycles, following weekly paclitaxel, T, and pre-surgery) were used in a longitudinal statistical model to improve the efficiency of adaptive randomization. Ganetespib was given with weekly T at 150 mg/m2 IV weekly (3 weeks on, 1 off). Patients were premedicated (dexamethasone 10mg and diphenhydramine HCl 25-50 mg, or therapeutic equivalents). Analysis was intention to treat with patients who switched to non-protocol therapy counted as non-pCRs. The Ganetespib regimen was open only to HER2- patients, and eligible for graduation in 3 of 10 pre-defined signatures: HER2-, HR+/HER2- and HR-/HER2-. Results:Ganetespib did not meet the criteria for graduation in the 3 signatures tested. When the maximum sample size was reached, accrual stopped. Ganetespib was assigned to 93 patients; there were 140 controls. We report probabilities of superiority for Ganetespib over control and Bayesian predictive probabilities of success in a neoadjuvant phase 3 trial equally randomized between Ganetespib and control, for the 3 biomarker signatures, using the final pCR data from all patients. Safety data will be presented. SignatureEstimated pCR Rate (95% probability interval)Probability Ganetespib Is Superior to ControlPredictive Probability of Ganetespib Success in a Phase 3 Trial Ganetespib N = 93Control N = 140 All HER2-26% (16%-37%)18% (8%-28%)91%47%HR+/HER2-15% (4%-27%)14% (4%-24%)60%19%HR-/HER2-38% (23%-53%)22% (9%-35%)96%72% Conclusion:The I-SPY 2 adaptive randomization model efficiently evaluates investigational agents in the setting of neoadjuvant BC. The value of I-SPY 2 is that it provides insight as to the regimen's likelihood of success in a phase 3 neoadjuvant study. Although no signature reached the efficacy threshold of 85% likelihood of success in phase 3, we observed the most impact in HR-/HER2- patients, with a 16% improvement in pCR rate. While our data do not support the continued development of Ganetespib alone for neoadjuvant BC, combinations with Ganetespib, which could potentiate its effect, may be worth pursuing in I-SPY 2 or similar trials. Citation Format: Forero A, Yee D, Buxton MB, Symmans WF, Chien AJ, Boughey JC, Elias AD, DeMichele A, Moulder S, Minton S, Kaplan HG, Albain KS, Wallace AM, Haley BB, Isaacs C, Korde LA, Nanda R, Lang JE, Kemmer KA, Hylton NM, Paoloni M, van't Veer L, Lyandres J, Perlmutter J, Hogarth M, Yau C, Sanil A, Berry DA, Esserman LJ. Efficacy of Hsp90 inhibitor ganetespib plus standard neoadjuvant therapy in high-risk breast cancer: Results from the I-SPY 2 trial [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-11-02.
Abstract B83: Elements of theoretical models of health behavior: Planning for breast cancer screening interventions in an American Indian tribe
Petersen, Wesley O., Nicometo, Ann M., Sabaque, Corinna, Vierkant, Robert A.

Cancer Epidemiology, Biomarkers & Prevention | March 1, 2017 | Volume: 26 | Issue: 2_Supplement | Pages: B83-B83

10.1158/1538-7755.disp16-b83 Get It

Abstract Purpose: To identify within demographic features and theoretical models of health behavior, the variables demonstrating differences in the behaviors, beliefs, attitudes, associations, and capacities of sporadic (non-adherent) and persistent (adherent) mammographic screeners for the purpose of guiding future interventions to improve mammographic screening adherence. Procedures: A survey was designed and mailed to all screening-age women of one Bemidji Area tribe. The survey incorporated demographic questions, and questions designed to inform about salient features of respondents' health literacy, social networks, social support, social norms, planned behavior, and health beliefs. Prior to mailing, each survey was assigned a unique identifier and sealed in an envelope. Surveys were mailed to 1,554 women in manner that ensured anonymity of the women's responses and no potential for investigators to discern women's identity via their mailing addresses or other information. Self-report data from returned surveys was used to determine women's mammographic screening status as adherent with local screening guidelines (annual mammogram beginning at age 40 for women at average risk) or non-adherent. Responses for all demographic and theoretical models of health behavior were appropriately categorized and analyzed utilizing global tests of hypotheses. Inherent multicollinearity issues required a two-step process of factor analysis followed by a multivariate analysis of variance. Where themes (e.g., demographics, health literacy, etc.) and factors within themes were significant, a univariate analysis was conducted to ascertain specific questions and responses that significantly differentiated the non-adherent from adherent screeners. Summary of data: We found no significant differences in non-adherent and adherent screeners' responses to questions related to social networks or social norms. We did find that responses from these two groups did differ on demographic features as well as on aspects of health literacy, social support, planned behavior and health beliefs. o Demographic differences involved biopsy histories and employment status. o Differentiating health literacy variables involved recognition of certain terms (e.g., annual) and understanding concepts such as ultrasound and biopsy. o Social support variables that distinguished non-adherent from adherent screeners involved sources of information support, characteristics of providers of emotional support, and sources of emotional support (e.g., solitary or communal). o Planned behavior variables illuminating differences between the screening groups involved (in additions to self-reported screening behaviors): attitudes toward the behavior of obtaining mammograms, intentions to engage in screening, and control beliefs. o Health Beliefs variables distinguishing the two sets of screeners comprised responses to questions about perceived barriers, self-efficacy, and cues to action. Conclusions: Study findings point to opportunities for tribal health and Indian Health Service (IHS) providers and staff to intervene in two broad areas. 1. Some findings associated with social support, planned behavior, and health beliefs can be used to design patient intake forms to alert tribal health and IHS providers to current and potentially non-adherent. 2. Using this information, providers can design interventions to move non-adherent and potentially non-adherent women toward persistent mammographic screening participation. An intervention study will be funded by the Minnesota Department of Health through its Eliminating Health Disparities Initiative. Citation Format: Wesley O. Petersen, Ann M. Nicometo, Robert A. Vierkant, Corinna Sabaque. Elements of theoretical models of health behavior: Planning for breast cancer screening interventions in an American Indian tribe. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr B83.
Abstract A11: Development and beta testing of a culturally appropriate research literacy support tool to increase research participation among minority and underrepresented populations
Riva, Erika , Haring, Rodney C. , González, Evelyn , Katz, Mira L. , Clark, Nikia , Henry, Whitney Ann E., Ortiz, Rosa, Zimmermann, Barret J., Kaur, Judith S. , Rodriguez, Elisa M. , Clayman, Marla L. , Erwin, Deborah O. , Simon, Melissa Andrea

Cancer Epidemiology, Biomarkers & Prevention | March 1, 2017 | Volume: 26 | Issue: 2_Supplement | Pages: A11-A11

10.1158/1538-7755.disp16-a11 Get It

Abstract Background: It is documented that inequities in research participation by minority and underrepresented populations limits the progression of personalized medicine for cancer treatment for these groups. A lack of understanding essential information during the consent process and poor physician-patient communication have been noted as two overarching barriers to patients participating in translational, clinical and biospecimen research. To address these major patient barriers, we developed a plain language research literacy support (RLS) tool to improve the consent process and facilitate dialogue between physicians/research staff and patients. We describe the tool's iterative development process and testing of the developed culturally appropriate RLS tool. Methods: We tested the tool among: 1) patient participants ≥18 years of age, who were able to read and speak English from communities associated with five academic centers in the Midwest and Northeast United States; and 2) eligible recruiters who were employed at an academic center and actively recruiting patients into research. The development process for the RLS tool consisted of two phases: cognitive and beta testing. During cognitive testing, we solicited feedback from patient and recruiter participants about the content and format of the tool including low literacy language, pictures and recommendations for additional content. The tool consisted of concept cards to provide information to assist patients in making an informed decision about participating in research. During beta testing, a condensed version of the tool was tested to assess acceptability and change in knowledge about research participation. Results: Participants included 155 patients (52: cognitive testing phase; 103: beta testing phase) and 20 recruiter participants. Patient participants were mostly females (71%). Self-identified race of patients included: Whites (43%), African Americans (32%), Native Americans (20%), and other (6%). In addition, 23% of patient participants self-identified as Hispanic. During the cognitive testing phase, patient participants reported that the information was clearly laid out and the tool explained the different steps in the recruitment and enrollment process. Patient participants indicated they had learned new information related to randomization, standard of care, coded-information, and biobanking. Although some patient participants acknowledged the cards contained a great deal of information, most reported that the information was essential. Several participants suggested cards be tailored for the Native American population. Recruiters indicated that the cards provided useful information and would assist patients and research staff. During beta testing phase, 98% of participants agreed the information on the cards helped them understand clinical research. After reviewing the cards, 49% of patient participants reported that they would be very likely to participate in research and 32% reported being somewhat likely to participate in research. The majority (61%) of participants indicated that if invited to participate in a research study, they would prefer that the cards would be mailed to them in advance while 34% wanted to review the cards at their medical appointment. Half of the participants preferred accessing the cards on a computer if administered in a video format. Conclusion: The RLS tool was well received among patient and recruiter participants, making it a potentially valuable resource for enrollment of minority and underrepresented patients into health research. The next step will be to test the RLS tool for effectiveness in a randomized controlled trial. Citation Format: Erika E. de la Riva, Rodney Haring, Elisa M. Rodriguez, Evelyn Gonzalez, Mira Katz, Nikia Clark, Whitney Ann E. Henry, Rosa O. Ortiz, Barret J. Zimmermann, Marla L. Clayman, Deborah O. Erwin, Judith S. Kaur, Melissa A. Simon. Development and beta testing of a culturally appropriate research literacy support tool to increase research participation among minority and underrepresented populations. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr A11.