Patient Advocates in Research

Danville, United States

Patient Advocates in Research

Danville, United States
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Cottler L.B.,University of Florida | McCloskey D.J.,U.S. National Institutes of Health | Aguilar-Gaxiola S.,University of California at Davis | Bennett N.M.,University of Rochester | And 8 more authors.
American Journal of Public Health | Year: 2013

Objectives. We used results generated from the first study of the National Institutes of Health Sentinel Network to understand health concerns and perceptions of research among underrepresented groups such as women, the elderly, racial/ethnic groups, and rural populations. Methods. Investigators at 5 Sentinel Network sites and 2 community-focused national organizations developed a common assessment tool used by community health workers to assess research perceptions, health concerns, and conditions. Results. Among 5979 individuals assessed, the top 5 health concerns were hypertension, diabetes, cancer, weight, and heart problems; hypertension was the most common self-reported condition. Levels of interest in research participation ranged from 70.1% among those in the "other" racial/ethnic category to 91.0% among African Americans. Overall, African Americans were more likely than members of other racial/ethnic groups to be interested in studies requiring blood samples (82.6%), genetic samples (76.9%), or medical records (77.2%); staying overnight in a hospital (70.5%); and use of medical equipment (75.4%). Conclusions. Top health concerns were consistent across geographic areas. African Americans reported more willingness to participate in research even if it required blood samples or genetic testing.


Wilson M.K.,University of Toronto | Collyar D.,Patient Advocates In Research | Chingos D.T.,The Noreen Fraser Foundation | Friedlander M.,University of New South Wales | And 7 more authors.
The Lancet Oncology | Year: 2015

Cancer is not one disease. Outcomes and endpoints in trials should incorporate the therapeutic modality and cancer type because these factors affect clinician and patient expectations. In this Review, we discuss how to: define the importance of endpoints; make endpoints understandable to patients; improve the use of patient-reported outcomes; advance endpoints to parallel changes in trial design and therapeutic interventions; and integrate these improvements into trials and practice. Endpoints need to reflect benefit to patients, and show that changes in tumour size either in absolute terms (response and progression) or relative to control (progression) are clinically relevant. Improvements in trial design should be accompanied by improvements in available endpoints. Stakeholders need to come together to determine the best approach for research that ensures accountability and optimises the use of available resources. © 2015 Elsevier Ltd.


Bellavance E.,University of Maryland, Baltimore | Peppercorn J.,Massachusetts General Hospital | Kronsberg S.,University of Maryland, Baltimore | Greenup R.,Duke University | And 7 more authors.
Annals of Surgical Oncology | Year: 2016

Background: Contralateral prophylactic mastectomy (CPM) is commonly performed for the treatment of breast cancer, despite its limited oncologic benefit. Little is known about surgeons’ perceptions of performing CPM. We hypothesized that a proportion of surgeons would report discomfort with performing CPM, particularly when there is discordance between patients’ perceived benefit from CPM and the expected oncologic benefit. Methods: A survey was sent to members of the American Society of Breast Surgeons seeking self-reports of surgeons’ practice patterns, perceptions, and comfort levels with CPM. Results: Of the 2436 members surveyed, 601 responded (response rate = 24.7 %). The median age of respondents was 52 years, and 59 % of responders were women. The majority (58 %) reported that 80 % of their practice was devoted to the treatment of breast disease. Fifty-seven percent (n = 326) of respondents reported discomfort with performing CPM at some point in their practice. While most surgeons (95 %) were comfortable with CPM on a patient with a deleterious BRCA mutation, only 34 % were comfortable performing CPM on an average-risk patient. The most common reasons reported for surgeon discomfort with CPM were a concern for overtreatment, an unfavorable risk/benefit ratio, and inadequate patient understanding of the anticipated risks and benefits of CPM. Conclusions: Despite the increasing use of CPM for the treatment of breast cancer, many surgeons report discomfort with CPM. Concerns with performing CPM predominantly focus on ambiguities surrounding the oncologic benefit and relative risk of this procedure. Further research is needed to define optimal shared decision-making practices in this area. © 2016 Society of Surgical Oncology


PubMed | Saint Louis University, University of Chicago, Patient Advocates in Research, NorthShore University HealthSystem and 4 more.
Type: Journal Article | Journal: Annals of surgical oncology | Year: 2016

Contralateral prophylactic mastectomy (CPM) is commonly performed for the treatment of breast cancer, despite its limited oncologic benefit. Little is known about surgeons perceptions of performing CPM. We hypothesized that a proportion of surgeons would report discomfort with performing CPM, particularly when there is discordance between patients perceived benefit from CPM and the expected oncologic benefit.A survey was sent to members of the American Society of Breast Surgeons seeking self-reports of surgeons practice patterns, perceptions, and comfort levels with CPM.Of the 2436 members surveyed, 601 responded (response rate=24.7%). The median age of respondents was 52years, and 59% of responders were women. The majority (58%) reported that 80% of their practice was devoted to the treatment of breast disease. Fifty-seven percent (n=326) of respondents reported discomfort with performing CPM at some point in their practice. While most surgeons (95%) were comfortable with CPM on a patient with a deleterious BRCA mutation, only 34% were comfortable performing CPM on an average-risk patient. The most common reasons reported for surgeon discomfort with CPM were a concern for overtreatment, an unfavorable risk/benefit ratio, and inadequate patient understanding of the anticipated risks and benefits of CPM.Despite the increasing use of CPM for the treatment of breast cancer, many surgeons report discomfort with CPM. Concerns with performing CPM predominantly focus on ambiguities surrounding the oncologic benefit and relative risk of this procedure. Further research is needed to define optimal shared decision-making practices in this area.


Peppercorn J.,Duke University | Shapira I.,Hofstra University | Deshields T.,Barnes Jewish Hospital | Kroetz D.,University of California at San Francisco | And 6 more authors.
Cancer | Year: 2012

BACKGROUND: The rapid pace of genetics research, coupled with evolving standards for informed consent, can create ethical challenges regarding future use of tissue or information from completed clinical trials. The Cancer and Leukemia Group B (CALGB) Oncology Cooperative Group was faced with an ethical dilemma regarding sharing genetic data from a completed genome-wide association study (GWAS) that was conducted as part of a large, multicenter breast cancer clinical trial with a national database: the Database of Genotypes and Phenotypes National Center for Biotechnology Information (dbGaP). METHODS: The CALGB Ethics Committee conducted a series of multidisciplinary meetings and teleconferences involving patient advocates, bioethicists, clinical researchers, and clinical oncologists to evaluate the ethical issues raised by this case and to identify lessons for improving informed consent to future genetics research in oncology trials. RESULTS: The Ethics Committee recommended that GWAS data be provided to dbGaP consistent with documented consent for future use of tissue among trial participants. Ethical issues, including adequacy of informed consent to future research, limitations of privacy in modern genetics research, the potential impact of population-based genetics research on health disparities, and recontact of research participants for clinical care or further research, were identified as major ethical considerations in this area. CONCLUSIONS: Although modern standards for informed consent should not prohibit research or sharing of data consistent with participant's intent and the public interest, there is an urgent need for national consensus on the appropriate use of archived tissue and standardized informed consent for future research among cancer clinical trial participants. Copyright © 2012 American Cancer Society.


Paller C.J.,Johns Hopkins Hospital | Bradbury P.A.,Queen's University | Ivy S.P.,U.S. National Cancer Institute | Seymour L.,Queen's University | And 12 more authors.
Clinical Cancer Research | Year: 2014

Anticancer drugs are combined in an effort to treat a heterogeneous tumor or to maximize the pharmacodynamic effect. The development of combination regimens, while desirable, poses unique challenges. These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistic and regulatory challenges. The phase I trial is often the initial step in the clinical evaluation of a combination regimen. In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute Investigational Drug Steering Committee developed a set of recommendations for the phase I development of a combination regimen. The first two recommendations focus on the scientific rationale and development plans for the combination regimen; subsequent recommendations encompass clinical design aspects. The CTD Task Force recommends that selection of the proposed regimens be based on a biologic or pharmacologic rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. The design of the phase I clinical trial should take into consideration the potential pharmacokinetic and pharmacodynamic interactions as well as overlapping toxicity. Depending on the specific hypothesized interaction, the primary endpoint may be dose optimization, pharmacokinetics, and/or pharmacodynamics (i.e., biomarker). ©2014 American Association for Cancer Research.


Sikov W.M.,The Miriam Hospital | Berry D.A.,University of Houston | Perou C.M.,The Miriam Hospital | Singh B.,New York University | And 13 more authors.
Journal of Clinical Oncology | Year: 2015

Purpose: One third of patients with triple-negative breast cancer (TNBC) achieve pathologic complete response (pCR) with standard neoadjuvant chemotherapy (NACT). CALGB 40603 (Alliance), a 2 × 2 factorial, open-label, randomized phase II trial, evaluated the impact of adding carboplatin and/or bevacizumab. Patients and Methods: Patients (N = 443) with stage II to III TNBC received paclitaxel 80 mg/m2 once per week (wP) for 12 weeks, followed by doxorubicin plus cyclophosphamide once every 2 weeks (ddAC) for four cycles, and were randomly assigned to concurrent carboplatin (area under curve 6) once every 3 weeks for four cycles and/or bevacizumab 10 mg/kg once every 2 weeks for nine cycles. Effects of adding these agents on pCR breast (ypT0/is), pCR breast/axilla (ypT0/isN0), treatment delivery, and toxicities were analyzed. Results: Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses, dose modification, or early discontinuation resulting from toxicity. Grade ≥ 3 neutropenia and thrombocytopenia were more common with carboplatin, as were hypertension, infection, thromboembolic events, bleeding, and postoperative complications with bevacizumab. Employing one-sided P values, addition of either carboplatin (60% v 44%; P =.0018) or bevacizumab (59% v 48%; P =.0089) significantly increased pCR breast, whereas only carboplatin (54% v41%; P =.0029) significantly raised pCR breast/axilla. More-than-additive interactions between the two agents could not be demonstrated. Conclusion: In stage II to III TNBC, addition of either carboplatin or bevacizumab to NACT increased pCR rates, but whether this will improve relapse-free or overall survival is unknown. Given results from recently reported adjuvant trials, further investigation of bevacizumab in this setting is unlikely, but the role of carboplatin could be evaluated in definitive studies, ideally limited to biologically defined patient subsets most likely to benefit from this agent. © 2014 by American Society of Clinical Oncology.


Katz M.L.,Ohio State University | Archer L.E.,Duke University | Peppercorn J.M.,Duke University | Kereakoglow S.,Dana-Farber Cancer Institute | And 4 more authors.
Cancer | Year: 2012

BACKGROUND: Patient advocates are increasingly involved in cooperative group trials, single-institution cancer programs, and peer-review of research applications. The purpose of this study was to evaluate the role and value of patient advocates from the perspective of Cancer and Leukemia Group B (CALGB) advocates and investigators. METHODS: An online survey was sent to current and past (within 5 years) patient advocates and investigators. RESULTS. Response rates were 72.7% (16 of 22) for advocates and 56.4% (102 of 181) for investigators. Patient advocates were more likely than investigators to report the following: the clinical trial process benefited from advocate involvement on committees (100% of advocates vs 72.1% of investigators; P <.05), advocates contribute to protocol development (92.8% vs 33.8%, respectively; P <.001), the cultural appropriateness of protocols (21.4% vs 10.4%, respectively; P <.05), advocates assist with patient accrual (78.6% vs 23.4%, respectively; P <.001), and advocates add value to concept development and protocol review (100% vs 63.2%, respectively; P <.001). Over half of advocates and investigators reported gaps in patient advocate knowledge and suggested that additional clinical trials training was needed. To improve clinical trials, advocates suggested their earlier involvement in protocol development and increased support from investigators. CALGB investigators recommended improving patient advocate selection and communication skills training: CONCLUSIONS: The majority of patient advocates and investigators perceived benefits from advocate involvement in the clinical trials process; patient advocates placed more value on their role than investigators. The current results indicated that strategies to improve advocacy training and advocate-investigator communication may further enhance the role of patient advocates, and future studies that clarify the role of advocates in the prioritization and development of protocol, consent, and education materials, and on patient accrual, are warranted. © 2012 American Cancer Society.


PubMed | University of Michigan, University of Houston, University of Chicago, National Cancer Institute and 7 more.
Type: Journal Article | Journal: Clinical cancer research : an official journal of the American Association for Cancer Research | Year: 2014

Anticancer drugs are combined in an effort to treat a heterogeneous tumor or to maximize the pharmacodynamic effect. The development of combination regimens, while desirable, poses unique challenges. These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistic and regulatory challenges. The phase I trial is often the initial step in the clinical evaluation of a combination regimen. In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute Investigational Drug Steering Committee developed a set of recommendations for the phase I development of a combination regimen. The first two recommendations focus on the scientific rationale and development plans for the combination regimen; subsequent recommendations encompass clinical design aspects. The CTD Task Force recommends that selection of the proposed regimens be based on a biologic or pharmacologic rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. The design of the phase I clinical trial should take into consideration the potential pharmacokinetic and pharmacodynamic interactions as well as overlapping toxicity. Depending on the specific hypothesized interaction, the primary endpoint may be dose optimization, pharmacokinetics, and/or pharmacodynamics (i.e., biomarker).


PubMed | Patient Advocates in Research
Type: Journal Article | Journal: Journal of oncology practice | Year: 2010

Translating research on genomic changes into novel interventions for patients with cancer requires increased analysis of biospecimens and biomarkers in cancer clinical trials, which involve certain procedural requirements.

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