Grant Details
| Grant Number: | 5R21CA176551-02 Interpret this number |
| Primary Investigator: | Diefenbach, Michael |
| Organization: | Feinstein Institute For Medical Research |
| Project Title: | Novel Approach to Facilitate Decisions in Patients W Muscle Invasive Bladder CA |
| Fiscal Year: | 2016 |
Abstract
¿ DESCRIPTION (provided by applicant): Radical cystectomy (RC) is standard treatment for patients with muscleinvasive bladder cancer (MIBC). Level I evidence in the form of two randomized clinical trials and a metaanalysis have demonstrated an improvement in survival with the integration of neoadjuvant cisplatinbased combination chemotherapy (NC). Yet, a recent populationbased study demonstrated that only 1.2% of patients receive NC. Barriers to NC uptake are a) a lack of a tool predicting survival benefits with neoadjuvant therapy; and b) lack of evidencebased protocols to communicate complex data about the risks and benefits of such therapy. To address these issues, we have recently developed a model to predict survival in patients with MIBC treated with surgery based on commonly available preoperative variables. While such a model is the first critical step for decision making, there is a paucity o data on what type of information patients need to make a decision, along with how this individualized prognositic information would be best conveyed and integrated into the patientphysician consultation process. Thus, the specific aims are: Specific Aim 1: To develop and refine a counseling protocol consisting of a webbased risk prediction tool and two educational brochures, one for patients and one for physicians. Two focus groups (FG) will provide insights about MIBC survivors' information needs and preferences. 1 FG with physicians will explore barriers to recommending NC. An Internet survey with physicians through the Bladder Cancer Advocacy Network will identify additional barriers. Results will be incorporated in the content and layout of the educational brochures and the risk prediction tool. Usability of the risk prediction tool and content of the brochures will be evaluated by physicians (Urologists (n=5) and medical oncologists (n=5)) and patients (n = 10). Specific Aim 2a): To train urologists and oncologists in the use of the counseling protocol. During a 30min training session, physicians will be introduced in the use of the riskprediction tool and the physician brochure and be educated about appropriate risk communication principles. Aim 2b) To evaluate acceptability and feasibility of the counseling protocol with physicians and MIBC survivors. Newly diagnosed MIBC patients eligible for NC (N = 36), recruited in equal numbers from two study sites (Mount Sinai & Duke University), will participate in the counseling protocol. Pre and postintervention measurements will assess patients' risk perception, satisfaction with patientphysician communication, and decision making variables. The present research has the potential to significantly impact and change clinical practice through the integration of a structured risk communication protocol into the patient physician consultation. It is innovative, a it is the first of its kind to combine an evidencebased risk prediction tool with patient educatin into a physicianpatient counseling protocol for patients with MIBC.
Publications
Examining the impact of a multimedia intervention on decisional conflict and psychological distress among early-stage breast cancer patients: results from a nationwide RCT.
Authors: Marziliano A. , Miller S.M. , Fleisher L.G. , Ropka M.E. , Stanton A.L. , Wen K.Y. , Cornelius T. , Lapitan E. , Diefenbach M.A. .
Source: Translational Behavioral Medicine, 2023-06-28 00:00:00.0; , .
EPub date: 2023-06-28 00:00:00.0.
PMID: 37379519
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Examining the impact of a multimedia intervention on treatment decision-making among newly diagnosed prostate cancer patients: results from a nationwide RCT.
Authors: Diefenbach M.A. , Benedict C. , Miller S.M. , Stanton A.L. , Ropka M.E. , Wen K.Y. , Fleisher L.G. , Mohamed N.E. , Hall S.J. .
Source: Translational Behavioral Medicine, 2018-11-21 00:00:00.0; 8(6), p. 876-886.
PMID: 29982747
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Comparative Effectiveness Of Treatment Strategies For Bladder Cancer With Clinical Evidence Of Regional Lymph Node Involvement
Authors: Galsky M.D. , Stensland K. , Sfakianos J.P. , Mehrazin R. , Diefenbach M. , Mohamed N. , Tsao C.K. , Boffetta P. , Wiklund P. , Oh W.K. , et al. .
Source: Journal Of Clinical Oncology : Official Journal Of The American Society Of Clinical Oncology, 2016-08-01 00:00:00.0; 34(22), p. 2627-35.
PMID: 27269939
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Pulmonary complications with the use of mTOR inhibitors in targeted cancer therapy: a systematic review and meta-analysis.
Authors: Gartrell B.A. , Ying J. , Sivendran S. , Boucher K.M. , Choueiri T.K. , Sonpavde G. , Oh W.K. , Agarwal N. , Galsky M.D. .
Source: Targeted Oncology, 2014 Sep; 9(3), p. 195-204.
PMID: 23852656
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Metabolic complications with the use of mTOR inhibitors for cancer therapy.
Authors: Sivendran S. , Agarwal N. , Gartrell B. , Ying J. , Boucher K.M. , Choueiri T.K. , Sonpavde G. , Oh W.K. , Galsky M.D. .
Source: Cancer Treatment Reviews, 2014 Feb; 40(1), p. 190-6.
PMID: 23684373
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Toxicities following treatment with bisphosphonates and receptor activator of nuclear factor-¿B ligand inhibitors in patients with advanced prostate cancer.
Authors: Gartrell B.A. , Coleman R.E. , Fizazi K. , Miller K. , Saad F. , Sternberg C.N. , Galsky M.D. .
Source: European Urology, 2014 Feb; 65(2), p. 278-86.
PMID: 23706567
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Cytoreductive nephrectomy for metastatic renal cell carcinoma in the era of targeted therapy in the United States: a SEER analysis.
Authors: Tsao C.K. , Small A.C. , Kates M. , Moshier E.L. , Wisnivesky J.P. , Gartrell B.A. , Sonpavde G. , Godbold J.H. , Palese M.A. , Hall S.J. , et al. .
Source: World Journal Of Urology, 2013 Dec; 31(6), p. 1535-9.
PMID: 23223962
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The follicle-stimulating hormone receptor: a novel target in genitourinary malignancies.
Authors: Gartrell B.A. , Tsao C.K. , Galsky M.D. .
Source: Urologic Oncology, 2013 Nov; 31(8), p. 1403-7.
PMID: 22513137
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Trends and variations in utilization of nephron-sparing procedures for stage I kidney cancer in the United States.
Authors: Small A.C. , Tsao C.K. , Moshier E.L. , Gartrell B.A. , Wisnivesky J.P. , Godbold J. , Sonpavde G. , Palese M.A. , Hall S.J. , Oh W.K. , et al. .
Source: World Journal Of Urology, 2013 Oct; 31(5), p. 1211-7.
PMID: 22622394
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Emerging personalized approaches for the management of advanced urothelial carcinoma.
Authors: Tsao C.K. , Gartrell B.A. , Oh W.K. , Galsky M.D. .
Source: Expert Review Of Anticancer Therapy, 2012 Dec; 12(12), p. 1537-43.
PMID: 23253220
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Trends in the use of cytoreductive nephrectomy in the United States.
Authors: Tsao C.K. , Small A.C. , Moshier E.L. , Gartrell B.A. , Wisnivesky J.P. , Sonpavde G. , Godbold J.H. , Palese M.A. , Hall S.J. , Oh W.K. , et al. .
Source: Clinical Genitourinary Cancer, 2012 Sep; 10(3), p. 159-63.
PMID: 22651971
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