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Identifying VA Cancer Patients for Clinical Trials: Use of an Umbrella Pre-Screening Protocol to Improve Enrollment in Oncology/Hematology Clinical Trials Within the VA Healthcare System
Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.
Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.
Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.
Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.
Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.
Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.
Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.
Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.
Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.
Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.
Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.
Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.
A Multidisciplinary, Multicenter Partnership Model for Breast Health Care in Women Veterans
Purpose: To demonstrate Lean Process Improvement methodologies in a multidisciplinary, multicenter model to screen for increased risk of breast cancer in Women Veterans. We strive to deliver a team-based, cross-functional model that meets the unique healthcare needs of female Veterans and results in a Veteran-centric delivery of care.
Relevant Background/ Problem: Women are the fastest growing veterans population seeking care at the VA Health Administration (VHA). There is also an increased risk of breast cancer in Women Veterans. Based on national guidelines we are developing tools to promote the use of screening for high risk breast cancer and its prevention as well as other breast health issues.
Methods: A 9 institution, multidisciplinary team including oncology, surgery, nursing, pharmacy, biostatistics, genetic counseling, mental health, and health systems engineering was launched at the 2014 AVAHO annual meeting. Since then, the group has met every 2 weeks by conference call and has developed subcommittees focusing on International Review Board approval, data collection, grant writing, survey design, and strategic planning. We have developed tools to collect data, CPRS research notes, and a multiple choice questionnaire.
Results: As a result of combined efforts, currently 5 studies are being conducted: Know your breast cancer risk factors and prevention options-pilot program currently enrolling patients at 2 sites. The preliminary data will be presented at AVAHO. Chemoprevention in VHA system: A VINCI data review from 2000-2015 VINCI data review of prophylactic mastectomies at VHA from 2000-2015. Survey for Primary Care physicians regarding awareness of increased risk breast cancer screening and prevention options. Lean Process Improvement project to roll out a program to increase the use of CVT so that VAMCs may offer screening and primary prevention for high risk breast cancer. Additionally, we are offering genetic counseling and plan to improve adherence to chemoprevention through the use of CVT.
Implications/Future Directions: Lean Process Improvement may be an effective method to coordinate clinical care in high risk breast cancer screening and awareness. This process should be considered as a model throughout the VHA system to offer care in accordance with national guidelines for our Women Veterans.
Purpose: To demonstrate Lean Process Improvement methodologies in a multidisciplinary, multicenter model to screen for increased risk of breast cancer in Women Veterans. We strive to deliver a team-based, cross-functional model that meets the unique healthcare needs of female Veterans and results in a Veteran-centric delivery of care.
Relevant Background/ Problem: Women are the fastest growing veterans population seeking care at the VA Health Administration (VHA). There is also an increased risk of breast cancer in Women Veterans. Based on national guidelines we are developing tools to promote the use of screening for high risk breast cancer and its prevention as well as other breast health issues.
Methods: A 9 institution, multidisciplinary team including oncology, surgery, nursing, pharmacy, biostatistics, genetic counseling, mental health, and health systems engineering was launched at the 2014 AVAHO annual meeting. Since then, the group has met every 2 weeks by conference call and has developed subcommittees focusing on International Review Board approval, data collection, grant writing, survey design, and strategic planning. We have developed tools to collect data, CPRS research notes, and a multiple choice questionnaire.
Results: As a result of combined efforts, currently 5 studies are being conducted: Know your breast cancer risk factors and prevention options-pilot program currently enrolling patients at 2 sites. The preliminary data will be presented at AVAHO. Chemoprevention in VHA system: A VINCI data review from 2000-2015 VINCI data review of prophylactic mastectomies at VHA from 2000-2015. Survey for Primary Care physicians regarding awareness of increased risk breast cancer screening and prevention options. Lean Process Improvement project to roll out a program to increase the use of CVT so that VAMCs may offer screening and primary prevention for high risk breast cancer. Additionally, we are offering genetic counseling and plan to improve adherence to chemoprevention through the use of CVT.
Implications/Future Directions: Lean Process Improvement may be an effective method to coordinate clinical care in high risk breast cancer screening and awareness. This process should be considered as a model throughout the VHA system to offer care in accordance with national guidelines for our Women Veterans.
Purpose: To demonstrate Lean Process Improvement methodologies in a multidisciplinary, multicenter model to screen for increased risk of breast cancer in Women Veterans. We strive to deliver a team-based, cross-functional model that meets the unique healthcare needs of female Veterans and results in a Veteran-centric delivery of care.
Relevant Background/ Problem: Women are the fastest growing veterans population seeking care at the VA Health Administration (VHA). There is also an increased risk of breast cancer in Women Veterans. Based on national guidelines we are developing tools to promote the use of screening for high risk breast cancer and its prevention as well as other breast health issues.
Methods: A 9 institution, multidisciplinary team including oncology, surgery, nursing, pharmacy, biostatistics, genetic counseling, mental health, and health systems engineering was launched at the 2014 AVAHO annual meeting. Since then, the group has met every 2 weeks by conference call and has developed subcommittees focusing on International Review Board approval, data collection, grant writing, survey design, and strategic planning. We have developed tools to collect data, CPRS research notes, and a multiple choice questionnaire.
Results: As a result of combined efforts, currently 5 studies are being conducted: Know your breast cancer risk factors and prevention options-pilot program currently enrolling patients at 2 sites. The preliminary data will be presented at AVAHO. Chemoprevention in VHA system: A VINCI data review from 2000-2015 VINCI data review of prophylactic mastectomies at VHA from 2000-2015. Survey for Primary Care physicians regarding awareness of increased risk breast cancer screening and prevention options. Lean Process Improvement project to roll out a program to increase the use of CVT so that VAMCs may offer screening and primary prevention for high risk breast cancer. Additionally, we are offering genetic counseling and plan to improve adherence to chemoprevention through the use of CVT.
Implications/Future Directions: Lean Process Improvement may be an effective method to coordinate clinical care in high risk breast cancer screening and awareness. This process should be considered as a model throughout the VHA system to offer care in accordance with national guidelines for our Women Veterans.
Breast Cancer Risk Assessment and Utilization of Prevention Options Among Female Veterans: A Feasibility Pilot Study
Purpose: To increase the appropriate breast cancer risk quantification, utilization of chemoprevention, and genetic counseling among Women Veterans at high risk for breast
cancer in accordance with national guidelines.
Background/Rationale: There are over 2 million women who constitute the fastest growing segment of eligible veterans within the VHA. The number of women diagnosed with breast cancer has more than tripled from 1995 to 2012. Chemoprevention reduces the risk of breast cancer by 50-62% in high risk patients. An estimated 10 million women in the U.S. may be eligible, but fewer than 5% of high risk women are offered chemoprevention.
Methods: This is an ongoing feasibility pilot study being conducted at 2 VAMCs (“VAMC 1” and “VAMC 2”) with plans for expansion to 7 more VAMCs. Participants were enrolled at the time of their regular visit to Women’s Health Clinics. Eligibility criteria includes: women age ≥ 35 with no history of breast cancer. After completing a 20 multiple choice questionnaire, 5-year and lifetime risk of invasive breast cancer is calculated using the Gail risk tool (BCRAT). A woman is considered high risk and eligible for chemoprevention if her 5-year risk is ≥ 1.67% or her lifetime risk is ≥ 20%. Eligibility for genetic counseling is based on the Breast Cancer Referral Screening Tool (B-RST), which includes a personal or family history of breast or ovarian cancer and Jewish ancestry.
Results: 72 females (42 at “VAMC 1” and 30 at “VAMC 2”) were enrolled and completed the questionnaire. Of these patients, 17/42 (40%) and 6/30 (20%) had Gail score of > 1.66 and were considered high risk for breast cancer. All 23 females at both facilities had Oncology clinic consultations for chemoprevention. Only 1 female at each center accepted chemoprevention with tamoxifen (“VAMC 1”) and anastrazole (“VAMC 2”). Six patients had telehealth genetic counseling consults.
Implications/Future Directions: Increasing awareness of breast cancer risk status and utilization of prevention options is a critical element in our program to increase screening and provide chemoprevention according to national guidelines in the VHA. Future directions include tool development and national spread of screening efforts.
Purpose: To increase the appropriate breast cancer risk quantification, utilization of chemoprevention, and genetic counseling among Women Veterans at high risk for breast
cancer in accordance with national guidelines.
Background/Rationale: There are over 2 million women who constitute the fastest growing segment of eligible veterans within the VHA. The number of women diagnosed with breast cancer has more than tripled from 1995 to 2012. Chemoprevention reduces the risk of breast cancer by 50-62% in high risk patients. An estimated 10 million women in the U.S. may be eligible, but fewer than 5% of high risk women are offered chemoprevention.
Methods: This is an ongoing feasibility pilot study being conducted at 2 VAMCs (“VAMC 1” and “VAMC 2”) with plans for expansion to 7 more VAMCs. Participants were enrolled at the time of their regular visit to Women’s Health Clinics. Eligibility criteria includes: women age ≥ 35 with no history of breast cancer. After completing a 20 multiple choice questionnaire, 5-year and lifetime risk of invasive breast cancer is calculated using the Gail risk tool (BCRAT). A woman is considered high risk and eligible for chemoprevention if her 5-year risk is ≥ 1.67% or her lifetime risk is ≥ 20%. Eligibility for genetic counseling is based on the Breast Cancer Referral Screening Tool (B-RST), which includes a personal or family history of breast or ovarian cancer and Jewish ancestry.
Results: 72 females (42 at “VAMC 1” and 30 at “VAMC 2”) were enrolled and completed the questionnaire. Of these patients, 17/42 (40%) and 6/30 (20%) had Gail score of > 1.66 and were considered high risk for breast cancer. All 23 females at both facilities had Oncology clinic consultations for chemoprevention. Only 1 female at each center accepted chemoprevention with tamoxifen (“VAMC 1”) and anastrazole (“VAMC 2”). Six patients had telehealth genetic counseling consults.
Implications/Future Directions: Increasing awareness of breast cancer risk status and utilization of prevention options is a critical element in our program to increase screening and provide chemoprevention according to national guidelines in the VHA. Future directions include tool development and national spread of screening efforts.
Purpose: To increase the appropriate breast cancer risk quantification, utilization of chemoprevention, and genetic counseling among Women Veterans at high risk for breast
cancer in accordance with national guidelines.
Background/Rationale: There are over 2 million women who constitute the fastest growing segment of eligible veterans within the VHA. The number of women diagnosed with breast cancer has more than tripled from 1995 to 2012. Chemoprevention reduces the risk of breast cancer by 50-62% in high risk patients. An estimated 10 million women in the U.S. may be eligible, but fewer than 5% of high risk women are offered chemoprevention.
Methods: This is an ongoing feasibility pilot study being conducted at 2 VAMCs (“VAMC 1” and “VAMC 2”) with plans for expansion to 7 more VAMCs. Participants were enrolled at the time of their regular visit to Women’s Health Clinics. Eligibility criteria includes: women age ≥ 35 with no history of breast cancer. After completing a 20 multiple choice questionnaire, 5-year and lifetime risk of invasive breast cancer is calculated using the Gail risk tool (BCRAT). A woman is considered high risk and eligible for chemoprevention if her 5-year risk is ≥ 1.67% or her lifetime risk is ≥ 20%. Eligibility for genetic counseling is based on the Breast Cancer Referral Screening Tool (B-RST), which includes a personal or family history of breast or ovarian cancer and Jewish ancestry.
Results: 72 females (42 at “VAMC 1” and 30 at “VAMC 2”) were enrolled and completed the questionnaire. Of these patients, 17/42 (40%) and 6/30 (20%) had Gail score of > 1.66 and were considered high risk for breast cancer. All 23 females at both facilities had Oncology clinic consultations for chemoprevention. Only 1 female at each center accepted chemoprevention with tamoxifen (“VAMC 1”) and anastrazole (“VAMC 2”). Six patients had telehealth genetic counseling consults.
Implications/Future Directions: Increasing awareness of breast cancer risk status and utilization of prevention options is a critical element in our program to increase screening and provide chemoprevention according to national guidelines in the VHA. Future directions include tool development and national spread of screening efforts.