Lung Cancer Screening Decisions
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 55 - 80 |
| Updated: | 2/2/2019 |
| Start Date: | January 28, 2019 |
| End Date: | February 28, 2020 |
| Contact: | Marilyn M Schapira, MD MPH |
| Email: | Marilyn.Schapira@va.gov |
| Phone: | (215) 823-5800 |
Incorporating Veterans Preferences Into Lung Cancer Screening Decisions
Veterans have a high risk of developing lung in comparison to general populations due to
their older age and smoking history. Recent evidence indicates that lung cancer screening
with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the
rates of false positive findings are high, requiring further testing and evaluation.
Preliminary studies report that while some Veterans are enthusiastic about screening, others
are highly reluctant. Patient preferences should be considered as part of an informed
decision making process for this emerging paradigm of lung cancer control. Effective methods
for preference assessment among Veterans have not yet been developed, evaluated, and
integrated into clinical practice. The specific aims of this study are to 1) elicit patient
and provider stakeholder input to inform the development of a lung cancer screening decision
tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that
incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool
compared to usual care on the decision process, clinical outcomes, and quality of life.
(5/8/18)-This project involves the recruitment of both Veterans as well as health care
providers/leaders. Patient recruitment efforts at both sites will target male and female
patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer
screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients,
and 10% women. To Date, 32 Veterans have signed the consent form and completed their portion
of the trial (16 at CMCVAMC and 16 at West Haven, CT). To Date, 61 Providers have completed
their portion of the trial (18 at CMCVAMC and 43 at West Haven, CT). Enrollment for Phase 1
is complete. Enrollment for Phase 2 will begin in June, 2018.
To Date (10/25/2018) Patient recruitment efforts at both sites will target male and female
patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer
screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients,
and 10% women. To Date, 9 Veterans have signed the consent form and completed their portion
of the trial (9 at CMCVAMC and 0 at West Haven, CT). Enrollment for Phase 2 is ongoing with
the intent to complete By November 30, 2018.
Phase 3 recruitment is estimated to begin January 2, 2018
their older age and smoking history. Recent evidence indicates that lung cancer screening
with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the
rates of false positive findings are high, requiring further testing and evaluation.
Preliminary studies report that while some Veterans are enthusiastic about screening, others
are highly reluctant. Patient preferences should be considered as part of an informed
decision making process for this emerging paradigm of lung cancer control. Effective methods
for preference assessment among Veterans have not yet been developed, evaluated, and
integrated into clinical practice. The specific aims of this study are to 1) elicit patient
and provider stakeholder input to inform the development of a lung cancer screening decision
tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that
incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool
compared to usual care on the decision process, clinical outcomes, and quality of life.
(5/8/18)-This project involves the recruitment of both Veterans as well as health care
providers/leaders. Patient recruitment efforts at both sites will target male and female
patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer
screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients,
and 10% women. To Date, 32 Veterans have signed the consent form and completed their portion
of the trial (16 at CMCVAMC and 16 at West Haven, CT). To Date, 61 Providers have completed
their portion of the trial (18 at CMCVAMC and 43 at West Haven, CT). Enrollment for Phase 1
is complete. Enrollment for Phase 2 will begin in June, 2018.
To Date (10/25/2018) Patient recruitment efforts at both sites will target male and female
patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer
screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients,
and 10% women. To Date, 9 Veterans have signed the consent form and completed their portion
of the trial (9 at CMCVAMC and 0 at West Haven, CT). Enrollment for Phase 2 is ongoing with
the intent to complete By November 30, 2018.
Phase 3 recruitment is estimated to begin January 2, 2018
Lung cancer is the leading cause of cancer deaths in the United States. Recent clinical
trials provide evidence that screening with low dose CT scans will decrease lung cancer and
all cause mortality among older heavy smokers. Clinical guidelines have been issued with the
USPSTF recommending annual screening from age 55 to 80 for those with 30 pack years or more
of smoking or who quit less than 15 years ago. Evidence clearly delineates both the benefits
(mortality reduction) and harms (false positives, follow-up testing, risk of invasive
testing, and risk of overdiagnosis) of lung cancer screening. Preliminary data from an HSR&D
pilot grant finds that some Veterans are highly reluctant to enter the care pathway
associated with lung cancer screening due to its potential harms. Additional preliminary data
using Best Worst Scaling in older smokers demonstrate groups of patients who place greater
importance on harms than benefit when considering lung cancer screening. Preference
assessment methods can help Veterans to weigh benefits and harms, consider the clinical
pathway they are entering, anticipate future health states, and communicate these values to
their health care providers. Although basic educational tools to inform lung cancer
decision-making have been developed, there is a lack of validated preference assessment tools
that can be integrated into the clinical setting. Building upon preference assessment methods
developed and validated in an HSR&D pilot grant (PI-Schapira) and using a trans-disciplinary
approach, this team is positioned to advance the science and practice of decision support for
lung cancer screening in the Veteran population. The objectives of this study are to 1)
elicit patient and provider stakeholder input to inform the development of a lung cancer
screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool
(LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the
LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of
life. The study will be conducted in 3 phases. In phase 1, mixed methods will be used to
assess usability of preference assessment methods and perceived usefulness of a web based
lung cancer screening decision support tool among patient and provider stakeholders. In phase
2, an interactive web based decision support program will be developed that incorporates
preference assessment methods. In phase 3, a pilot RCT will be conduced to evaluate the
efficacy of the web based decision support program. Outcomes evaluated will include decision
quality as indicated by knowledge, decisional conflict, and decision regret; screening
behavior, clinical outcomes as indicated by anxiety, and quality of life. The study will be
conducted across two VA sites; West Haven-VA in Connecticut and Corporal Michael J. Crescenz
VA in Philadelphia, Pennsylvania. Results of this study will provide tools that can be used
to integrate lung cancer screening into clinical practice at VA Medical Centers in a patient
centered approach. Lung cancer screening is fundamentally different from existing screening
paradigms in several respects; eligibility is defined by a behavior (smoking), a high rate of
false positive findings is expected, and the target population is older with higher
comorbidity than the target population for cervical, breast, or colorectal screening. Given
these unique aspects of lung cancer screening, there is a critical need to develop and test
tools for preference assessment and informed decision making that are applicable for the VA
setting. The current proposal provides a mechanism to accomplish these goals. The Principal
Investigator is working closely with the US Department of Veterans Affairs National Center
for Health Promotion and Disease Prevention to integrate the tools and paradigm developed to
primary care in the VA Medical Care System. The work builds directly upon a recently
completed HSR&D pilot support in the area of lung cancer and shared decision making.
trials provide evidence that screening with low dose CT scans will decrease lung cancer and
all cause mortality among older heavy smokers. Clinical guidelines have been issued with the
USPSTF recommending annual screening from age 55 to 80 for those with 30 pack years or more
of smoking or who quit less than 15 years ago. Evidence clearly delineates both the benefits
(mortality reduction) and harms (false positives, follow-up testing, risk of invasive
testing, and risk of overdiagnosis) of lung cancer screening. Preliminary data from an HSR&D
pilot grant finds that some Veterans are highly reluctant to enter the care pathway
associated with lung cancer screening due to its potential harms. Additional preliminary data
using Best Worst Scaling in older smokers demonstrate groups of patients who place greater
importance on harms than benefit when considering lung cancer screening. Preference
assessment methods can help Veterans to weigh benefits and harms, consider the clinical
pathway they are entering, anticipate future health states, and communicate these values to
their health care providers. Although basic educational tools to inform lung cancer
decision-making have been developed, there is a lack of validated preference assessment tools
that can be integrated into the clinical setting. Building upon preference assessment methods
developed and validated in an HSR&D pilot grant (PI-Schapira) and using a trans-disciplinary
approach, this team is positioned to advance the science and practice of decision support for
lung cancer screening in the Veteran population. The objectives of this study are to 1)
elicit patient and provider stakeholder input to inform the development of a lung cancer
screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool
(LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the
LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of
life. The study will be conducted in 3 phases. In phase 1, mixed methods will be used to
assess usability of preference assessment methods and perceived usefulness of a web based
lung cancer screening decision support tool among patient and provider stakeholders. In phase
2, an interactive web based decision support program will be developed that incorporates
preference assessment methods. In phase 3, a pilot RCT will be conduced to evaluate the
efficacy of the web based decision support program. Outcomes evaluated will include decision
quality as indicated by knowledge, decisional conflict, and decision regret; screening
behavior, clinical outcomes as indicated by anxiety, and quality of life. The study will be
conducted across two VA sites; West Haven-VA in Connecticut and Corporal Michael J. Crescenz
VA in Philadelphia, Pennsylvania. Results of this study will provide tools that can be used
to integrate lung cancer screening into clinical practice at VA Medical Centers in a patient
centered approach. Lung cancer screening is fundamentally different from existing screening
paradigms in several respects; eligibility is defined by a behavior (smoking), a high rate of
false positive findings is expected, and the target population is older with higher
comorbidity than the target population for cervical, breast, or colorectal screening. Given
these unique aspects of lung cancer screening, there is a critical need to develop and test
tools for preference assessment and informed decision making that are applicable for the VA
setting. The current proposal provides a mechanism to accomplish these goals. The Principal
Investigator is working closely with the US Department of Veterans Affairs National Center
for Health Promotion and Disease Prevention to integrate the tools and paradigm developed to
primary care in the VA Medical Care System. The work builds directly upon a recently
completed HSR&D pilot support in the area of lung cancer and shared decision making.
Inclusion Criteria:
- Age 55-80 years
- Enrolled in a Patient Aligned Care Team at a participating site
- 30 or more pack years of smoking
- Active smoker or quit smoking within 15 years
Exclusion Criteria:
- Cognitive impairment as determined by clinical history Previous diagnosis of cancer
with the exception of non-melanoma skin cancer
- Life expectancy of less than 2 years as indicated by chart review and conformation
with PCPC
- Inability to speak English
We found this trial at
2
sites
West Haven, Connecticut 06516
Phone: (203) 932-5711
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3900 Woodland Avenue
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Principal Investigator: Marilyn M. Schapira, MD MPH
Phone: 215-823-5800
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