Trial Outcomes & Findings for Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation (NCT NCT04683744)

NCT ID: NCT04683744

Last Updated: 2025-01-31

Results Overview

Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening.

Recruitment status

COMPLETED

Target enrollment

82 participants

Primary outcome timeframe

2 years

Results posted on

2025-01-31

Participant Flow

Healthcare system: we used snowball sampling to identify leadership, providers, and clinical staff involved in cancer screening, primary care and prevention. We interviewed 20 key informants in January-July 2021 and re-interviewed 11 of them in January-March 2022. Patients: we interviewed patients (screened and not screened) who were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020. Interviews were conducted from August 2021 through February 2022.

One patient that was consented, enrolled, and interviewed was removed from the study after review of data by PI and key research members concluded that the patient had undergone a diagnostic rather than screening procedure.

Participant milestones

Participant milestones
Measure
Healthcare System Leadership, Providers, and Staff
Leadership, providers, and staff at the study team's affiliated health systems. Semi-structured interviews-Health system: The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
Not Screened Patients
Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020, and did NOT complete the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Screened Patients
Patients who had at least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did completed the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Overall Study
STARTED
20
29
33
Overall Study
Interview #1
20
29
33
Overall Study
Interview #2
11
0
0
Overall Study
COMPLETED
20
29
32
Overall Study
NOT COMPLETED
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Healthcare System Leadership, Providers, and Staff
Leadership, providers, and staff at the study team's affiliated health systems. Semi-structured interviews-Health system: The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
Not Screened Patients
Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020, and did NOT complete the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Screened Patients
Patients who had at least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did completed the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Overall Study
withdrawn (determined not eligible after enrollment)
0
0
1

Baseline Characteristics

Demographic-age data for health system participants was not collected at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Not Screened Patients
n=29 Participants
Patients who were due for cancer screening (breast, cervical, colorectal or lung cancer) between April-July 2020, however had not completed the screening they were selected for at time of interview.
Screened Patients
n=32 Participants
Patients who were due for cancer screening (breast, cervical, colorectal or lung cancer) between April-July 2020 and had completed the screening they were selected for at time of interview.
Health System Participants
n=20 Participants
Leadership, providers, and clinical staff involved in cancer screening, primary care, and prevention at two affiliated health systems.
Total
n=81 Participants
Total of all reporting groups
Age, Continuous
56.1 years
STANDARD_DEVIATION 15.1 • n=29 Participants • Demographic-age data for health system participants was not collected at baseline.
56.2 years
STANDARD_DEVIATION 14.5 • n=32 Participants • Demographic-age data for health system participants was not collected at baseline.
56.1 years
STANDARD_DEVIATION 14.7 • n=61 Participants • Demographic-age data for health system participants was not collected at baseline.
Sex/Gender, Customized
Female
24 Participants
n=29 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
23 Participants
n=32 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
47 Participants
n=61 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
Sex/Gender, Customized
Male
4 Participants
n=29 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
9 Participants
n=32 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
13 Participants
n=61 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
Sex/Gender, Customized
Other
1 Participants
n=29 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
0 Participants
n=32 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
1 Participants
n=61 Participants • Demographic-sex/gender data for health system participants was not collected at baseline.
Race/Ethnicity, Customized
White
17 Participants
n=29 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
16 Participants
n=32 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
33 Participants
n=61 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
Race/Ethnicity, Customized
Black or African American
11 Participants
n=29 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
13 Participants
n=32 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
24 Participants
n=61 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
Race/Ethnicity, Customized
Other
1 Participants
n=29 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
3 Participants
n=32 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
4 Participants
n=61 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
Race/Ethnicity, Customized
Hispanic/Latino
0 Participants
n=29 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
0 Participants
n=32 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
0 Participants
n=61 Participants • Demographic-race and ethnicity data for Health system participants was not collected at baseline.
Living Situation
Never Married
7 Participants
n=29 Participants • Living situation data will not be collected for health system participants.
9 Participants
n=32 Participants • Living situation data will not be collected for health system participants.
16 Participants
n=61 Participants • Living situation data will not be collected for health system participants.
Living Situation
Married/Living with a Partner
14 Participants
n=29 Participants • Living situation data will not be collected for health system participants.
13 Participants
n=32 Participants • Living situation data will not be collected for health system participants.
27 Participants
n=61 Participants • Living situation data will not be collected for health system participants.
Living Situation
Divorced
3 Participants
n=29 Participants • Living situation data will not be collected for health system participants.
4 Participants
n=32 Participants • Living situation data will not be collected for health system participants.
7 Participants
n=61 Participants • Living situation data will not be collected for health system participants.
Living Situation
Separated
0 Participants
n=29 Participants • Living situation data will not be collected for health system participants.
1 Participants
n=32 Participants • Living situation data will not be collected for health system participants.
1 Participants
n=61 Participants • Living situation data will not be collected for health system participants.
Living Situation
Widowed
5 Participants
n=29 Participants • Living situation data will not be collected for health system participants.
5 Participants
n=32 Participants • Living situation data will not be collected for health system participants.
10 Participants
n=61 Participants • Living situation data will not be collected for health system participants.
Highest Level of Education
Less than high school diploma
2 Participants
n=29 Participants • Education level will not be collected for health system participants.
3 Participants
n=32 Participants • Education level will not be collected for health system participants.
5 Participants
n=61 Participants • Education level will not be collected for health system participants.
Highest Level of Education
High school graduate/GED
12 Participants
n=29 Participants • Education level will not be collected for health system participants.
7 Participants
n=32 Participants • Education level will not be collected for health system participants.
19 Participants
n=61 Participants • Education level will not be collected for health system participants.
Highest Level of Education
Some college/technical or trade school
7 Participants
n=29 Participants • Education level will not be collected for health system participants.
10 Participants
n=32 Participants • Education level will not be collected for health system participants.
17 Participants
n=61 Participants • Education level will not be collected for health system participants.
Highest Level of Education
Associate degree
0 Participants
n=29 Participants • Education level will not be collected for health system participants.
4 Participants
n=32 Participants • Education level will not be collected for health system participants.
4 Participants
n=61 Participants • Education level will not be collected for health system participants.
Highest Level of Education
Bachelor's degree
6 Participants
n=29 Participants • Education level will not be collected for health system participants.
7 Participants
n=32 Participants • Education level will not be collected for health system participants.
13 Participants
n=61 Participants • Education level will not be collected for health system participants.
Highest Level of Education
Professional or graduate degree
2 Participants
n=29 Participants • Education level will not be collected for health system participants.
1 Participants
n=32 Participants • Education level will not be collected for health system participants.
3 Participants
n=61 Participants • Education level will not be collected for health system participants.
Employment Status
Unemployed/retired
21 Participants
n=29 Participants • Employment status data will not be collected from health system participants.
16 Participants
n=32 Participants • Employment status data will not be collected from health system participants.
37 Participants
n=61 Participants • Employment status data will not be collected from health system participants.
Employment Status
Employed Full-time
6 Participants
n=29 Participants • Employment status data will not be collected from health system participants.
9 Participants
n=32 Participants • Employment status data will not be collected from health system participants.
15 Participants
n=61 Participants • Employment status data will not be collected from health system participants.
Employment Status
Employed Part-time
2 Participants
n=29 Participants • Employment status data will not be collected from health system participants.
6 Participants
n=32 Participants • Employment status data will not be collected from health system participants.
8 Participants
n=61 Participants • Employment status data will not be collected from health system participants.
Employment Status
Unknown
0 Participants
n=29 Participants • Employment status data will not be collected from health system participants.
1 Participants
n=32 Participants • Employment status data will not be collected from health system participants.
1 Participants
n=61 Participants • Employment status data will not be collected from health system participants.
Subjective Health Status
Excellent
1 Participants
n=29 Participants • Subject Health Status data will not be collected from health system participants.
1 Participants
n=32 Participants • Subject Health Status data will not be collected from health system participants.
2 Participants
n=61 Participants • Subject Health Status data will not be collected from health system participants.
Subjective Health Status
Very good
3 Participants
n=29 Participants • Subject Health Status data will not be collected from health system participants.
6 Participants
n=32 Participants • Subject Health Status data will not be collected from health system participants.
9 Participants
n=61 Participants • Subject Health Status data will not be collected from health system participants.
Subjective Health Status
Good
14 Participants
n=29 Participants • Subject Health Status data will not be collected from health system participants.
16 Participants
n=32 Participants • Subject Health Status data will not be collected from health system participants.
30 Participants
n=61 Participants • Subject Health Status data will not be collected from health system participants.
Subjective Health Status
Fair
7 Participants
n=29 Participants • Subject Health Status data will not be collected from health system participants.
7 Participants
n=32 Participants • Subject Health Status data will not be collected from health system participants.
14 Participants
n=61 Participants • Subject Health Status data will not be collected from health system participants.
Subjective Health Status
Poor
4 Participants
n=29 Participants • Subject Health Status data will not be collected from health system participants.
2 Participants
n=32 Participants • Subject Health Status data will not be collected from health system participants.
6 Participants
n=61 Participants • Subject Health Status data will not be collected from health system participants.
Subjective Income
Are comfortable
7 Participants
n=29 Participants • Subjective Income data will not be collected from health system participants.
15 Participants
n=32 Participants • Subjective Income data will not be collected from health system participants.
22 Participants
n=61 Participants • Subjective Income data will not be collected from health system participants.
Subjective Income
Have just enough to make ends meet
14 Participants
n=29 Participants • Subjective Income data will not be collected from health system participants.
14 Participants
n=32 Participants • Subjective Income data will not be collected from health system participants.
28 Participants
n=61 Participants • Subjective Income data will not be collected from health system participants.
Subjective Income
Do NOT have enough to make ends meet
7 Participants
n=29 Participants • Subjective Income data will not be collected from health system participants.
3 Participants
n=32 Participants • Subjective Income data will not be collected from health system participants.
10 Participants
n=61 Participants • Subjective Income data will not be collected from health system participants.
Subjective Income
Unknown
1 Participants
n=29 Participants • Subjective Income data will not be collected from health system participants.
0 Participants
n=32 Participants • Subjective Income data will not be collected from health system participants.
1 Participants
n=61 Participants • Subjective Income data will not be collected from health system participants.
Difficulty Understanding Written Information
Always
2 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
0 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
2 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Difficulty Understanding Written Information
Often
0 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
1 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
1 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Difficulty Understanding Written Information
Sometimes
7 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
8 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
15 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Difficulty Understanding Written Information
Occasionally
7 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
5 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
12 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Difficulty Understanding Written Information
Never
13 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
18 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
31 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Confidence Filling Out Medical Forms
Extremely
15 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
21 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
36 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Confidence Filling Out Medical Forms
Quite a bit
5 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
5 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
10 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Confidence Filling Out Medical Forms
Somewhat
4 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
4 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
8 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Confidence Filling Out Medical Forms
A little bit
1 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
1 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
2 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Confidence Filling Out Medical Forms
Not at all
4 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
1 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
5 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Have Help Reading Hospital Materials
Always
2 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
0 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
2 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Have Help Reading Hospital Materials
Often
2 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
2 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
4 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Have Help Reading Hospital Materials
Sometimes
4 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
4 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
8 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Have Help Reading Hospital Materials
Occasionally
7 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
6 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
13 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Have Help Reading Hospital Materials
Never
14 Participants
n=29 Participants • Health literacy data will not be collected from health system participants.
20 Participants
n=32 Participants • Health literacy data will not be collected from health system participants.
34 Participants
n=61 Participants • Health literacy data will not be collected from health system participants.
Health System Roles
Leadership/Administration
9 Participants
n=20 Participants • Health system role data was only collected from health system participants.
9 Participants
n=20 Participants • Health system role data was only collected from health system participants.
Health System Roles
Provider (MD, DO, APP)
5 Participants
n=20 Participants • Health system role data was only collected from health system participants.
5 Participants
n=20 Participants • Health system role data was only collected from health system participants.
Health System Roles
Clinical Support (MA, RN)
6 Participants
n=20 Participants • Health system role data was only collected from health system participants.
6 Participants
n=20 Participants • Health system role data was only collected from health system participants.

PRIMARY outcome

Timeframe: 2 years

Population: The initial sample of 8 interviewees identified 12 additional stakeholders, allowing us to "snowball" our sample to complete interviews with 20 participants including primary care providers, nurses, medical assistants, quality and clinic managers, and cancer screening program managers.

Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening.

Outcome measures

Outcome measures
Measure
Healthcare System Leadership, Providers, and Staff
n=20 Participants
Leadership, providers, and staff at the study team's affiliated health systems. Semi-structured interviews-Health system: The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
Screened Patients
Patients who had at least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did complete the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.
Themes: Facilitators identified
6 Themes
Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.
Themes: Barriers identified
8 Themes

PRIMARY outcome

Timeframe: 9 months

Population: 20 leaders, managers, and providers were interviewed in January-July 2021, and 11 were re-interviewed in January-March 2022. We identified five emergent, overarching themes of the impact of COVID-19 pandemic on cancer screening and preventive care services across two healthcare organizations and across the time frame of the COVID-19 pandemic (2020-2022).

Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening.

Outcome measures

Outcome measures
Measure
Healthcare System Leadership, Providers, and Staff
n=20 Participants
Leadership, providers, and staff at the study team's affiliated health systems. Semi-structured interviews-Health system: The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
Screened Patients
Patients who had at least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did complete the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff.
5 Themes

PRIMARY outcome

Timeframe: 6 months

Population: We interviewed 32 patients who completed screening in 2020 and 29 patients who did not complete the relevant screening test from April 2020 to the date of the interview.

Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making.

Outcome measures

Outcome measures
Measure
Healthcare System Leadership, Providers, and Staff
n=29 Participants
Leadership, providers, and staff at the study team's affiliated health systems. Semi-structured interviews-Health system: The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
Screened Patients
n=32 Participants
Patients who had at least one primary care visit during the past 24 months at the study team's affiliated health care systems, were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020 and did complete the screening they were selected for at time of interview. Semi-structured interviews-Patients: The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.
Cancer Screening
3 Themes
3 Themes
Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.
Other Healthcare Services (non-screening)
4 Themes
4 Themes
Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.
Health Information
3 Themes
3 Themes

Adverse Events

Healthcare System Leadership, Providers, and Staff

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Not Screened Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Screened Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter H. Schwartz

Indiana University

Phone: 317-278-4037

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place