The experimental information consists of receiving verbal and written evidence-based information about the benefits and risks of mammography screening program. The standard information consists of receiving the information that public institutions provide to the women invited to the screening program.

Information

José M Baena-Cañada, MD, PhD

Petra Rosado, MD

Inmaculada Expósito, Chemistry

María del Carmen Díaz, Chemistry

Juan Nieto, MD

Study objectives: to evaluate the effects of information about benefits and risks of mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and risks of mammography screening increases the women´s knowledge of it; allows women to make an informed decision on whether to stop or continue the screening program, changing the actual participation rate; anxiety and fear are not increased. Design: randomized controlled clinical trial with non-pharmacological intervention. Subjects and setting of study: women referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions: random assignment of women in two arms according to the information provided. Control arm is the standard information; it consists of receiving information normally provided to women attending the screening program for breast cancer. Intervention arm is the experimental information and consists of receiving accurate verbal and written information about the benefits and real risks of mammography screening programs by a physician investigator. Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision.

Evidence-informed Choice for Women Participating in Mammography Screening

A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening

The primary outcome measure is the level of knowledge obtained in a specific questionnaire, in which there are 7 questions, of which 3 are quantitative with no assumptions and are scored with 2 points. There are also 4 qualitative questions that have 3 assumptions which are scored with 1 point. The maximum score is 10 and minimum 0. It is considered that a woman has made a choice based on adequate knowledge if she gets a score of 6 or more.

The investigators will investigate whether the attitudes of women towards mammography screening are positive or negative. They will respond to 4 questions that are scored from 0 to 6. To know their decision whether to participate in mammography screening they will answer "I am determined to participate" "I am determined not to participate" and "I am undecided". Effective participation will be investigated 2 years later. The level of anxiety and fear of cancer will be measured by "Hospital Anxiety and depression" scale.

Andaluz Health Service

MD, PhD

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system

Care normally provided by a nurse in the endoscopy department of the healthcare system

A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.

Tailored DVD

Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support.

Patient Navigation

Susan M Rawl, PhD,RN

The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.

The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care.

Colorectal cancer (CRC) often can be prevented through regular screening and although multiple screening tests are available, colonoscopy is often the only screening test offered to patients. Unfortunately, up to half of people in some hospitals who receive a recommendation and are scheduled for colonoscopy do not complete the test. Reasons for not completing colonoscopy include lack of awareness of the need for, and benefits of, screening, fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost, transportation issues, and the unwillingness to undergo an invasive test in the absence of symptoms. The process of bowel cleansing is one of the most challenging aspects of having a colonoscopy. Interventions that improve patients' knowledge about CRC screening, including test options other than colonoscopy, enhance access, improve skills needed to complete CRC screening, and reduce barriers will lead to greater numbers of people being screened. Patient navigation and computer tailored interventions have been shown to be effective approaches to increase CRC and other cancer screening but there is no evidence of their comparative effectiveness. The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a diverse sample of patients. The investigators will enroll an ethnically diverse group of 450 men and women aged 50-75,or aged 45-75 if African American, who are at average risk for CRC and were referred and scheduled for colonoscopy at one endoscopy department but canceled or did not attend their scheduled appointment. Participants will be randomized to receive: (1) a mailed tailored digital video disc (DVD) alone; 2) the mailed tailored DVD plus a telephone-based Patient Navigator; or 3) usual care. Data will be collected at baseline, at 6 months and at 9 months post-baseline. Interviews to assess receipt, viewing, and satisfaction with the tailored DVD will be conducted 2 weeks after mailing. Satisfaction with the patient navigator will be assessed at 6 months. Multivariable logistic regression analyses will be used to test the interventions' effects on CRC screening test completion and, for those who complete colonoscopy, quality of bowel preparation. The investigators will also examine whether these interventions change knowledge about CRC and screening as well as health beliefs (perceived risk, perceived benefits, barriers, and self-efficacy) about screening. From this study, the investigators will learn how effective these two standardized, easy to disseminate health system-based interventions are compared to each other and to usual care. If the interventions are found to be equally effective, or differentially effective for different subgroups of patients, healthcare systems may consider implementing one or both of these interventions in their settings.

Comparing Interventions to Increase Colorectal Cancer Screening

Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients

A copy of the complete, cleaned, de-identified data set used to conduct the final analyses will be made available in SAS and SPSS formats.

Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review. Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record.

Number of participants completing a colonoscopy is measured by electronic medical record review (EMR). Dates that participants completed a colonoscopy are extracted from the EMR.

Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy procedure using the Boston Bowel Preparation Scale (BBPS). BBPS scores the total quality on a 10 point scale from 0-9. Higher scores indicate better quality of bowel preparation.

Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy using a modification of the Aronchick rating scale. The Aronchick scale rates quality as 1=excellent, 2=good, 3=fair, or 4=poor. Some endoscopists choose to grade quality more generally as adequate vs. inadequate. To accommodate this variation, bowel preparation ratings have been dichotomized into adequate (excellent, good, fair, or adequate ratings) vs. inadequate (poor or inadequate ratings). Adequate is scored as 1 and indicates better quality of bowel preparation than inadequate which is scored as 0.

Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety.

Satisfaction with the colonoscopy experience is measured by self-report using a single item developed by the research team. Satisfaction is rated from 1 to 4 where 1=not at all satisfied, 2=a little satisfied, 3=mostly satisfied, and 4=completely satisfied. Scores range from 1 to 4 with higher scores indicating greater satisfaction.

Number of participants completing a FIT is measured by electronic medical record review (EMR). Dates of FIT analysis are extracted from the EMR.

Number of participants who reported completing CRC screening by any test (defined as colonoscopy or FIT) during the 6 or 9 month post-baseline telephone interview.

Number of participants who reported completing a colonoscopy during the 6 or 9 month post-baseline telephone interview.

Number of participants who reported completing a FIT during the 6 or 9 month post-baseline telephone interview.

Change from baseline in knowledge of CRC and screening is measured at 6 months by self-report using a 9-item multidimensional scale. Each item is scored as 1=correct or 0=incorrect and summed to yield a scale score. Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests. The mean of the 9 items is calculated at baseline and 6 months post-baseline. Change from baseline equals the mean at 6 months minus the mean at baseline. Change can range from -9 to 9 with positive values indicating an increase in knowledge.

Change from baseline in perceived risk for CRC is measured by self-report at 6 months using a 3-item scale. We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely). Higher scores indicate a higher perceived risk for getting CRC. The mean of the 3 items is calculated at baseline and 6 months. Change in perceived risk equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived risk for getting CRC.

Change from baseline in colonoscopy-related procedural anxiety is measured at 6 months by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety. The mean of the 6 items is calculated at baseline and 6 months post-baseline. Change from baseline is the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in anxiety.

Change from baseline in perceived benefits of CRC screening by colonoscopy is measured at 6 months by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 4 items calculated. Higher mean scores indicate greater perceived benefits of screening by colonoscopy. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits of screening by colonoscopy.

Change from baseline in perceived barriers to CRC screening by colonoscopy is measured at 6 months by self-report using a 16-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 16 items calculated. Higher mean scores indicate greater perceived barriers to screening by colonoscopy. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by colonoscopy.

Change from baseline in perceived self-efficacy for colonoscopy is measured at 6 months by self-report using an 11-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 11 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by colonoscopy. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by colonoscopy.

Change from baseline in perceived benefits of CRC screening by FIT is measured at 6 months by self-report using a 3-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 3 items calculated. Higher mean scores indicate greater perceived benefits of screening by FIT. Change in perceived benefits equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived benefits for screening by FIT.

Change from baseline in perceived barriers to CRC screening by FIT is measured at 6 months by self-report using a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 10 items calculated. Higher mean scores indicate greater perceived barriers to screening by FIT. Change in perceived barriers equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by FIT.

Change from baseline in perceived self-efficacy for CRC screening by FIT is measured at 6 months by self-report using a 7-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 7 items calculated. Higher mean scores indicate greater perceived self-efficacy for screening by FIT. Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline. Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by FIT.

Patient-Centered Outcomes Research Institute

Ohio State University

Indiana University

Professor

Tailored digital video disc (DVD)

Tailored DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.

Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system

Tailored DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.

Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support.

Tailored DVD + Patient Navigation

Usual Care

Tailored digital video disc (DVD)

DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.

Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system

DVD: A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.

Patient Navigation: Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support.

Total

Age, Continuous

Sex: Female, Male

Non-Hispanic Whte

Non-Hispanic Non-White

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Participants who are either married or living with a partner.

Enrolled participants who completed the baseline interview. Excludes 1 participant from the Tailored DVD + Patient Navigation group whose data were missing.

Married/Partnered

Participants highest grade or year of school completed.

Enrolled participants who completed the baseline interview. Excludes 1 participant in Usual Care group whose data were missing.

Education

Number of persons, including the participant, who live in their household.

Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD group whose data were missing. Excludes 3 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group whose data were missing.

Number in Household

Participants with children younger than 18 living in their household.

Enrolled participants who completed the baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in the Usual Care group whose data were missing.

Children Under Age 18 in Household

Enrolled participants who completed the baseline interview. Excludes 1 participant in the Usual Care group whose data were missing.

Employment Status

Total combined yearly household income before taxes.

Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD group whose data were missing. Excludes 6 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 5 participants in the Usual Care group whose data were missing.

Household Income

Total combined yearly household income before taxes, categorized as below $15,000 vs. $15,000 or more.

Household Income Categorized by $15K Level

Participants described the adequacy of their household income to pay for things.

Enrolled participants who completed the baseline interview. Excludes 4 participants in the Tailored DVD group whose data were missing. Excludes 7 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 6 participants in the Usual Care group whose data were missing.

Adequacy of Income

Participants covered by health insurance or some other kind of health care plan.

Health Insurance Coverage

Body mass index (BMI) is an estimate of body fat that is calculated using participants self report of height and weight. BMI values are correlated with weight categories. A BMI \<18.5 means underweight; BMI=18.5-24.9 means normal weight; BMI=25.0-29.9 means overweight; and BMI \> 30 means obese. A high BMI is associated with an increased risk for chronic diseases such as heart disease, high blood pressure, and type 2 diabetes.

Enrolled participants who completed the baseline interview. Excludes 3 participants in the Tailored DVD + Patient Navigation group whose data were missing.

Body Mass Index (BMI)

Global physical health status was measured using the subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS) validated instrument. The subscale uses 4 items and measures general physical health, physical functioning, pain, and fatigue. Response options range from 1=poor to 5=excellent. Scores range from a minimum of 4 to a maximum of 20. Higher scores indicate better physical health.

Enrolled participants who completed the baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 3 participants in the Usual Care group whose data were missing.

Global Physical Health

Global mental health status was measured using the subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS) validated instrument. The subscale uses 4 items and measures quality of life, general mental health, satisfaction with social activities/relationships, and emotional problems. Response options range from 1=poor to 5=excellent. Scores range from a minimum of 4 to a maximum of 20. Higher scores indicate better mental health.

Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing.

Global Mental Health

Health literacy was measured using Chew's Brief Health Literacy Screen validated instrument. This 3-item scale assesses participants' confidence in filling out medical forms independently, if they need help from others to read hospital materials, and if they have problems learning about their medical condition because of difficulty understanding written information. Recoded response options range from 1=no confidence/always need help/always difficult to 5=extremely confident/never need help/never difficult. Scores range from 3 to 15. Higher scores indicate greater health literacy.

Enrolled participants who completed the baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing.

Health Literacy

Comorbidity was measured by self-report using Sangha's comordibity questionnaire. Twelve common health problems (heart disease, high blood pressure, diabetes, etc.) are assessed by asking participants if they ever had the problem, if they currently receive treatment for it, and if it currently limits their activities. Each question is scored as yes=1 or no=0 resulting in a possible score of 0 to 3 per health problem. Scale scores range from 0 to 36. Higher scale scores indicate greater comorbidity.

Comorbidity

Knowledge of CRC and screening is measured by self-report using a 9-item multidimensional scale. Each item is scored as 1=correct or 0=incorrect, summed to yield a scale score, and the mean calculated. Scores range from 0 to 9. Higher scale scores and means indicate greater knowledge of CRC and screening tests.

Knowledge of CRC and Screening

Perceived risk for CRC is measured by self-report using a 3-item scale. We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years. Each item is scored from 1 to 4 (1=very unlikely; 4=very likely) and the mean of the 3 items calculated. Higher mean scores indicate a greater perceived risk for getting CRC.

Enrolled participants who completed the baseline interview. Excludes 9 participants in the Tailored DVD group whose data were missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 4 participants in the Usual Care group whose data were missing.

Perceived Risk for CRC

Participants staged in terms of their readiness screen for CRC by having a colonoscopy. If not planning to have a colonoscopy in the next 6 months, staging was precontemplation. If planning to have a colonoscopy in the next 6 months, but no appointment scheduled, staging was contemplation. If an appointment was scheduled to have a colonoscopy within the next 6 months, staging was preparation.

Colonoscopy Stage of Adoption

Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory. Each item is scored from 1 to 4 (1=not at all; 4=very much so) and the mean of the 4 items calculated. Higher mean scores indicate greater anxiety.

Excludes 1 participant in the Tailored DVD group whose data were missing.

Colonoscopy-Related Procedural Anxiety

Perceived benefits of CRC screening by colonoscopy is measured by self-report using a 4-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 4 items calculated. Higher mean scores indicate greater perceived benefits of screening by colonoscopy.

Enrolled participants who completed the baseline interview. Excludes 2 participants in the Tailored DVD group whose data was missing. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data was missing.

Perceived Benefits of CRC Screening by Colonoscopy

Perceived barriers to colonoscopy is measured by self-report using a 16-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 16 items calculated. Higher mean scores indicate greater perceived barriers to screening by colonoscopy.

Perceived Barriers to CRC Screening by Colonoscopy

Perceived self-efficacy for colonoscopy is measured by self-report using an 11-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 11 items calculated. Higher mean scores indicate greater perceived self-efficacy for CRC screening by colonoscopy.

Perceived Self-Efficacy for CRC Screening by Colonoscopy

Participants staged in terms of their readiness to adopt an at-home fecal immunochemical test (FIT) to screen for CRC. If not planning to do a FIT in the next 6 months, staging was precontemplation. If planning to do a FIT in the next 6 months, but did not have a FIT kit at home, staging was contemplation. If planning to do a FIT within the next 6 months and had a FIT kit at home, staging was preparation. If a FIT was already done within the last 12 months, staging was action.

Fecal Immunochemical Test Stage of Adoption

Perceived benefits of CRC screening by FIT is measured by self-report using a 3-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 3 items calculated. Higher mean scores indicate greater perceived benefits of screening by FIT.

Enrolled participants who completed the baseline interview. Excludes 6 participants in the Tailored DVD group whose data were missing. Excludes 3 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group whose data were missing.

Perceived Benefits of CRC Screening by FIT

Perceived barriers to FIT is measured by self-report using a 10-item scale. Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 10 items calculated. Higher mean scores indicate greater perceived barriers to screening by FIT.

Perceived Barriers to CRC Screening by FIT

Perceived self-efficacy for FIT is measured by self-report using a 7-item scale. Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 7 items calculated. Higher mean scores indicate greater perceived self-efficacy for CRC screening by FIT.

Perceived Self-Efficacy for CRC Screening by FIT

Susan M. Rawl, PhD, RN, FAAHB, FAAN

All enrolled participants who completed the baseline interview and were randomized.

Participants Completing CRC Screening Per Electronic Medical Record Documentation

Participants Completing Colonoscopy Per Electronic Medical Record Documentation

All participants who completed a colonoscopy per EMR documentation. Analysis excludes 1 participant in Usual Care group whose BBPS score was missing.

Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale

All participants who completed a colonoscopy per EMR documentation.

Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale

Participants who completed a colonoscopy within 12 months of the baseline interview per EMR documentation and self-reported on colonoscopy-related anxiety during the 6 or 9 month post-baseline interview. Excludes 6 participants in the Tailored DVD group whose anxiety data were missing. Excludes 6 participants in the Tailored DVD + Patient Navigation group whose anxiety data were missing. Excludes 4 participants in the Usual Care group whose anxiety data were missing.

Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy

Participants who completed a colonoscopy within 12 months of the baseline interview per EMR documentation and self-reported their satisfaction with the experience during the 6 or 9 month post-baseline interview. Excludes 6 participants in the Tailored DVD group whose satisfaction data were missing. Excludes 6 participants in the Tailored DVD + Patient Navigation group whose satisfaction data were missing. Excludes 4 participants in the Usual Care group whose satisfaction data were missing.

Satisfaction With Colonoscopy Experience

Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation

CRC screening self-reported during the 6 or 9 month follow-up telephone interview. Excludes 1 participant in Tailored DVD group due to data being collected outside of interview window. Excludes 1 participant in Usual Care group due to data being contradictory/invalid.

Participants Who Self-Reported Completing CRC Screening

Colonoscopy completed per self-report during the 6 or 9 month follow-up telephone interview. Excludes 1 participant in Tailored DVD group due to data being collected outside of interview window. Excludes 1 participant in Usual Care group due to data being contradictory/invalid.

Participants Who Self-Reported Completing a Colonoscopy

FIT completed per self-report during the 6 or 9 month follow-up telephone interview. Excludes 1 participant in Tailored DVD group due to data being collected outside of interview window. Excludes 1 participant in Usual Care group due to data being contradictory/invalid.

Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT)

Enrolled participants who completed the 6 month post-baseline interview. Excludes 1 participant in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in the Usual Care group due to the data being contradictory/invalid.

Change in Knowledge of CRC and Screening

Enrolled participants who completed the 6 month post-baseline interview. Excludes 7 participants in the Tailored DVD group whose data were missing. Excludes 5 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 8 participants in the Usual Care group whose data were missing and 1 participant in the Usual Care group due to the data being contradictory/invalid.

Change in Perceived Risk for CRC

Participants who self-reported their colonoscopy-related anxiety during the 6 month post-baseline interview, regardless of their colonoscopy completion status. Excludes 1 participant in the Tailored DVD group whose data was missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group due to data being missing for 1 participant and data being contradictory/invalid for 1 participant.

Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy

Enrolled participants who completed the 6 month post-baseline interview. Excludes 3 participants in the Tailored DVD group whose data was missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data was missing. Excludes 2 participants in the Usual Care group due to data being missing for 1 participant and data being contradictory/invalid for 1 participant.

Change in Perceived Benefits of CRC Screening by Colonoscopy

Enrolled participants who completed the 6 month post-baseline interview. Excludes 1 participant in the Tailored DVD group whose data were missing. Excludes 2 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 1 participant in Usual Care group due to data being contradictory/invalid.

Change in Perceived Barriers to CRC Screening by Colonoscopy

Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy

Enrolled participants who completed the 6 month post-baseline interview. Excludes 6 participants in the Tailored DVD group whose data were missing. Excludes 5 participants in the Tailored DVD + Patient Navigation group whose data were missing. Excludes 2 participants in the Usual Care group whose data were missing and 1 participant in Usual Care group due to data being contradictory/invalid.

Change in Perceived Benefits of CRC Screening by FIT

Change in Perceived Barriers to CRC Screening by FIT

Change in Perceived Self-Efficacy for CRC Screening by FIT

Baseline Interview With Randomization

Tailored DVD Intervention Given

Patient Navigation Intervention Given

6 Month Post-Baseline Interview

9 Month Post-Baseline Interview

The group is to include at least 1000 individuals who are at high risk for the development of cancer. Risk is assessed through the completion of a clinical history questionnaire. Examples of such subjects include those with known hereditary cancer syndrome pathogenic variants without a diagnosis of cancer, with significant family history of breast, ovarian, colon, or lung cancer or melanoma, or another strong history of cancer but no prior molecular diagnosis, heavy smokers or those exposed to carcinogens and mutagens. The individuals who meet criteria for inclusion will undergo cell-free DNA isolation and circulating-tumor DNA (ctDNA) analysis for the detection of genetic mutations associated with the possible development of a malignancy.

Cell-free DNA (cfDNA) is isolated from a blood plasma sample and tested for the presence of 96 specific well-described mutations in 9 cancer driver genes. The presence of more than 2 copies of a mutation may indicate the presence of a malignancy. Follow up with the subject's physician would be needed for an examination and any additional testing that the physician wants to perform to further assess for the development of cancer.

ctDNA Analysis for the Detection of Genetic Mutations

Glenn Braunstein, MD

Anja Kammesheidt, PhD

Pathway Genomics Corporation (Pathway Genomics), a San Diego, California company, is involved in the development and validation of new molecular diagnostic assays for the analysis of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) found in the plasma-derived DNA (cell-free DNA or cfDNA) in order to identify specific variants (mutations) in cancer driver genes. The purpose of testing for mutations in ctDNA is to detect and monitor cancer. All cells shed DNA into the bloodstream. Finding cancer-associated mutations in the cfDNA may lead to early detection of cancer in an otherwise apparently healthy (i.e. asymptomatic) individual or may allow the healthcare provider to more effectively monitor and treat a known cancer patient. The analysis is performed using a polymerase chain reaction (PCR)-based methodology where oligonucleotides are designed to target specific mutations in designated genes of interest followed by next generation deep sequencing of the amplified targets. Evaluation of the performance of these assays for screening for cancer in asymptomatic subjects is essential for the clinical validation of the use of these assays. The specific aim of this protocol is to obtain relevant human blood samples from individual subjects at higher than average risk for the development of cancer due to age, heredity, or environmental or toxic exposures for use in the statistical analysis of this method as an adjunct screening test for the potential presence of cancer.

The objectives of this study are to obtain human blood samples from asymptomatic subjects who have never been diagnosed with cancer, but who may be at increased risk for cancer due to heredity, exposures, age, or family history to assess the validity of screening healthy but at risk patients for cancer via analysis of ctDNA.

Specifically, the blood specimens will be collected from individuals who have responded to a self-administered health questionnaire that screens for higher risk of contracting cancer. Each participant will be asked to provide a 30 ml blood sample to be drawn by a primary care provider (PCP) or licensed phlebotomist. The specimens collected during the study may also be used in the research and development of new or modified molecular genetics assays. The results of these studies will be used to further the understanding of the use of ctDNA for the detection and monitoring of cancer in humans.

The blood samples are collected in blood collection tubes (BCT) called Cell-Free DNA BCT® manufactured by Streck and intended for collection, stabilization and transportation of cell-free plasma DNA. This device also stabilizes and preserves cellular genomic DNA present in nucleated blood cells and circulating epithelial cells (tumor cells) found in whole blood. This product has not been cleared by the U.S. Food and Drug Administration for In Vitro Diagnostic use and is labeled by Streck for research use only. Under the Clinical Laboratory Improvement Amendments (CLIA) regulations, laboratories are authorized to validate and use, as part of a laboratory-developed test (LDT), devices that have not been cleared or approved by the FDA. Pathway Genomics validated the CancerInterceptTM Detect molecular analysis system with the Streck tubes, in accordance with CLIA.

Once the specimen has been collected and sent to Pathway by the physician or the phlebotomist who collects the samples, all other processing and testing are conducted by Pathway laboratory personnel. The analysis begins with the separation of the plasma from the rest of the blood sample. cfDNA will then be isolated from each sample. The quantity of cfDNA is measured and then the sample is amplified via PCR for next generation sequencing. The results of the sequencing will then be analyzed for the presence of one or more of the 96 mutations analyzed in this assay. The data are then reviewed and a report will be generated.

Whole blood will be obtained, the plasma sample separated for the isolation of cell-free DNA, and the sample that may be stored will be excess plasma as well as potentially DNA from the buffy coat.

Utility of Plasma Circulating Tumor DNA (ctDNA) in Asymptomatic Subjects for the Detection of Neoplastic Disease

A cohort of 1000 or more individuals who are at high risk for the development of cancer will be tested for the presence of 96 well-described mutations in 9 cancer driver genes via ctDNA analysis. The number of individuals with one or more of the 96 assayed mutations will be assessed.

Among the cohort of subjects enrolled in the study in whom one or more of the 96 ctDNA mutations are detected, the number of copies per analyzed plasma sample will be calculated.

Within the samples found to contain one or more ctDNA mutation, the percentage of ctDNA within the total amount of cfDNA will be calculated.

The 1000 or more individuals in the study will be followed for 1 to 5 years to assess for the development of a malignancy. Special attention will be paid to the cohort who have initial assays indicating the presence of ctDNA. The subjects may be retested over time to show changing levels of ctDNA. Their own physicians will guide any follow up studies such as imaging or other laboratory testing. The test is designed as a means of case finding for cancer among individuals with high risk for development of cancer.

Pathway Genomics

Imidacloprid

Patients view decision aid without personalized message and whose providers do not receive the personalized message.

Patients view decision aid with personalized message and whose providers do not receive the personalized message.

Patient view decision aid without the personalized message and whose providers receive the personalized message.

Patients view decision aid with the personalized message and whose providers receive the personalized message.

The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.

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Utility of Plasma Circulating Tumor DNA (ctDNA) in Asymptomatic Subjects for the Detection of Neoplastic Disease	NCT02612350	Mutation Neoplasms	ctDNA Analysis ...	18 Years -	Pathway Genomics
Utility of Plasma Circulating Tumor DNA (ctDNA) in Asymptomatic Subjects for the Detection of Neoplastic Disease	NCT02612350	Mutation Neoplasms	ctDNA Analysis ...	18 Years -	Pathway Genomics
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Evidence-informed Choice for Women Participating in Mammography Screening	NCT01335906	Early Detection...	Information	45 Years - 69 Years	Andaluz Health Service
Validation of Serum Assays for the Diagnosis of Gastritis	NCT05883345	Cancer Screenin...	Serum blood tes...	18 Years - 99 Years	Konkuk University Medical Center
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