Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants in the Intervention group receive a brochure with their personalized risk score for colorectal cancer and screening recommendations (FIT or colonoscopy) corresponding to their risk level.

Participants in the Usual care group receive the standard brochure designed by the Vaud screening program. This brochure recommends screening to all individuals beginning at age 50 and presents both FIT and colonoscopy as equal options.

Provide participants with information about their personalized risk for colorectal cancer and appropriate screening recommendations to facilitate their screening option choice.

Intervention brochure

Provide participants with general information about options for colorectal cancer screening.

Control brochure

Kevin Selby, MD, MAS

The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.

The secondary objectives:

* Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
* Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.

The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of participants' risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to a participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.

This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.

Colorectal cancer (CRC) can be effectively prevented by screening. Risk to develop CRC within 15 years is related to increasing age, sex, family history, and lifestyle and, thus, can vary from \<1% to \>15%.

Fecal immunochemical test (FIT) and colonoscopy are the most widely used screening tests. Colonoscopy is the most accurate test, but is related to risks of bleeding and perforation. Colonoscopy resources are limited, and high uptake of screening colonoscopy for low-risk individuals can cause long wait times for those with CRC symptoms or positive FIT. FIT is less costly can be done at home without preparation and, if done regularly, prevents most CRC mortality, especially in moderate and low-risk individuals. To offer the screening options with a reasonable risk-benefit balance, FIT should be recommended to individuals at low (\<3% to develop CRC in 15 years) and moderate (3-6%) risk, and colonoscopy to those at high (\>6%) risk.

The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.

The secondary objectives:

* Assess the feasibility of a subsequent larger RCT designed to detect a change in clinical outcomes;
* Explore the impact of psychological factors (perceived susceptibility for CRC, perceived benefits from and barriers to screening) on appropriate screening uptake and participation rates.

The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of the participant's risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.

This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.

Colorectal Cancer Screening Based on Predicted Risk

Protocol Title: Colorectal Cancer Screening Decisions Based on Predicted Risk: the PREcision ScreENing Randomized Controlled Trial (PRESENT)

Upon publication of the primary results, the data that support the findings of this study will be available from the corresponding author upon reasonable request.

Proportion who completed screening test appropriate to risk level. For low risk (\<3% 15-yr CRC risk), completing a FIT. For intermediate risk (3-6%15-yr CRC risk), completing a FIT, completing a colonoscopy, or having a colonoscopy appointment. For high risk (\>6% 15-yr CRC risk), completing a colonoscopy or having a colonoscopy appointment.

Proportion who completed any CRC screening test (FIT, colonoscopy, colonoscopy appointment, CT colonography, blood test, etc.

Proportion of those invited with completed paper or electronic consent

Proportion of those who returned the baseline questionnaire who are eligible for the Vaud screening program (i.e. not up-to-date with screening, not in colonoscopy surveillance, no personal CRC history, etc.)

Mean anxiety score using adapted questions from a standardized questionnaire (STAI Fr)

Proportion of study participants who consent and whose screening status are obtained from the Vaud CRC screening program

Proportion of study participants who consent and whose cancer status are obtained from the Vaud tumor registry. Long time frame chosen given considerable delay in updating the tumor registry and interest in cancer outcomes several years after measurement of primary outcome.

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Rare Diseases

Familial Colorectal Cancer

Patients with Colorectal Cancer and their First Degree Relatives (FDRs).

Questionnaire regarding awareness of screening tests and attitudes toward colorectal cancer screening, taking 30-45 minutes to complete.

Questionnaire

Susan Peterson, MPH,PHD

The goal of this psychosocial research study is to learn about the knowledge, beliefs, and attitudes that people have toward screening for colorectal cancer. Another goal is to study how families communicate about colorectal cancer risk and colorectal cancer screening, with each other and with health care providers.

Objectives:

1. To evaluate psychosocial and external factors influencing colorectal cancer (CRC) patients' communication with their first-degree relatives (FDRs) about CRC risk and screening information.

   Using measures of knowledge, health beliefs and behavior, family closeness, openness and motivation to discuss CRC and screening, distress, provider support and background variables (sociodemographics, access to care, and medical history), we will conduct a cross-sectional study to evaluate factors influencing CRC patients' communication about CRC risk and screening information to their FDRs.
2. To evaluate psychosocial and external factors associated with CRC screening behavior among first-degree relatives of CRC patients.

Using measures of knowledge, health beliefs and behavior, family closeness and subjective norms, distress, provider interactions, benefits/barriers, and background variables (race/ethnicity, sociodemographics, access to care, and medical history), we will conduct a cross-sectional study of FDRs of CRC patients recruited under Aim 1 to evaluate factors associated with CRC screening behavior (specifically, colonoscopy adherence).

You will be interviewed by a member of the study staff over the telephone. You will be asked about your awareness of screening tests for colorectal cancer, and your attitudes toward colorectal cancer screening. You also will also be asked about your family's past use of these screening tests, and how you discuss colorectal cancer risk and screening with your family and health care providers. Some demographic information also will be collected (such as your age or marital status). The questionnaire will take between 30 and 45 minutes to complete.

Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified.

This is an investigational study. Up to 325 colorectal cancer patients and their close relatives may take part in the study. All will be enrolled MD Anderson.

Screening for Familial Colorectal Cancer (CRC) Patients

Screening and Risk Communication for First Degree Relatives of Colorectal Cancer Patients

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Uterine Cervical Neoplasms

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The pap-smear test result is sent by letter directly to the women. Women in need of follow up are in the letter recommended to contact their general practitioner.

In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.

Test result sent by letter

Test result conveyed by general practitioners

Peter Vedsted

Flemming Bro

Berit S Andersen

Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.

Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.

However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.

Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:

1. A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
2. Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).

The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.

Follow-up of Abnormal and Inadequate Smear-test Results

Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.

The proportion of women followed up will be calculated as cumulated incidence proportions according to four timeframes (undesirable early, as recommended, late, very late), and be compared by relative risks. The results will be presented in totals and separately depending on the test result (normal/inadequate/Bethesda classification 2001/HPV).

The two randomisation groups will be compared with respect to contacts with general practitioner after the smear test the first days, weeks, months after the general practitioner is notified of the screening result.

University of Aarhus

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Syndrome

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hereditary Breast and Ovarian Cancer Syndrome

Colorectal Neoplasms, Hereditary Nonpolyposis

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.

Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.

Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to

Online modality

Optional genetic counselor follow-up over the telephone

Genetic counselor follow-up

Catharine Wang, PhD

Efforts to examine the utility of alternate modalities for genetic results disclosure has widespread implications for how precision medicine research might yield direct health benefits for study participants. This study will examine the efficacy of an online self-guided program to return genetic results to a racial minority cohort population. Study results will provide empirical evidence on the effectiveness of alternate modalities for genetic results return, inform ongoing efforts to establish scalable approaches for effective return of genetic research results, and increase access to personal health information among African American women.

This study is a randomized controlled trial (RCT) within the Black Women's Health Study (BWHS) to test alternate communication modalities for results disclosure. The BWHS is an ongoing prospective cohort study of 59,000 self-identified black women from across the United States who have been followed since 1995. Targeted sequencing of over 4000 women within the cohort for BRCA1/2 and other known or suspected high and moderate penetrance genes opens up the possibility of returning breast cancer genetic results to BWHS participants and examining the clinical utility of genetic results return. The primary aim of the proposed research project is to compare the efficacy of two communication modalities for returning breast cancer genetic research results to African American women: 1) a conventional modality that entails telephone disclosure by a licensed genetic counselor, and 2) an online self-guided modality that entails returning results directly to participants, with optional genetic counselor follow-up via telephone. Secondary aims of this study will examine 1) moderators of the intervention impact and 2) psychosocial, sociodemographic, and clinical predictors of result uptake. This study is uniquely situated to provide critical empirical evidence on the effectiveness of alternate models for genetic results return and provide further insight into the factors influencing uptake of genetic information among African American women.

Scalable Communication Modalities for Returning Genetic Research Results

Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women

Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.

Knowledge about breast cancer genetics will be assessed using an investigator derived questionnaire consisting of 16 items. Higher scores out of ten are associated with more genetics knowledge.

Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.

Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.

Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.

Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.

University of Washington

MGH Institute of Health Professions

National Institute on Minority Health and Health Disparities (NIMHD)

Boston University

Herbal and Botanical

All Drugs and Chemicals

Cola

Subjects view:

1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.

Subjects view:

1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.

DA - Quantitative

DA - Verbal

Peter H Schwartz, M.D., Ph.D

Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.

The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.

Information With or Without Numbers For Optimizing Reasoning About Medical Decisions

Describing the Comparative Effectiveness of Colorectal Cancer Screening Tests: The Impact of Quantitative Information

Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test within 6 months of enrollment, based on documentation in the participants' electronic health record. If a patient completed both screening tests and the colonoscopy was a follow-up to a positive FIT, they were considered having completed a FIT only. If the FIT was negative and the patient still had a colonoscopy, they were considered to have completed both tests.

Multiple choice question assessing subject's intention in getting a CRC screening test in the next 6 months. The response options were: 5=Definitely, 4=Probably, 3=May or may not, 2=Probably not, and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome.

Multiple choice questions assessing subject's perception of how likely they are to get colon cancer in the next 5 years, in the next 10 years, and sometime during their lifetime. Each had response options: 4=very likely, 3=somewhat likely, 2=somewhat unlikely, and 1=very unlikely. The mean of the 3 questions was calculated (each combined score has a range of 1 to 4) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk which is a better outcome.

Assessed separately for colonoscopy (4 questions) and FIT (4 questions), using items drawn from validated scales for measuring benefits and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with higher values meaning perceived benefits increased which is a better outcome.

Assessed separately for colonoscopy (11 questions) and FIT (9 questions), using items drawn from validated scales for measuring barriers and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with lower values meaning perceived barriers decreased which is a better outcome.

Qualitative knowledge is assessed with five multiple choice and five true/false questions regarding general information (including risk factors, screening test options, and test frequency) of CRC and CRC screening. Knowledge scores were derived by summing correct responses to the 10 individual knowledge questions (range, 0-10), and change from baseline was calculated using the knowledge score at post-intervention minus the knowledge score at baseline. The range for change could be 0 to 10 with higher values meaning an increase in knowledge which is a better outcome.

Decision conflict is assessed using the16-item Decision Conflict Scale. Scores will range from 0 (low decision conflict) to 100 (high decision conflict). Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome.

Subjective numeracy was determined using the Subjective Numeracy Scale (SNS), a validated instrument that involves 8 Likert-type questions regarding the participant's preference for or dislike of numeric information and their perception of their ability to understand it. Each item has a six-point response option from 1-6. The higher the number, the higher the subjective numeracy. All participants were divided into two groups: above (high numeracy) and below (low numeracy) the median for their total subjective numeracy score.

Patient-Centered Outcomes Research Institute

Indiana University

Assistant Professor of Medicine

Subjects view:

1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.

DA - Quantitative

Quantitative

Subjects view:

1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.

DA - Verbal

Verbal

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Education

Relationship

Employed?

Health Insurance?

Insurance Lapse over past 12 months?

Self-reported health status at baseline

Income Level (yearly)

Income Level Subjective

The analysis population includes only those participants who completed the study. There were 20 participants in each arm that were withdrawn; these participant's data were not included in the analysis.

Peter H. Schwartz, M.D., Ph.D.

All participants who agreed to having their electronic health record (EHR) checked by the researchers. There were 12 participants in the Verbal arm and 4 participants in the Quantitative arm who would not agree for their EHRs to be checked by the researchers; therefore, assessment of uptake was not performed with those participants.

Colorectal Cancer (CRC) Screening Completion

All participants with both baseline and post-intervention responses to CRC screening intent items. There were 2 participants in each arm who did not respond to at least one of the intent items.

Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention

All participants with baseline (T0) and post-intervention (T1) perceived risk items. Missing responses were not used.

Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention

Colonoscopy Benefits

FIT Benefits

Participants who completed both the baseline and post-intervention benefit questions. For colonoscopy, it was 324 in Verbal and 332 in Quantitative. For FIT, it was 320 in Verbal and 330 in Quantitative.

Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention

Colonoscopy Barriers

FIT Barriers

Participants who completed both the baseline and post-intervention barrier questions. For colonoscopy, it was 322 in Verbal and 330 in Quantitative. For FIT, it was 321 in Verbal and 327 in Quantitative.

Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention

All participants who completed at least 7 knowledge questions at both baseline (T0) and post-intervention (T1).

Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention

All participants with at least 11 responses to the 16-item Decision Conflict Scale at both baseline (T0) and post-intervention (T1).

Decision Conflict: Change in Conflict From Baseline to Post-intervention

Subjects who completed the Subjective Numeracy Scale.

Number of Patients With High and Low Subjective Numeracy

Subjects view:

1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing verbal information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.

Decision Aid (DA) - Verbal

Subjects view:

1. A computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy and stool testing. Includes excerpts from a video from the American Cancer Society.
2. Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting and dying from CRC, (b) the reduction in morbidity and mortality provided by colonoscopy and stool tests, (c) the sensitivity of colonoscopy and stool tests for finding cancer, (d) the false negative values of colonoscopy and stool tests for finding cancer, (e) the risk of heavy bleeding or colon injury from colonoscopy, and (f) the chance of having a positive stool test.

Decision Aid (DA) - Quantitative

Overall Study

Infections

Respiratory Tract (Lung and Bronchial) Diseases

COVID-19

Leadership, providers, and staff at the study team's affiliated health systems.

Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems.

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.

Semi-structured interviews-Patients

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.

Semi-structured interviews-Health system

Karen K Schmidt, MSN

The rate of screening for colorectal cancer (CRC) in the U.S. remains low (under 65%), meaning that thousands of people die of colorectal cancer unnecessarily. Colorectal cancer screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). Screening rates go up when patients consider all these tests, not just colonoscopy. Informing patients about their options for CRC screening could produce higher quality decisions, improve the match between patient preferences and tests performed, and increase uptake of CRC screening. Decision aids (DAs) are a promising tool for accomplishing this goal. Also, precision CRC prevention - providing information about an individual's specific risk for CRC - has great promise to increase uptake and improve decision making.

Unfortunately, the COVID-19 pandemic is causing severe challenges to providing CRC screening and other prevention services. Health systems are trying to adapt, but these efforts have only begun and are poorly understood. Moreover, patient perceptions of disease risk and risk from COVID-19 are unknown.

The study team will engage with the leadership, staff, and providers in the study team's partner healthcare systems, to identify facilitators and barriers to implementing patient decision aids and provider notifications as well as cancer risk assessment tools, for colorectal cancer screening, and for other evidence-based cancer screening during the COVID pandemic and, potentially, after the conclusion of the pandemic.

At the conclusion of the study, the investigators will have extensive information regarding how best to provide decision aids through an electronic health record (EHR) portal, with or without personalized information, and to deliver provider notifications, which can guide broader implementation.

The study will involve interviews with staff and providers at the study team's partner healthcare systems to identify facilitators and barriers to implementing decision aids and provider notifications for colorectal cancer screening.

Also, the investigators will interview patients to identify perceptions of prevention during the COVID-19 pandemic including risk perception and barriers to screening, perceptions of risk from both the pandemic and disease, and patient cancer screening and risk prevention behaviors engaged in or postponed during the pandemic and patient rationales for their decisions. This part of the study will suggest potentially promising approaches for providing prevention and disease management during the COVID-19 pandemic.

Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months

Semi-structured interviews with health system leadership, providers, and staff

Semi-structured interviews with primary care patients

Principal Investigator

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer Screening Based on Predicted Risk	NCT05357508	Colorectal Canc...	Intervention br... Control brochur...	50 Years - 69 Years	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Screening for Familial Colorectal Cancer (CRC) Patients	NCT00632515	Colorectal Canc...	Questionnaire	- 60 Years	M.D. Anderson Cancer Center
Follow-up of Abnormal and Inadequate Smear-test Results	NCT02002468	Carcinoma in Si...	Test result sen... Test result con...	23 Years -	University of Aarhus
Scalable Communication Modalities for Returning Genetic Research Results	NCT04407611	Hereditary Brea... Lynch Syndrome	Online modality Genetic counsel...	40 Years -	Boston University
Information With or Without Numbers For Optimizing Reasoning About Medical Decisions	NCT02477553	Colorectal Canc...	DA - Quantitati... DA - Verbal	50 Years - 75 Years	Indiana University
Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation	NCT04683744	Colorectal Canc...	Semi-structured... Semi-structured...	18 Years -	Indiana University
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening	NCT04683731	Cancer Screenin...	Decision aid wi... Decision aid wi... Provider notifi... Provider notifi...	50 Years - 75 Years	Indiana University
Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program	NCT03884868	Colo-rectal Can...	Iconographies t...	50 Years - 69 Years	Corporacion Parc Tauli
Smoking Cessation in Cancer Patients	NCT01685723	Cancer Smoking Cessati...	Counseling grou... General support...	18 Years -	The University of Hong Kong
Risk Education and Assessment for Cancer Heredity	NCT01346761	Breast Cancer Ovarian Cancer Genetic Predisp...	Telephone Genet... In-Person Genet...	25 Years - 74 Years	University of Utah
Risk Education and Assessment for Cancer Heredity	NCT01346761	Breast Cancer Ovarian Cancer Genetic Predisp...	Telephone Genet... In-Person Genet...	25 Years - 74 Years	University of Utah
Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation	NCT04683744	Colorectal Canc...	Semi-structured... Semi-structured...	18 Years -	Indiana University

Spots Global Cancer Trial Database for risk communication