Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Receives decision aid intervention that encompasses balance sheets, navigation, audio files, and interaction -- Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION)

An interactive mHealth decision aid that includes immediate and over time quality of life (QL) graphical summaries for advanced prostate cancer patients to enhance informed, shared decision making and will also be used to assess the CPNs' role in the decision-making process.

CHAMPION

Randy A Jones, PhD,RN,FAAN

Jane Gildersleeve, MSN

Jennifer Wenzel, PhD,RN,FAAN

Richard Brown, PhD

Prostate cancer is a commonly diagnosed cancer, and is the second leading cause of cancer deaths among men in the U.S. The subgroup of men with advanced prostate cancer is particularly vulnerable to difficult choices for treatment because of the nature of their disease and having limited options. This study will test the use of an innovative Registered Nurse-Community Patient Navigator team delivered interactive mHealth decision aid for patients with advanced prostate cancer to help facilitate informed shared decisions about anti-cancer treatment that affects their quality of life.

Many patients with advanced prostate cancer along with their decision partners/ proxies (DPP) struggle with complex treatment decisions, such as when to start, change, or stop cancer directed treatment. Despite the utility of decision aids (DAs) to address decisional conflict, little is known about treatment decision-making for advanced cancers. The study's primary aim is to test the effects of a theory- based mHealth DA (CHAMPION) administered by Registered Nurse (RN)-Community Patient Navigator (CPN) teams to advanced prostate cancer patients and decision partners/proxies on the following outcomes: less decisional conflict/uncertainty, higher psychosocial quality of life domain (HRQL-PSY), and less regret at the time of making an anti-cancer treatment decision. The secondary aim is to evaluate the CPN role in delivery of the mHealth DA (CHAMPION) from the patients' and decision partners/proxies' perspective. Preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans versus Others in the primary and secondary aims will also be explored. This mixed-methods population-based randomized controlled trial will gather data from 158 patient/DPP pairs at three sites: University of Virginia Emily Couric Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, and Virginia Commonwealth University Massey Cancer Center. The pretest/posttest design will measure a time period that includes three single-event decisions over the course of their cancer-directed treatment; and a qualitative retrospective design will allow exploring the experiences of both patients and their DPPs separately in an interview at the completion of the study. Stratification by race (African-American and Caucasian/Other) and decision point (starting vs. changing vs. stopping anticancer treatment) will be used. There will be two groups: the control (enhanced usual care \[EUC\]) group and the decision intervention (DI) group. The DI group will receive an interactive 7-component cognitive-behavioral skills mHealth program (DA) with a RN-CPN team, primarily focusing on decision-making during cancer treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with DI. The primary outcome measures are 1) decisional conflict (uncertainty), 2) decisional regret, 3) HRQL-PSY, and 4) decision-making participation preference. Generalized linear models will be used for data analysis for the quantitative component, and qualitative evaluation of the intervention will be conducted to capture each pair's experience of the CHAMPION intervention. This innovative mHealth DA delivered by a CPN is expected to increase acceptability and the uptake of both the DA and the technology components. This addresses several NIH/NINR innovative questions, through the use of information technology to promote health-related decision-making for providers and patients, examining patient outcomes for improvement in healthcare, as well as to engage and support individuals such as extended family, lay coaches, etc. to augment provider care and recommendations.

Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth

demonstrate less decisional conflict/uncertainty, higher QL (HRQL-PSY domain) and less regret at the time of making an anti-cancer treatment decision

evaluate community patient navigator role in delivery of decision aid

Johns Hopkins University

Virginia Commonwealth University

University of Virginia

Associate Professor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

This group receives a baseline questionnaire before their screening invitation. Respondents are included, and those receiving a screening reminder receive the decision aid.

At least three months after their screening invitation the included citizens (baseline questionnaire respondents) will receive a follow-up questionnaire.

This group receives a baseline questionnaire before their screening invitation. Respondents are included. At least three months after their screening invitation, baseline questionnaire respondents will receive a follow-up questionnaire.

A group of people already invited for colorectal cancer screening. This group receives a questionnaire at least three months after their screening invitation. Respondents are included in the study.

The DA is an online tool. The web-based design opens up possibilities to feature more advanced functions, e.g. questions for the participant during the process, and a summary of answers at the end. The DA is tailored to lower educational attainment citizens, and is designed to embrace different information needs in the target population, ranging from a desire to receive a clear recommendation and a minimum of information to the desire to receive full information and make a personalized choice.

Decision aid

Pernille Gabel, MD PhD Fel.

The aim of the trial is to test the effect of a web-based decision aid (DA) on colorectal cancer (CRC) knowledge, decisional conflict, participation rate, and informed choice (evaluated based on knowledge, attitudes and actual participation).

The study includes three study arms. Citizens to be recruited are identified from the Danish Civil Registration System based on residence (Central Denmark Region), age (50-74 years old), and month of birth. A random sample of 15,000 citizens born in December (invited for CRC screening through October/November/December 2017) (study arm 1+2) and 5,000 citizens born in October (invited for CRC screening in January/February 2017) (study arm 3) is identified.

Citizens in study arm 1+2 will receive a baseline questionnaire assessing knowledge, attitudes, worry, and health literacy. Non respondents will receive one reminder after two weeks and after four weeks non-respondents will receive a phone call, offering them to fill out the questionnaire via the phone. Baseline questionnaire respondents are included in the study, and will be randomized into two study arms (intervention group and control group).

Citizens in the intervention group will be identified in the screening IT system. Date of screening invitation and screening reminder (citizens who do not return a stool sample within 45 days of the screening invitation) is retrieved. Citizens receiving a screening reminder will receive a link for the DA. Follow-up questionnaire will be sent to all included citizens in study-arm 1+2 three months after the last screening invitation has been sent out. Citizens have six weeks to respond to the questionnaire.

Study arm 3 is a historic cohort. The citizens receive only one questionnaire at the same time as the baseline questionnaires are sent out to the intervention and control groups. The citizens are included if they respond to the questionnaire within six weeks. Questionnaire reminders are sent out at two and four weeks.

Data on screening invitation date, screening reminder date, returning a stool sample and result will be retrieved from the screening IT system for all included citizens (Study arm 1-3). Lastly, data from Statistics Denmark (on socio-demographic and socio-economic factors) will be included.

Study setting The Danish national colorectal cancer (CRC) screening programme was implemented in Denmark in March 2014. All citizens aged 50-74 years are invited to take up CRC screening biennially, however, the first prevalence round is carried out during a four year period (2014-2017). During the this period, citizens are invited according to month of birth, except citizens aged 49 who are invited just before they turn 50 and citizens turning 75 who are invited prior to their 75th birthday, if they were not invited earlier in the program.

Politically and organisationally the CRC screening programme is nationally directed, but the administrative responsibility is placed within the five regions in Denmark. The Department of Public Health Programmes is responsible for the administration of the CRC screening programme in the Central Denmark Region (CDR).

The CDR has 1.3 million citizens (23% of the total population) of which roughly 390 000 citizens are 50-74 years of age. The citizens receive an invitation, containing a screening kit. The screening test (collection of a stool sample) is performed in the citizen's own home. The stool sample is sent to the clinical biochemical department at the hospital. If the citizens do not return a stool sample within 45 days after receiving the invitation, a screening reminder is received. Citizens, who still do not return a stool sample, are automatically referred to the next screening round, and will receive another invitation two years later. Citizens with a negative test are automatically referred to the next screening round. Citizens with a positive test are invited to have a colonoscopy.

Since 2010, national digitisation has occurred in Denmark. Hence, communication to and from Danish authorities occur via digital mail, in the public email platform E-Boks. Danish residents are obliged to order a digital signature (NemID) which is used as a shared log-in for E-boks, public and private online self-services, and online banking. Only disabled citizens (e.g. physical or cognitive impairment) or citizens unable to satisfactorily identify themselves (e.g. migrants with no permanent resident permit) can be exempted from ordering a NemID. As of May 2016 more than 5 million Danish citizens (87.5% of the entire population including children) have access to E-boks. Exemption from digital communication has been granted to 9.8% of Danish Residents aged 45-74 years.

All letters in the CRC screening programme are sent by digital mail, except from invitation letters, which contains a screening kit and are sent by conventional mail. Citizens exempt from digital communication receive conventional letters via a remote printing system.

All invitations and reminders in the screening program are sent out based on lists generated in the administrative CRC screening program IT system, which is linked to the daily updated Danish Civil Registration System, in which all Danish citizens are registered with unique civil registration numbers (CRN) assigned at birth or at immigration. The department of public health programmes is administratively responsible for the screening program IT system.

Study flow The study population will be identified based on data extraction from the Danish Civil Registration System. 10 000 citizens 50-74 years old, living in the Central Denmark Region born in December (invited for CRC screening through October/November/December 2017) and 5 000 citizens 50-74 years old, living in the Central Denmark Region born in October (invited for CRC screening in January/February 2017) are identified.

The 10 000 citizens born in December comprise the population to be randomized (study arm 1 and 2). This group of citizens will receive a baseline questionnaire at the beginning of the study period (before receiving screening invitations). Non-respondents receive a questionnaire reminder after two weeks. After four weeks a telephone call is made offering filling out the questionnaire via telephone. Respondents (at six weeks after receiving the questionnaire) are included in the study and randomized into two groups (intervention and control group). All included citizens are monitored in the screening program IT system, in order to identify date of screening invitation and date of screening reminder. Citizens in study arm one (intervention group) receive a decision aid (DA) on the same day as the screening reminder or the next day. Both groups receive a follow-up questionnaire three months after the date of invitation for the last citizen invited in the study population. Questionnaire reminders are sent out at two and four weeks, and deadline for questionnaire response will be after six weeks.

The 5 000 citizens born in October comprise a historic cohort of citizens invited to CRC screening. This population receives only one questionnaire 3-4 months after they received their screening invitations. In this survey reminders will be sent out at two and four weeks. Respondents (at six weeks) will be included in the study.

All contact with the study participants in this study will occur via digital communication or by postal mail via remote printing system. Hence all questionnaires, survey reminders, and DAs will be sent out first via digital mail. However, it is crucial to reach a high questionnaire participation rate in order to obtain generalizable results. The aim is to reach a survey participation rate of no less than 50% for baseline and 80% for follow-up.

When questionnaire data has been collected, date of screening invitation and screening reminder will be collected from the screening program IT system along with the date of test registration laboratory and the test result.

Questionnaire data and IT system data are both uploaded to Statistics Denmark, where socio-demographic data are appended for the data management and data analysis.

Materials Three different questionnaires will be administered in this trial: The baseline questionnaire, the follow-up questionnaire, and the questionnaire for the historic cohort. The questionnaires comprise five different scales. The worry scale, the knowledge scale, the attitudes scale, the decisional conflict scale, and the health literacy scale, developed by the European Union consortium (HLS-EU-Q16).

The DA is an online tool. The web-based design opens up possibilities to feature more advanced functions, e.g. questions for the participant during the process, and a summary of answers at the end. Further a web-based design has lower running costs, and can be provided as a link via the E-boks platform. The development of the DA took place in five steps: (1) scoping of the DA; (2) formation of the steering group (the research group); (3) Design phase, in which the prototype was developed based on previous research by the research group; (4) Alpha testing, including citizens and experts evaluating design and usability and a peer review by experts and citizens, evaluating content and usability; (5) Beta testing, including citizens, evaluating feasibility, comprehensibility and usability.

The development took place as an iterative process, in which the DA was revise between each step based on the experiences gained from the previous step.

Background data on educational level, family income, occupation, marital status, and ethnicity will be obtained from Statistics Denmark when questionnaire data have been collected.

Statistical methods All statistical analyses are going to be carried out in Stata/SE 14 (STATACorp LP, College Station, Texas, USA), stratifying according to gender. All estimates will be presented with 95% confidence intervals, and all analyses will be carried out on a 5% significance level. Since citizens with lower educational attainment (LEA) are the target group of this study, all citizens with medium or higher educational attainment will be excluded from the statistical analyses.

Pearson's chi-square test will be used to test differences in demographic characteristic distribution between respondents and non-respondents as well as between the study arms in order to test whether the randomisation succeeds.

Differences in distributions of responses to the outcomes (informed choice, yes/no; Adequate knowledge, yes/no; mean level of decisional conflict; mean level of decisional support; mean level of effectiveness of decision made; mean level of worries; and participation, yes/no) in the study arms are being analysed using the independent sample t test for continuous variables and Pearson's chi-square test for categorical variables. Further, the relative risk (RR) will be estimated for all dichotomous outcomes using a 2x2 table with study arm 2 and historic study arm as the reference, respectively.

If randomisation does not succeed in producing groups with similar baseline characteristics, a logistic regression will be completed for categorical outcomes and a linear regression for continuous outcomes in order to estimate an adjusted odds ratio (OR) as a value to be interpreted as a RR.

All analyses will be conducted as intention to treat (ITT) analyses, in which all LEA citizens will remain in the study arms to which they were first assigned.

Power calculations Every month 9 900 citizens are invited to participate in CRC screening in the CDR. On average, 47% of these (4 600) do not return a stool sample within 45 days, and they receive a screening reminder. It is expected that at least 1 200 (26% of the population, according to Statistics Denmark) have LEA. Power calculations (considering a 5% significance level and an 80% statistical power) based on being able to detect expected differences of the outcomes of 22% (proportion making an informed choice), 14% (proportion having a positive attitude towards CRC screening), 16% (proportion participating in CRC screening) and 2.4 (difference in mean score of knowledge) between the groups (as observed in previous studies) indicate that 200 citizens with LEA needs to be included in every group thereby a total of 770 citizens who receive a screening reminder. Analyses are stratified by gender; therefore the study population is doubled to 1 540 participants in every group, so that adequate power is retained to assess the effect of the DA in both genders.

With an expected participation rate of 58% for baseline questionnaire (study arm 1+2) and an expected participation rate of 80% in the follow-up questionnaire in study arms 1 and 2, 10 000 citizens who will be invited for screening (5 000 in each study arm and hence an allocation ratio of 1:1) are included. In the historic study arm a 50% participation rate is expected (two written reminders, no telephone calls), hence we 5 000 citizens, who will be invited for screening, are included.

The LEAD trial is conducted as a two arm, randomised controlled trial nested into a population-based, organized CRC screening programme conducted in the Central Denmark Region. Citizens who are scheduled to be invited for CRC screening within the study period will be randomly allocated into one two study arms. Further, a historic study arm will be included, in order to be able to assess the effect of receiving the baseline questionnaire:

1. To receive the DA along with the screening reminder and to receive both baseline and follow-up questionnaires (intervention group)
2. To receive both baseline and follow-up questionnaires (control group)
3. To receive a questionnaire comprisng scales from both baseline and follow-up questionnaires (historic cohort)

Regardless of study arm, all citizens receive standard CRC screening information material according to the CRC screening program procedures.

Since baseline questionnaire is filled out before randomizasion, and citizens will know if they receive the DA or not, participants will not be masked.

No care providers are involved in the screening program in the phases we study (invitation, reminder, and stool sample), hence no masking in this groups.

The outcomes are assessed via questionnaire data or from registries (Statistics Denmark and the screening IT system), and no masking is necessary in neither investigators nor outcomes assessors.

The Effect of a Colorectal Cancer Screening Decision Aid Tailored to Lower Educational Attainment Citizens

The Effect of a Colorectal Cancer Screening Decision Aid Tailored for People With Lower Educational Attainment in the Central Denmark Region on Colorectal Cancer Knowledge and Colorectal Cancer Screening Attitude and Participation Rate

No individual patient data are to be shared with other researchers.

Assessed using questionnaire. Six items yielding a scale score between 0 and 100 %. Continous variable.

Assessed using questionnaire. Four items. Scores between 7 and 28. Continuous variable.

Binary outcome (yes/no), retrieved from screening IT system.

Assessed in questionnaire. Three items. Individually scored.

Decisional conflict scale. Questionnaire. 16 items. score 0-100 points.

HLS-EU-Q16 scale. Questionnaire. 16 items. Score 0-16.

Socio-demographic outcome, Statistics Denmark. LEA (≤10 years of education) and medium or high educational attainment (\>10 years of education)

Socio-demographic outcome, Statistics Denmark.The categories will be lower tertile, middle tertile, and upper tertile.

Socio-demographic outcome, Statistics Denmark. Employed, Self-employed chief executive, Unemployed/receiving benefits, Retired, Social welfare recipients, and Others.

Socio-demographic outcome, Statistics Denmark. Married/cohabitant or single/widow

Socio-demographic outcome, Statistics Denmark. Danish, Immigrant (Western origin), and Immigrant (non-western origin)

University of Aarhus

M.D. PhD Fellow

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening.

Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening.

The intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening.

Lung Cancer Screening Decision Aid with Incidental Findings Information

The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.

Lung Cancer Screening Decision Aid without Incidental Findings Information

Stephen Clark, MD

Daniel Jonas, MD, MPH

This online randomized controlled trial seeks to determine if inclusion of incidental findings information in a lung cancer screening decision aid affects screening intent among screening-eligible individuals. Participants will view either a decision aid with incidental findings information or without and indicate their intent to pursue lung cancer screening.

Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen among participants.

Effect of Incidental Findings Information on Lung Cancer Screening Intent

Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial

This will be assessed by a survey item where participants indicate their response to a statement of whether they plan to pursue lung cancer screening, with answer choices being strongly agree, agree, disagree and strongly disagree. Comparison between the intervention and control groups will be made.

Lung cancer screening knowledge tested by 6 multiple choice questions on facts of the benefit and harms of screening. The questions will be answered before and after participants watch a lung cancer screening decision aid. Scores will be determined by the number of correct answers for questions.

Participants will rate (Likert 1-5 scale with 1 being less important and 5 being more important) 6 lung cancer screening benefits and harms on importance to them.

Participants will rank six lung cancer screening benefits and harms.

Participants will rank six lung cancer screening benefits and harms, including one on incidental findings. Comparison of mean ranking will be made between the intervention and control groups.

UNC Cecil G. Sheps Center for Health Services Research

UNC Lineberger Comprehensive Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The BEFORE decision aid will be available for use on the RUBY communication portals (Twitter, Facebook and study portal)

Data will be collected 6 weeks before the implementation of the BEFORE decision aid in RUBY sites to establish a baseline

Evaluate more intensive strategies to promote use of the BEFORE decision aid through:

1. We will advertise the availability of the BEFORE decision aid with posters placed in clinic areas at each RUBY site, and will have small handouts available to be distributed in clinic.
2. We will conduct an educational intervention describing and promoting the use of the BEFORE decision aid and general oncofertility information to nurses and support staff at each RUBY site. This will include an optional 1hr informational webinar, direct outreach and training of nurses/support staff on the use of the tool.

Data will be collected after the BEFORE decision aid has been implemented in each RUBY site regarding the recommendation of fertility resources, most useful/least useful tool, and use of the BEFORE decision aid.

Implementation of the BEFORE decision aid in clinical practice

BEFORE decision aid

Implementation of the BEFORE decision aid on RUBY communication portals

Review impact of BEFORE decision aid implementation in clinical practice

Nancy N Baxter, MD, FRCSC, FACS, PhD

Brittany Speller, MSc

Brittany, Speller

May Lynn Quan, MD, MSc, FRCSC

Ellen Warner, MD, FRCPC, FACP, MSc

Adena Scheer, MD, FRCSC, MSc

Erin Kennedy, MD, PhD, FRCSC

Kelly Metcalfe, RN, PhD

Fertility is of great importance to young women with cancer. Concerns about the ability to become pregnant after cancer treatment may influence treatment decisions and fertility decision-making is challenging. Despite these challenges, there is a lack of fertility decision support tools. Our team developed the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aid for young breast cancer patients in Canada. This study aims to evaluate the implementation of the BEFORE decision aid in hospital settings through a stepped wedge cluster randomized trial.

The investigators will conduct a stepped wedge cluster randomized trial to sequentially implement the BEFORE decision aid in clinical settings that are currently recruiting young breast cancer patients for the Reducing the bUrden of Breast cancer in Young women (RUBY) Study (www.womensresearch.ca/ruby-study/).

For this trial 24 participating RUBY sites were grouped into 14 clusters (1 to 3 sites per cluster). The decision aid intervention will be sequentially rolled out over the course of 48 weeks to all clusters. None of the clusters will be switched from control to intervention during the first 6 weeks of the study to establish a baseline. Then two clusters will move from the control to the intervention every 6 weeks (called a 'step'). There will be 7 steps total during the study period. At the end of the 7th step all clusters (i.e., participating RUBY sites) will have received the decision aid intervention. The time-point of when the clusters will be switched from control to intervention will be randomized.

The data collection includes obtaining secondary data collected as part of the RUBY study from all patient participants who were enrolled in RUBY during the study period. The primary outcome is the number of patients reporting that fertility tools were recommended to them, based on RUBY participant responses to a 3-month fertility questionnaire. The investigators hypothesizes that following the implementation of the decision aid intervention a 20% difference will be observed, from 10% in the control to 30% in the intervention, in the number of patients who report that someone in their care team recommended a fertility tool.

BEFORE Decision Aid Implementation Study

Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid - A Stepped Wedge Cluster Randomized Trial

Number of visits to the BEFORE decision aid

Length of visits to the BEFORE decision aid

Most visited page on the BEFORE decision aid

Least visited page on the BEFORE decision aid

Number of people who downloaded the paper BEFORE decision aid

BEFORE decision aid user location by province in Canada

Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis

Specific provider who recommended the BEFORE decision aid to the patient

How the patient first learned about the aid (e.g, by the poster or their care provider)

Patient satisfaction with the way they found out about the BEFORE decision aid

Applied Health Research Centre

Canadian Breast Cancer Foundation

Canadian Institutes of Health Research (CIHR)

Unity Health Toronto

Chief of General Surgery, Scientist

Immune System Diseases

Hypersensitivity

Bowel cancer screening decision aid, DVD and Question Prompt List (QPL)

Bowel cancer screening decision with DVD only

Australian Government Bowel Cancer Screening consumer information booklet

A decision aid developed for adults with low levels of education and literacy making decisions about bowel cancer screening, using faecal occult blood test (FOBT)

Bowel cancer screening decision aid

A consumer booklet developed by the Australian Government for people taking part in the National Bowel Cancer Screening program

Australian Government Bowel Cancer Screening booklet

Kirsten J McCaffery, PhD

Sian K Smith, BSc (Hons)

McCaffery J Kirsten, PhD

The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.

Several countries have recently implemented national bowel cancer screening programs. To ensure equal access to screening, consumer information is needed to suit adults ranging in literacy level. Decision aids (DAs) are tools which have been developed to assist patients and consumers make informed health decisions and encourage active participation in health care decisions. Their use in a wide range of clinical settings has increased dramatically. However, most DAs are highly dependent upon high levels of literacy and numeracy, and few have been developed for low literacy populations.

This primary aims of this study are to assess the impact of the decision aid on (1) the proportion of adults who make an informed choice about bowel cancer screening (using faecal occult blood test) and, (2) the level of involvement in screening decisions among adults with lower levels of education and literacy.

There are three secondary aims of the study. First, to measure the effect of the decision support tool on decisional conflict, decision satisfaction, anxiety, and bowel cancer worry. Second, to identify participant's screening interest, intentions and behavior. Thirdly, we will explore participant's reactions towards the information materials they receive and whether the doctor influenced their screening decision.

Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening

A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy

National Health and Medical Research Council, Australia

University of Sydney

Dr Kirsten McCaffery

alert from SEBASTIAN decision support system

SEBASTIAN is an example of a clinical decision support technology that supports the latest, service-based architectural approach to CDSS implementation. Developed at Duke University, SEBASTIAN is a clinical decision support Web service whose interface is now the basis of the HL7 Decision Support Service draft standard SEBASTIAN places a standardized interface in front of clinical decision support knowledge modules and makes only limited demands on how relevant patient data are collected or on how decision support inferences are communicated to end-users

SEBASTIAN Clinical Decision Support System (CDSS)

Ana M Gomez, MD

Damian A Borbolla, MD

Clinical decision support has been shown to improve the performance of screening tests; however, few studies have documented direct clinical benefit resulting from the increased screening promoted by clinical decision support systems.

The purpose of this study was to determine if a standards-based, sophisticated decision support system could not only promote additional breast cancer screening, but also detect significantly more breast cancer

Breast cancer is the most common female cancer. In the United States, the second most common cause of cancer death in women, and the main cause of death in women ages 45 to 55 years old. The U.S. Preventive Services Task Force recommends screening mammography, with or without clinical breast examination, every one to two years among women aged 50 to 69 years old.

Recent research has shown that health care delivered in industrialized nations often falls short of optimal, evidence based care. US adults receive only about half of recommended care. To address these deficiencies in care, health-care organizations are increasingly turning to clinical decision support systems. A clinical decision-support system is any computer program designed to help health-care professionals to make clinical decisions. In a sense, any computer system that deals with clinical data or knowledge is intended to provide decision support.

Examples include manual or computer based systems that attach care reminders to the charts of patients needing specific preventive care services and computerized physician order entry systems that provide patient-specific recommendations as part of the order entry process. Such systems have been shown to improve prescribing practices, reduce serious medication errors, enhance the delivery of preventive care services, and improve adherence to recommended care standards.

The aim of this study is to show the efficacy of a decision-support system as a strategy for improving the performance of the mammography care process and the detection of significantly more breast cancer.

Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer

New Breast Neoplasms Diagnosis (Incident cases from biopsy reports). Breast Neoplasms are stored in the institutional Clinical Data Repository. The diagnosis are automatically codified using a terminology server that use SNOMED-CT as reference terminology

Number of patient with breast cancer screening due that received the order to perform the study (mammography). This information will be record through the clinical data repository every time that a provider order a screening test to each of the patients involve in the study

Duke University

Hospital Italiano de Buenos Aires

Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") AND the DVD decision aid ("Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer"), which provides instruction and recommendations on how to participate in shared decision making with one's physician.

Eligible participants receive the written decision aid ("Making the Choice: Deciding What to Do About Early Stage Prostate Cancer") alone.

The decision aid, "Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer" is a DVD modeling patient communication strategies. The DVD includes vignettes with actors depicting patient-physician discussions of prostate cancer treatments. In these vignettes, the patient models communication strategies designed to facilitate patient activation.

DVD Decision Aid

A written decision aid entitled "Making the Choice: Deciding What to Do About Early Stage Prostate Cancer" that describes treatment options for early stage prostate cancer.

Written decision aid

Angela T Fagerlin, PhD

This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:

* increase patients' perceptions of the importance of their preferences to their decision making
* increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists
* increase patients' actual engagement with their physician during the clinical encounter
* increase the concordance between patient decision making preferences and actual decision making outcomes
* increase long term satisfaction with decision on type of treatment selected
* increase patient satisfaction with their decision and the decision making process
* influence patient perception of his physician (e.g., trust) and of the diagnosis visit

Testing Decision Aids About Early Stage Prostate Cancer

Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

National Cancer Institute (NCI)

University of Michigan

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Colorectal Neoplasms, Hereditary Nonpolyposis

Syndrome

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Familial Colorectal Cancer

* Patients and clinicians have access to a website with information on familial colorectal cancer risk; a risk assessment tool and decision aids
* Clinicians receive the guidelines and a risk communication tool, as well as education

Implementation aids

Control

Nicoline Hoogerbrugge, MD, PhD

Rosella PMG Hermens, PhD

The aim of this study is to improve clinicians' calculation, interpretation and communication of familial colorectal cancer risk, as well as patients' risk perception and uptake of referral for genetic counselling or for surveillance by colonoscopy for their relatives at risk.

Regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (CRC) in patients at increased familial CRC risk. Currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. In 2008, a national multidisciplinary evidence-based guideline on familial and hereditary CRC was launched in the Netherlands. Clinicians have new tasks in familial CRC risk calculation, interpretation and communication. A clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen Dutch hospitals to determine the most cost effective way to implement these new guidelines.

Surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. Patients and clinicians in the intervention group will receive an additional intervention strategy.

The effect evaluation is done by assessing the number of CRC patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. The actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. The costs of the implementation procedure will be determined by means of a cost evaluation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth	NCT03327103	Decision Suppor...	CHAMPION	18 Years -	University of Virginia
The Effect of a Colorectal Cancer Screening Decision Aid Tailored to Lower Educational Attainment Citizens	NCT03253822	Decision Making Knowledge, Atti...	Decision aid	50 Years - 74 Years	University of Aarhus
The Effect of a Colorectal Cancer Screening Decision Aid Tailored to Lower Educational Attainment Citizens	NCT03253822	Decision Making Knowledge, Atti...	Decision aid	50 Years - 74 Years	University of Aarhus
Effect of Incidental Findings Information on Lung Cancer Screening Intent	NCT04432753	Neoplasm of Lun... Decision Suppor... Mass Screening	Lung Cancer Scr... Lung Cancer Scr...	55 Years - 80 Years	UNC Lineberger Comprehensive Cancer Center
BEFORE Decision Aid Implementation Study	NCT03629509	Decision Suppor... Breast Neoplasm... Young Adult Evaluation Stud...	BEFORE decision... BEFORE decision... BEFORE decision...	18 Years - 40 Years	Unity Health Toronto
Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening	NCT00765869	Colorectal Neop...	Bowel cancer sc... Bowel cancer sc... Australian Gove...	55 Years - 64 Years	University of Sydney
Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer	NCT01336257	Breast Cancer	SEBASTIAN Clini...	50 Years - 69 Years	Hospital Italiano de Buenos Aires
Testing Decision Aids About Early Stage Prostate Cancer	NCT02053389	Prostatic Neopl...	DVD Decision Ai... Written decisio...	18 Years -	University of Michigan
Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening	NCT00765869	Colorectal Neop...	Bowel cancer sc... Bowel cancer sc... Australian Gove...	55 Years - 64 Years	University of Sydney
Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth	NCT03327103	Decision Suppor...	CHAMPION	18 Years -	University of Virginia
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer	NCT00929097	Colorectal Neop...	Implementation ... Control	18 Years - 70 Years	Radboud University Medical Center
Testing Decision Aids About Early Stage Prostate Cancer	NCT02053389	Prostatic Neopl...	DVD Decision Ai... Written decisio...	18 Years -	University of Michigan

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