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

To evaluate the impact of the decision aid intervention (information plus decision aid (IDA) vs. usual care (UC)), and timing of intervention delivery (at Home (pre-screening) vs. in the Clinic (screening day)) on key patient outcome variables of PCa knowledge and decisional satisfaction.

patient decision aid (print-based)

Kathryn L. Taylor, Ph.D.

The primary goal of this study is to develop and evaluate a print-based method of patient education with a decision tool that is designed to provide detailed information about prostate cancer and to clarify patient preferences and values, ultimately assisting men in making an informed screening decision.

In spite of the significant disease burden presented by PCa, the utility of screening asymptomatic men remains controversial, as it has not yet been demonstrated by a randomized trial that early diagnosis and treatment of PCa reduces disease-related mortality. The primary goal of the proposed study is neither to encourage nor discourage PCa screening, but to evaluate a method of patient education that is designed to provide detailed screening and treatment-related information and to clarify patient preferences and values, ultimately assisting men in making an informed screening decision. The target population for this educational intervention will be men who have registered to undergo PCa screening within a free, mass screening program. Although at first this may appear to be an atypical group to target for an educational intervention, we present information suggesting that this population represents a large and uniformed group for whom effective and inexpensive methods of education are of critical importance. We will test the impact of providing men with detailed information and a decision aid vs. usual care information and the impact of the timing of administration of information (a week or more prior to the screening vs. usual care, which is on the day of screening). Participants will include men who register for the annual PCa mass screening programs held at Georgetown University and at Howard University during the 2004 and 2005 screening programs. Following enrollment and the baseline interview, participants will be randomly assigned to one of four groups: 1) Information plus Decision Aid received prior to the scheduled screening date (IDA-home); 2) Information plus Decision Aid received on the day of screening (IDA-clinic); 3) Usual Care information received prior to the scheduled screening date (UC-home); or 4) Usual Care information received on the day of the screening (UC-clinic). Follow-up assessments will be conducted post-screening, post receipt of screening results, and one-year post-intervention, to measure knowledge, decisional conflict, decisional satisfaction, and the actual screening decision. We will utilize a 2 (IDA/UC) X 2 (Home/Clinic) X 2 (AA/white) repeated measures analysis of covariance to assess for group differences on these outcomes. If found to be effective, the long-term goal of this research program is to disseminate this informational decision aid for use in mass screening programs.

Prostate Cancer Screening: Fostering Informed Decisions

National Cancer Institute (NCI)

Georgetown University

Kathryn L. Taylor, PhD, Principal Investigator

Carcinoma

Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.

Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences.

Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences

Educational Intervention

Undergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening

digital rectal examination

15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers

Pre-test administration

Survey will be administered at the end of the program for participants to assess their experience

Survey Administration

PSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines

Prostate-specific antigen measurement

Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding

Post test administration

Samir Abraksia, MD

This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.

PRIMARY OBJECTIVES:

(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18

OUTLINE:

Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.

After completion of study, participants are followed up periodically.

Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program

The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation

Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire. The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.

Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.

Case Comprehensive Cancer Center

All participants recruited to the trial will receive the decision aid. This a one-group study with a quasi-experiemental pre/post evaluation design.

All patients recruited to the study will receive the PCSPrep decision aid. There is only 'study arm.' The Clinical Research Coordinator (CRC) will provide the patient with an iPad to complete the pre-test, PCSPrep and post-test. Individuals will see the survey questions on screen and will hear accompanying audio through headsets. Participants will: (1) be introduced to PCSPrep and the menu of activities/topics; (2) enter information about themselves for personal tailoring (e.g., risk factors); (3) participate in a values-clarification exercise to rate the personal importance of varied courses of action (i.e., pros/cons of PCS); (4) receive a printout with an individualized plan for discussing PCS with their primary care provider.

Prostate Cancer Screening Decision Aid

Jennifer D Allen, SCD

This is a multicenter study that involves research on screening for prostate cancer. This study pilot tests a culturally appropriate decision aid (DA) for African American (AA) men that will empower them to take part in decision-making regarding prostate cancer screening (PCS). The Prostate Cancer Screening Preparation (PCSPrep) tool was designed with intend to be delivered in primary care settings with attention to patient/provider interaction. Funding for this study comes from the National Institute of Health/National Cancer Institute (1R21CA178296).

STUDY AIMS AIM 1: Among AA men ages 45-70, estimate the impact of PCSPrep on primary outcomes: (a) knowledge; (b) confidence in ability to make informed decisions and communicate with provider; (c) consistency between values \& PCS preferences.

AIM 2: Among primary care providers, to assess secondary outcomes: (a) perceptions regarding patient engagement in SDM; and (b) concordance with patient's ratings of SDM.

AIM 3: Among patients, providers and clinic staff, document the feasibility and acceptability of integrating PCSPrep into primary care practices.

RECRUITMENT \& ENROLLMENT

Primary Care Providers Recruitment:

PCPs eligible to participate will be Emory Health Care practitioners who see at least 20 potentially eligible patients. These PCPs will be sent information from the Investigator Team and Clinic Director explaining the study We will use effective clinician recruitment procedures established in our prior work, including presentations at standing clinician meetings, meeting individually with providers, and being on site to answer questions. Ten PCPs who consent to participate will complete a brief survey following the visit from each of their enrolled patients, and allow these clinical encounters to be audio-recorded. See appendix B for post encounter survey for providers. As is standard in studies involving physicians, a financial incentive will be provided following completion of post-visit data collection for each patient when allowable and not in conflict with federal regulations. In the case of the VA hospital system, providers are not allowed to take financial incentives for research, so they will not receive this. Following the visit from each of their enrolled patients, providers will respond to a brief, online survey about the extent to which they involved the patient in the SDM process, and their perceptions regarding the quality of the communication about PCS. Total provider time in the study is estimated at 120 minutes (up to 15 enrolled patients x 10 minutes per post-encounter survey + 20 minutes of informed consent discussions).

Patient Recruitment and Enrollment:

The study will enroll AA men (age 45-70) who have not undergone prostate cancer screening (PCS) in the prior 3 years. Additional eligibility criteria will include: (1) self-reported AA race/ethnicity; (2) age 45-70; (3) English speaking. Exclusion criteria will include: personal history of prostate cancer (CaP), life expectancy of \<10 years as determined by the primary care provider (PCP); or serious psychiatric conditions or cognitive impairment. Identification and recruitment of patients will be conducted by the Clinical Research Associate (CRA) under supervision of the investigators and in partnership with PCP's who opt to participate. Electronic medical records (EMR) and scheduling systems may be used to identify potentially eligible men who are scheduled for a non-acute, routine medical visit with a participating PCP during the enrollment period (i.e., Dr. Filson will access his EMR account and supervise all viewing by the CRA). See appendix D for Patient recruitment letter. Two weeks prior to a scheduled visit, eligible men will be mailed study information and an opt-out card informing them that they will be contacted by phone. Men who do not opt out will be called by the CRA, screened for eligibility, and provided with information about the study procedures. See appendix E for telephone recruitment script. Men interested in participating will be asked to arrive at the clinic 90 min prior to their scheduled visit to review study information with the CRA, provide informed consent, complete pre- and post-test and post-clinical encounter surveys, and the PSCPrep. The day prior to their scheduled visit, the CRA will call to remind them of their appointment and the opportunity to participate in this study.

INTERVENTION ADMINISTRATION PCSPrep meets the International Patient Decision Aid Standards for high quality DAs, and adheres to best practices for culturally relevant interventions.Learning objectives for participants include to: (1) understand that there is a decision to be made; (2) identify their preferred role in decision-making; (3) obtain accurate, unbiased information about benefits, limitations and potential harms of screening; (4) understand personal risk of CaP; (5) clarify one's values as they relate to the potential screening outcomes; (6) seek input from significant others, if desired; (7) develop skills for communicating with provider; (8) elicit input from provider; and (9) develop a plan for action based on desired course of action.

PCSPrep uses an audiovisual and touch-screen format on an iPad to simplify use for individuals with limited literacy and/or computer skills. It is comprised of a series of modules on the web in which professional actors describe the decision-making process, communication with a provider, and discussion of PCS. Content is delivered by actors presented as physicians who answer call-in questions in a format modeled on a health-focused television show, based on focus group feedback. Questions and discussion are presented to normalize the idea that decisions are based on individual values and preferences.

Addressing Prostate Cancer Information Disparities With eHealth Technology

Data Sharing Plan agreement between Tufts University, Emory University, and Dana-Farber Cancer Institute

Confidence in ones ability to gather requisite information and to make an informed decision

Knowledge regarding the potential benefits, harms and limitations of prostate cancer screening

Consistency between decision about screening and stated values regarding the pros and cons of screening

Tufts University

Associate Professor

The I Can PIC website will be provided to participants randomized to the experimental/intervention group.

Participants randomized to the attention control group will be provided a link to a website developed by the American Cancer Society Cancer Action Network.

Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.

I Can PIC

Mary C Politi, PhD

The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.

In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors. The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance. In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants. The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network. Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences. The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.

Improving Cancer Patients' Insurance Choices

Supporting Cancer Survivors' Health Insurance Marketplace Decisions

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions).

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

Participants will be asked what health insurance plan they would choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

Participants will be asked what health insurance plan they choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

American Cancer Society, Inc.

Washington University School of Medicine

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Access to LuCaS, a web-based lung cancer screening decision aid

Access to NCI website on lung cancer screening

Web-based Lung Cancer Screening Decision Aid

LuCaS Decision Aid

NCI Website

Jamie L Studts, PhD

Margaret M Byrne, PhD

This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking.

The proposed project will develop an innovative web-based decision aid (DA) to improve decision making for lung cancer screening (LCS) among individuals at high risk for lung cancer due to cigarette smoking. Recent National Lung Screening Trial (NLST) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest X-ray among individuals at high lung cancer risk. Given that lung cancer is the leading cause of cancer death in the United States with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in LCS. However, LCS carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. Further, it is unknown whether LCS would reduce lung cancer mortality among individuals who smoke but do not meet NLST eligibility criteria. Therefore, there is currently no clear best choice for whether a given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, previous data indicate that individuals who do undergo LCS rarely have a thorough understanding of the risks or benefits.

To address this rapidly emerging public health challenge, this research has developed a web-based decision aid (DA) to facilitate informed decision making regarding LCS in individuals at high risk for lung cancer (i.e., cigarette smokers), and will assess feasibility of DA administration and proposed methods for conducting a future randomized clinical trial (RCT) of DA effectiveness. The content of the DA will be based on the investigators previous studies exploring LCS decision making and other recent research.

The specific aim of the currently proposed research are to conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. Investigators will recruit participants to assess feasibility of: 1) delivering the DA intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT.

Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Number of individuals who make email or telephone contact to inquire about the study per week

Number of individuals who are determined to be study eligible

Number of individuals who provide informed consent per week

Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website

Percentage of participants who would recommend LuCaS Choices or National Cancer Institute (NCI) website to others who want to learn more about lung cancer screening

Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website

Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website

Percentage of participants who complete the POST survey

Percentage of participants who complete the FOL survey

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostate Cancer Screening: Fostering Informed Decisions	NCT00196807	Prostate Cancer	patient decisio...	40 Years - 70 Years	Georgetown University
Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program	NCT02419846	Prostate Carcin...	Educational Int... digital rectal ... Pre-test admini... Survey Administ... Prostate-specif... Post test admin...	19 Years -	Case Comprehensive Cancer Center
Addressing Prostate Cancer Information Disparities With eHealth Technology	NCT02787434	Prostate Neopla...	Prostate Cancer...	45 Years - 70 Years	Tufts University
Improving Cancer Patients' Insurance Choices	NCT03592433	Cancer Health Literacy Health Insuranc... Health Services... Informed Decisi...	I Can PIC	18 Years - 64 Years	Washington University School of Medicine
Development and Feasibility Testing of a Lung Cancer Screening Decision Aid	NCT02790866	Lung Neoplasms	LuCaS Decision ... NCI Website	40 Years -	University of Kentucky
Improving Cancer Patients' Insurance Choices	NCT03592433	Cancer Health Literacy Health Insuranc... Health Services... Informed Decisi...	I Can PIC	18 Years - 64 Years	Washington University School of Medicine
Addressing Prostate Cancer Information Disparities With eHealth Technology	NCT02787434	Prostate Neopla...	Prostate Cancer...	45 Years - 70 Years	Tufts University

Spots Global Cancer Trial Database for informed decision making