Patients receive pre-test genetic counseling and, if relevant, post-test counseling for a negative result from an automated genetics education assistant.

Patients receive standard counseling from a genetic counselor.

The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone.

Patient Directed Standard of Care

Kimberly Kaphingst, PhD

The purpose of this study is to compare the uptake of genetic testing among patients randomized with two different models of genetic services delivery (a patient-directed model and an enhanced standard of care model) and examine whether the impact on uptake differs by race/ethnicity and rurality. This study will also compare the effect of these delivery models on adherence to cancer prevention and screening recommendations and other patient responses.

Patient Screening: A comprehensive screening algorithm will identify patients with family history data in various sections of the electronic health record (EHR) who meet current genetic testing criteria. Randomization to study arm (Enhanced Standard of Care or Patient-Directed Standard of Care) will be at the level of the primary care clinic.

Enhanced Standard of Care Patients will be offered the opportunity to schedule a pre-test genetic counseling visit. Pre-test counseling includes review of the family history, risk assessment, discussion of the purpose of genetic testing and possible outcomes, implications for insurance coverage, costs, and assessment of psychosocial needs. Patients can opt to proceed with genetic testing during this session. All test results are returned by a genetic counselor by phone or in person based on the patient preference. A copy of the results and a letter with tailored screening recommendations are returned to the primary care provider and patient via the patient portal or mail.

Patient-Directed Standard of Care The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal of the electronic health record. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU (New York University). Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone. A copy of the results and a letter with tailored screening recommendations will be provided to the patient and primary care provider via the patient portal.

All patients will be offered the option to schedule follow-up appointments in the genetics clinics.

Genetic Testing:

Genetic testing will be performed by Clinical Laboratory Improvement Act (CLIA)- certified, commercial laboratories based on standard clinical practice. Genetic testing will not be required to participate in the research questionnaires.

Research Procedures:

Two follow-up questionnaires will be sent via the patient portal following interaction with genetic counseling:

i. Questionnaire #1: For participant who chose to receive genetic testing, a questionnaire will be sent approximately 4 weeks after their genetic results are returned. Through this questionnaire investigators will assess cognitive (i.e., recall, comprehension, uncertainty, risk perceptions), affective (i.e., test-related distress, positive reactions, decision regret), communication responses (i.e., family, provider), experience with genetic counseling, and sociodemographic characteristics. For those who chose not to test, a questionnaire will be sent approximately 4 weeks after last genetic service contact. In this questionnaire investigators will assess experience with genetic counseling, reason for not testing, decision regret, risk perceptions, and sociodemographic characteristics including numeracy.

ii. Questionnaire #2: A questionnaire will be administered approximately 12 months after last genetic services contact. For those who chose to test, this questionnaire will ask about discussion of their test results with their primary care provider, family members, or others, and self-reported use of cancer screenings. For those who decide not to receive genetic testing, investigators will assess the self-reported use of cancer screenings, whether genetic testing was pursued at another time or through another source, communication with family members, and whether other relatives had received testing.

For any participants who would like to complete questionnaires by telephone, a genetic counseling assistant or research coordinator will administer the questionnaire. Calls will be digitally recorded to allow for analysis of comprehension. Each questionnaire will take about 15 minutes to complete. Participants may also complete the questionnaires by mail if they choose.

In addition to the questionnaires, investigators will examine screenings, care or health procedures related to genetic services recorded in the electronic health record to determine if an impact is made because of participation in genetic services.

Broadening the Reach, Impact, and Delivery of Genetic Services

Percentage of patients who decide to receive genetic testing

Percentage of patients who decide to receive genetic counseling

Adherence to cancer screening and prevention recommendations given by genetic counselor

New York University

University of Utah

Professor

A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.

Check Yourself - Oncology

Tyler G Ketterl, MD, MS

The purpose of this study is to modify an existing Seattle Children's Hospital investigator-developed, patient-centered, electronic health assessment (eHA) called "Check Yourself" for AYAs with cancer. The investigators will then evaluate the new eHA prototype for feasibility and acceptability among AYAs with cancer and their oncology providers.

Unmet needs among Adolescents and Young Adults (AYAs) with cancer translate to poor physical and psychosocial outcomes. This is particularly true when it comes to AYA sexual health. Our team has found that intimate relationships and risky health behaviors are common among AYAs during their cancer experience, that oncology clinicians rarely ask about these behaviors, and that AYAs rarely volunteer to share these behaviors. As a result, AYAs with cancer are deprived of the surveillance, anticipatory guidance, and normative support participants would have received if participants were well. Currently there is no standard screening process for risk behaviors and the recommended psychosocial screening for AYAs in the SCH oncology clinic setting. To address this problem, the investigators propose to adapt a validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.

The purpose of this study is to modify an existing Seattle Children's Hospital investigator-developed, patient-centered, electronic health assessment (eHA) for AYAs with cancer. The investigators will then evaluate the new eHA prototype for feasibility and acceptability among AYAs with cancer and their oncology providers.

AIM 1. To evaluate the modified eHA program prototype for feasibility, acceptability, and process measures. The investigators will enroll a cohort of N=25 AYAs with cancer and N=10 providers from our institution to "beta-test" the program.

Hypothesis 1: There will be applicable and nonapplicable eHA content for AYAs with cancer in the current electronic health assessment (eHA) tool in addition to content relative to AYAs with cancer that should be developed and added.

Hypothesis 2: AYAs will report that the modified AYA oncology specific eHA is both useful and easy to use. Additionally, oncology providers will report that the eHA tool was useful and positively impacted patient care.

Assessing Health Electronically for Adolescent and Young Adult Oncology

Assessing Health Electronically for Adolescent and Young Adult Oncology (AHEAD)

Determine the feasibility of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the feasibility of intervention measure (FIM) tool survey.

Determine the acceptability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the acceptability of intervention measure (AIM) tool survey.

Determine the usability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the usability of intervention of appropriateness measure (IAM) tool survey.

Tickit Health Solutions

Seattle Children's Hospital

Assistant Professor, Department of Pediatrics

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants received one-on-one breast cancer awareness education; one-on-one monthly Breast Self-Examination (BSE) training; general breast cancer screening recommendations; and general lifestyle modification recommendations

Participants received Standard care as described in the SC arm above in addition to individualized breast cancer risk assessment, individualized breast cancer risk counseling, and lifestyle risk reduction recommendations

Individualized breast cancer risk assessment: The Nigerian Breast Cancer Study (NBCS) absolute risk prediction model was used to predict the 5-year and lifetime breast cancer risks of the participants. The model utilized individual breast cancer risk factors.

Individualized breast cancer risk assessment

Individualized breast cancer risk counselling: The Principal Investigator (PI) and other trained risk counsellors discussed the results of the NBCS risk prediction model with participants and counselled them about the risk of developing breast cancer. The

Individualized breast cancer risk counselling

OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S

OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O

IKEOLUWAPO O. AJAYI, MBBS; PhD

CELIA IMARIA AGWAI, M.P.H; Ph.D.

DEZHENG HUO, PhD

OLUFUNMILAYO OLOPADE, M.D., F.A.C.P

The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are:

* What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology?
* What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria?
* What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria?

Participants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations.

We hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested.

For this study, first-degree female relatives are mothers, sisters, and daughters of BC patients

Nigerian Breast Cancer Risk-Reduction Study

Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria

Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices

Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices

Statistical analysis will be carried out to determined the independent variables predicting BSE

Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening

Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants

Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants

Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants

Lagos State University Teaching Hospital (LASUTH)

Obafemi Awolowo University Teaching Hospital

Lagos University Teaching Hospital (LUTH)

University College Hospital, Ibadan

University of Ibadan

Epidemiologist

Behaviors and Mental Disorders

Alcohol Drinking

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Women who drink seven or more drinks per week

Individuals who eat fewer than five servings of fruits and vegetables per day, on average, based on an NCI screener for fruit and vegetable consumption.

Individuals who exercise (moderate or vigorous intensity) less than 75 minutes per week.

William M Klein, Ph.D.

Background:

- People respond differently when asked about their values. They also respond differently when they learn about how their actions affect their lives and health. Researchers want to learn more about these differences. This can help them improve public health messages.

Objective:

- To see how people respond differently to questions about their values and to information about alcohol and breast cancer.

Eligibility:

Study 1

- Women age 18 and older.

Study 2 \& Study 3

-Women and men aged 18 and older to take part in these studies if they do not meet the US recommendations of eating 5 or more servings of fruits and vegetables per week.

Design:

* This study will take place online.
* Participants will be randomly assigned to a group that will complete a certain task.
* Researchers will ask participants to complete 2 small studies:
* Values Study. Some participants may write briefly about a value that is important to them or to someone they are close to. Some participants will complete a short questionnaire instead of the writing exercise.
* Study 1:

Alcohol and Breast Cancer Study. Participants will read a health message. This will be about the link between alcohol use and increased breast cancer risk. Participants will then answer questions about what they read and their beliefs about alcohol and breast cancer.

-Study 2:

Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption.

-Study 3:

Fruit and Vegetable Consumption and Health Study. Participants will read a health message about the fruit and vegetable consumption. Participants will then answer questions about what they read and their beliefs about fruit and vegetable consumption. Complete a follow-up survey that will be emailed to you through the mTurk system a week after you complete the main study.

* Both studies in either Study 1, Study 2 and Study 3 should take about 30 minutes.

Self-affirmation, a process by which individuals reflect on cherished personal values is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. Thus, we aim to elucidate potential mechanisms underlying the effectiveness of self-affirmation, including self-activation, general affirmation, and domain-specific affirmation. In study 1, female human subjects will be randomly assigned to one of eleven affirmation or self- activation conditions. Following the affirmation or activation task, subjects will read about the documented link between alcohol and breast cancer. Finally, they will be asked a series of questions about their intentions to reduce drinking, their perceived risk of breast cancer, and their worry about breast cancer. Study 2 will replicate study 1, but in a different behavioral domain (physical activity) and a different sample (both males and females who do not meet physical activity recommendations). Study 3 will extend Studies 1 and 2 by examining whether the most effective self-affirmations identified in these studies produce short-term increases in fruit and vegetable consumption. Drawing on previous research, we hypothesize these inductions will be effective to the degree that they involve a self-affirmation, but will not be effective if they involve only other-affirmation or self-activation.

Self-Affirmation: Construct Validity

National Cancer Institute (NCI)

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The standard letter describes the importance of getting screened and instructs recipients how to use the FIT kit for screening at home.

The standard letter is enhanced with language that further emphasizes the risks but also clearly describes how early detection with a test can reduce those risks; it also explains why test kits are being sent to disarm skepticism about the program.

In addition to the enhancements added by the letter with risks, the letter also includes a table comparing FIT kit and colonoscopy. Presenting different screening options allows recipients to make the choice that best suits them. In addition, presenting multiple options increases the chance that recipients get screened in one way or another.

In addition to the enhancements added by the letter with risk, the comparison table includes comparisons of the consequences of getting screened vs. waiting for symptoms to appear.

Recipients receive a letter promoting CRC screening.

Letter

The letter is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by showing the risks of colorectal cancer, while also showing that screening is an achievable means to address those risks.

Loss Frame and Fear Appeals

The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.

Transparency

The pros and cons for screening with FIT kits and colonoscopy are presented. By showing an additional option, the table frames the FIT kit as the default option (since they are included in the mailer). In this situation, inaction is no longer the default option. Changing the default option increases the chance that the FIT kit is used. In addition, another viable alternative is provided (colonoscopy), which still contributes to the goal of the project (getting screened).

Default Effect and Presentation of Alternatives

Comparisons of the mortality rates between screening with FIT kits, colonoscopy, and inaction (waiting for symptoms to appear) are displayed. Inaction is presented as a decoy, which has worse outcomes than either of the screening options. Due to this contrast, the inclusion of the decoy increases the appeal of the other screening options.

Enhanced Fear Appeals and Decoy Effect

Amir Goren, PhD

In this evaluation, 4 different versions of letters are being sent with mailers promoting colorectal cancer screening with an at-home test. The researchers hypothesize that the use of behavioral nudges in the message should lead to increased colorectal cancer screening (either with the at-home test or a colonoscopy).

Colorectal cancer (CRC) is the third most common cancer diagnosed in the US. Mailing fecal immunochemical (FIT) kits to at-risk patients is an effective way of increasing CRC testing uptake, as this test can be done at home and is less intrusive compared to colonoscopies. As part of an existing program, the health system mails FIT kits to eligible patients each year. Although this test needs to be conducted annually, not everyone who receives the test kit returns the kits for processing. In this study, the researchers aim to test different letters with the goal of encouraging the use of FIT kits or scheduling a colonoscopy.

As part of this study, the kits are mailed with everything the patient will need to conduct the test at home and mail a sample back to the hospital. It also includes an introductory letter informing the patient about the program and inviting them to use the kit. The researchers are comparing a standard version of the introductory letter against 3 versions that include different combinations of behavioral nudges, specifically framing effects (loss, default, decoy) and fear appeals.

Participants and providers are not aware of the different letter versions.

Evaluation of Letters Promoting Colorectal Cancer Testing

Evaluation of Letters Enhanced With Behavioral Nudges to Promote Colorectal Cancer Testing Through Fecal Immunochemical Tests or Colonoscopies

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.

Binary variable indicating whether a valid FIT kit was returned for testing

Binary variable indicating whether a colonoscopy was ordered

Binary variable indicating whether a valid FIT kit was returned for testing (a longer time frame allows for late responses)

Binary variable indicating whether a colonoscopy was ordered (a longer time frame allows for late responses)

Binary variable indicating whether the test was positive or negative (if FIT kit was returned)

Binary variable indicating whether the colonoscopy was completed (if colonoscopy was ordered)

Binary variable indicating whether the test was positive or negative (if colonoscopy was completed)

Geisinger Clinic

Program Director, Behavioral Insights Team

Patients in this arm will receive a postcard with words and an image, typical of outreach in prior years, encouraging them to schedule their annual mammograms.

Patients in this arm will receive a letter from the Geisinger Health Plan (on Geisinger letterhead) noting that they're overdue for a mammogram and encouraging them to schedule.

Patients in this arm will receive a call from an auto-dialer with a message noting that they're overdue for a mammogram and encouraging them to schedule.

Patients in this arm will receive a call from a Geisinger Health Plan representative noting that they're overdue for a mammogram and encouraging them to schedule (and helping them schedule if they are interested).

Postcard with phone number to call for help scheduling a mammogram.

Postcard

Letter with phone number to call for help scheduling a mammogram.

Auto-dialer with option to press button for help scheduling a mammogram.

Auto-dialer

Live call offering help scheduling a mammogram.

Live call

Gail Rosenbaum, PhD

The project aims to evaluate four different versions and modalities of interventions encouraging mammogram screening among all eligible women due or overdue for screening. The evaluation will compare among the following forms of outreach to help determine whether (a) live calls are more effective at increasing mammogram screening than other forms of outreach and (b) each form of outreach is more effective than no outreach: (1) a postcard, (2) a letter, (3) an auto-dialer phone message, and (4) a live call from a care gaps team. The interventions will be rolled out over many months, allowing for comparisons of effectiveness against those who have not yet been contacted.

Each intervention will be rolled out to only a subset of the total population each month, such that all patients will receive one of the interventions over the course of 7 months. Active arms will be compared contemporaneously against a passive control group consisting of active arm participants for whom the intervention has not yet begun, as well as a random subset of participants who are excluded before the future intervention begins.

Mammogram Mail- and Phone-based Interventions

Randomized Comparison of Mail- and Phone-based Interventions Promoting Mammogram Screening

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.

Record of completed mammogram (yes/no), for comparing across postcards, letters, and auto-dialer messages

Record of high malignancy risk (yes/no), for comparing across different modalities of outreach

Appointment scheduled for mammogram, among patients visiting Geisinger clinics (yes/no)

Record of completed mammogram (yes/no), for comparing postcards, letters, and auto-dialer messages with live calls

Record of completed mammogram (yes/no), for comparing postcards, letters, auto-dialer messages, and live calls with controls

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Dyslipidemias

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Metabolic Diseases

Lipid Metabolism Disorders

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Chronic Graft Versus Host Disease

Alexandru Irimie, PhD

The continuous increase of the incidence of the thyroid cancer in the last years has taken this neoplasia among the first 4 frequent cancers in the cancer registry of the Institute of Oncology "Prof.Ion Chiricuţă" from Cluj-Napoca (IOCN), with a total number of over 470 new cases per year, added to the other 3700 cases already being in the evidence of the Institute.

The radical treatment brings for a long term a compensated chronic drug induces mYxoedema with it's important side effects. Among these one can find the dislipidemia and the change of the high sensitive C reactive protein (hsCRP) serological value. In the last years, many epidemiological studies have confirmed the fact that the patients with a high serological value of the hsCRP present a higher risk for the coronary disease and heart attack.

Prospective studies developed in european countries and in USA have provided results that are related to the predictive value of the hsCRP determinations over the cardiovascular risk. Thus, hsCRP is an indirect risk factor for the coronary disease. The risk for cardiovascular disease is 2 to 7 times higher at the people with a high level of hsCRP comparing to ones with low levels; the increase of the hsCRP serological value can be determined several years before the clinical debut of the coronary disease.

The screening for this population group with a high risk can introduce in use the prevention of the cardiac pathology and change the approach to the monitoring of the patients with thyroid cancer. A selection protocol will be elaborated for the patients that will withdraw the hormone treatment by using recombinant thyroid stimulating hormone (TSH) or will have personalised monitoring algorithm, with a shortening of the hormone treatment withdrawal.

Although considered a rare type of cancer with an incidence under 6 cases for 100 000 persons, the thyroid carcinoma is the most frequent endocrine tumor. The incidence of this malignant disease has exponentially increased in the last decade, so that many specially centers in the world have focused on a better strategy of diagnosis, of treatment and of monitoring. By applying a suitable multimodal treatment, the prognosis of this disease is excellent, offering the patients a survival rate of over 90% at 10 years. During the monitoring of the disease, the patients are periodically supposed to withdraw the hormone treatment; because of this hormone imbalance, there will be important changes of the metabolism, especially the lipid one. This is the reason why we are preoccupied to increase the quality of life of the patients addicted to a chronic thyroid hormone therapy. The aim of this study is to demonstrate the way in which the lipid profile is influenced and to quantify the cardiovascular risk for the patients radically treated of thyroid cancer, by total thyroidectomy, metabolic irradiation and undergoing a chronic thyroid hormone treatment. Nowadays, Romania is one of the countries in which these patients are supposed to be kept in a iatrogenous myxoedema, the alternative being the recombinant thyroid stimulating hormone. For the patients with the mentioned diagnosis, the lipid profile will be determined and will consist of the following: total serologic cholesterol, cholesterol fractions, triglycerides and C reactive protein highly sensitive (hsCRP). A score for the cardiovascular accident risk will be elaborated. The attempt of classifying in cardiovascular risk groups the patients through the present study, would facilitate the selection of the patients and their access to therapies and modern monitoring strategies.

Lipid Metabolic Status in Thyroid Carcinoma

"Evaluation of Lipid Metabolic Status and of Cardiovascular Risk at Patients With Thyroid Carcinoma, Radically Treated and With Chronic Thyroid Hormonal Substitution"

hsCRP in thyroid hormone withdrwal for patients with thyroid carcinoma radically treated

Iuliu Hatieganu University of Medicine and Pharmacy

Prof. Dr. I. Chiricuta Institute of Oncology

MD, PhD

Web-Based Decision Support

Background:

* Chemoprevention is the use of preventive medications to reduce the risk of breast cancer for women who are at a high risk of developing the disease. Although the treatment has shown effectiveness in preventing cancer development, chemoprevention is notably underutilized even by women who are at a high risk of developing breast cancer.
* Researchers are interested in determining if better decision support mechanisms, such as interactive Web sites, can help to overcome some of the barriers to chemoprevention.

Objectives:

- To develop and test a prototype Web-based module that will provide decision support to women who are considering chemoprevention for breast cancer.

Eligibility:

* Women 35 years of age and older who are at high risk for breast cancer and whose doctor has recommended chemoprevention (either Tamoxifen or Raloxifene), and who have no other history of cancer (apart from non-melanoma skin cancer or precancerous cervical lesions).
* Participants must have a working e-mail address and access to a computer with internet access and a telephone.

Design:

* Participants who are considering chemoprevention will be randomized to a Web-based decision support module or standard care online information resources.
* Participation lasts two months and involves using the online resources provided and filling out questionnaires two times during the study (at the beginning and the end).

The first time will be at the begin of the study.

* No medical treatments are offered as a part of this study

BACKGROUND:

* Breast cancer chemoprevention has been notably underutilized.
* Barriers to integrating breast cancer risk reducing measures include: lack of time, low priority of risk reduction in comparison to treatment, the need to personalize risks and benefits of chemoprevention, and the need for resources/information necessary for women to make informed decisions.
* Access to quality decision support resources to facilitate making informed, preference-sensitive decisions about chemoprevention may provide a mechanism to overcome some of the current barriers to chemoprevention utilization.

OBJECTIVES:

* Develop and refine a web-based patient decision support module for high-risk women making a decision about breast cancer chemoprevention.
* Conduct a randomized study of TACHD decision support versus standard care online information support to evaluate the impact of the chemoprevention module of the TACHD decision support intervention.

ELIGIBILITY:

* Women with no history of cancer other than cervical carcinoma in situ or non-melanoma skin cancer
* High risk for breast cancer based on at least one of the following:

  * Gail score \> 1.67
  * History of atypical hyperplasia (either ductal or lobular)
  * History of lobular carcinoma in situ
  * Documentation of a deleterious BRCA1 or BRCA2 mutation
* Considering a decision about chemoprevention with tamoxifen or raloxifene
* Access to an IBM-compatible or MacIntosh personal computer with broadband Internet access
* Access to an email account
* Access to a telephone
* Aged 35 or older
* Able to communicate in English verbally and in writing

DESIGN:

* The project will be guided by the Cognitive-Social Health Information Processing (CSHIP) model overall, and incorporate the Ottawa Decision Support. Framework (ODSF) in one consistent decision support process.
* Testing of the chemoprevention decision support module will be conducted in a two-group pre- post-test experimental design with 64 at-risk women identified through Fox Chase Risk Assessment Programs and the NCI Clinical Cancer Genetics Program (CCGP) at the National Naval Medical Center (NNMC).
* A process evaluation analysis will assess participants' experiences using TACHD.

Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk

Facilitating Web-Based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants viewed radon and smoking risk information taken from the EPA's pamphlet on the dangers of radon gas exposure.

Participants viewed radon and smoking risk information taken from Idaho's Department of Health and Human Welfare's pamphlet on the dangers of radon gas exposure.

Participants viewed only radon risk information taken from the EPA's pamphlet on the dangers of radon gas exposure.

Participants viewed only radon risk information taken from Idaho's Department of Health and Human Welfare's pamphlet on the dangers of radon gas exposure.

Participants viewed a radon-only message that focused only on the effect of radon on lung-cancer risk.

Participants viewed a radon-and-smoking-isolated message that covered the individual effects of radon and of smoking on lung cancer, but without mentioning their synergistic effect.

Participants viewed a radon-and-smoking-synergistic message that covered the individual effects of radon and of smoking but that also included information about their synergistic effect.

Participants viewed health information detailing the risks of developing lung cancer from exposure to radon gas, smoking, and their synergistic effects. This intervention represents the type of information most commonly presented in radon risk communications.

Radon & Smoking Synergistic

Participants viewed health information detailing the risks of developing lung cancer from radon exposure. No information about the risks for developing lung cancer associated with smoking or its synergistic effect with radon exposure are included.

Radon Only

Participants viewed health information detailing the risks of developing lung cancer from radon exposure and smoking. No information describing the synergistic effects of smoking and radon exposure on lung cancer risk are included.

Radon and Smoking Isolated

Health information modeled after the Environmental Protection Agency's (EPA) pamphlet on radon risk.

Health information modeled after the Idaho Department of Health and Human Welfare's pamphlet on radon risk.

Idaho

Despite a push for tailored messages, health communications are often aimed at, and viewed by, people with varying levels of risk. This project examined-in the context of radon risk messages-whether information relevant to high-risk individuals can have an unintended influence on lower-risk individuals. Specifically, the investigators assessed whether information about lung-cancer risk from smoking reduced concerns about lung-cancer risk from radon among nonsmokers. The investigators hypothesized that non-smokers who read a message that included smoking-relevant information would express less concern about the effects of radon exposure and less interest in testing their home compared to those who read a version in which smoking-relevant information was excluded. Two studies were conducted. Although the investigators did not exclude smokers, the focus was on participants self-identifying as nonsmokers (including never smokers and former smokers).

Despite a push for tailored messages, health communications are often aimed at, and viewed by, people with varying levels of risk. This project examined-in the context of radon risk messages-whether information relevant to high-risk individuals can have an unintended influence on lower-risk individuals. Specifically, the investigators assessed whether information about lung-cancer risk from smoking reduced concerns about lung-cancer risk from radon among nonsmokers. The investigators hypothesized that non-smokers who read a message that included smoking-relevant information would express less concern about the effects of radon exposure and less interest in testing their home compared to those who read a version in which smoking-relevant information was excluded. Two studies were conducted. Although the investigators did not exclude smokers, the focus was on participants self-identifying as nonsmokers (including never smokers and former smokers). Participants in both studies were recruited through Amazon's Mechanical Turk (MTurk). Participants viewed radon messages that varied in the information they communicated about smoking's effect on lung cancer. In Study 1, smoking information was included or excluded from messages assembled from existing radon pamphlets. In Study 2, versions of a new radon message either excluded smoking information, described smoking as a major cause of lung cancer, or also described smoking's synergistic effect with radon on lung cancer risk. After viewing a radon health message, participants completed a variety of measures. Primary measures assessed respondents' anticipated sense of concern and related reactions if they learned that they/their home had been exposed to elevated levels of radon. Other key measures included questions about participants' interest and intention to test their home for radon.

Study 1: Participants randomly assigned to one of two conditions. Study 2: Participants randomly assigned to one of three conditions.

Impact of Smoking Information on Concerns About Radon

De-identified data and guide will be made available to other investigators upon request.

Composite formed from 4 conditional questions assessing concern, perceived impact on risk and comparative risk, and threat--if exposed to radon

Composite formed from 2 questions assessing importance and intention to test home for radon

Single question assessing worry elicited by the health communication material

Three items assessing perceived likelihood of developing lung cancer

Participants given option to leave email address in case they won one of the 20 radon kits being raffled (Study 2).

Participants given option to be presented with more information at the end of the session about testing for radon (Study 2).

Rated how concerned they would be about loved ones if they learned their home had high radon (Study 2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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Assessing Health Electronically for Adolescent and Young Adult Oncology	NCT04484194	Risk Reduction ...	Check Yourself ...	13 Years - 29 Years	Seattle Children's Hospital
Nigerian Breast Cancer Risk-Reduction Study	NCT05834933	Risk Reduction ... Breast Cancer Health Behavior Health Care Uti... Health Knowledg...	Individualized ... Individualized ...	20 Years - 75 Years	University of Ibadan
Self-Affirmation: Construct Validity	NCT02317367	Risk Reduction ...		18 Years -	National Institutes of Health Clinical Center (CC)
Evaluation of Letters Promoting Colorectal Cancer Testing	NCT04548765	Cancer Colorect...	Letter Loss Frame and ... Transparency Default Effect ... Enhanced Fear A...	18 Years -	Geisinger Clinic
Mammogram Mail- and Phone-based Interventions	NCT05853848	Breast Cancer	Postcard Letter Auto-dialer Live call	51 Years - 74 Years	Geisinger Clinic
Self-Affirmation: Construct Validity	NCT02317367	Risk Reduction ...		18 Years -	National Institutes of Health Clinical Center (CC)
Lipid Metabolic Status in Thyroid Carcinoma	NCT01487057	Thyroid Carcino... Dyslipidemias Risk Reduction ... Hormone Replace...		18 Years - 80 Years	Prof. Dr. I. Chiricuta Institute of Oncology
Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk	NCT00906321	High Risk for B... Risk Reduction ...	Web-Based Decis...	35 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Impact of Smoking Information on Concerns About Radon	NCT03499535	Lung Neoplasms Radon Exposure Smoking Intention Risk Reduction ...	Radon & Smoking... Radon Only Radon and Smoki... EPA Idaho	18 Years -	University of Iowa
Nigerian Breast Cancer Risk-Reduction Study	NCT05834933	Risk Reduction ... Breast Cancer Health Behavior Health Care Uti... Health Knowledg...	Individualized ... Individualized ...	20 Years - 75 Years	University of Ibadan

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