Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

David F Penson, MD, MPH

This study will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and incontinence). By figuring out what treatments "work best, in which patients and in whose hands", it will help men with prostate cancer make better decisions regarding their care.

Prostate cancer is the most common solid tumor and the second leading cause of cancer death among American men. While surgery, radiation and observation have all been deemed appropriate for newly diagnosed men, tremendous uncertainty remains regarding the optimal treatment. AHRQ's 2008 evidence report on the comparative effectiveness of therapies for localized prostate cancer concluded that "no one therapy can be considered the preferred treatment for localized prostate cancer due to the limitations in the body of evidence as well as the likely tradeoffs an individual patient must make between estimated treatment effectiveness, necessity and adverse effects." The existing literature is limited by its focus on older therapeutic modalities and failure to control for individual patient characteristics and provider/hospital characteristics that may influence outcomes (quality of care). To fill these evidence gaps, we propose to expand a network of state tumor registries and a national observational disease registry to establish a new population-based cohort of men newly diagnosed with localized prostate cancer. We will prospectively measure key patient-reported outcomes, such as health-related quality of life and side-effects of therapy at diagnosis and 6 and 12 months later. We will also collect detailed medical record information, including clinical data, technical details of the interventions, complications, short-term cancer recurrence rates, and quality-of-care indicators.

By using this approach, we will overcome limitations of the extant literature and achieve the following specific aims:

1. To compare the effectiveness of contemporary surgical and radiation techniques for localized prostate cancer in the cohort described above in terms of the 6- and 12-month patient-reported outcomes, side-effects and complications of treatment.
2. To identify patient level characteristics that may influence comparative effectiveness.
3. To assess how the comparative effectiveness of the various therapies varies by quality of care received.

Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer

Comparative Effectiveness Study of Various Treatments for Localized Prostate Cancer

Sexual, urinary, bowel and hormonal function and bother subscores will be assessed

assessed using PSA levels obtained from medical record review

data collected from patient report and medical record review

Patient-Centered Outcomes Research Institute

Agency for Healthcare Research and Quality (AHRQ)

Louisiana State University Health Sciences Center in New Orleans

University of California, Irvine

University of California, San Francisco

University of Southern California

M.D. Anderson Cancer Center

University of Utah

Emory University

Rutgers Cancer Institute of New Jersey

Vanderbilt University

Professor of Urologic Surgery

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Herbal and Botanical

Imidacloprid

Cola

Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.

Centralized processes to promote guideline-based follow-up.

Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.

Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences.

Choice Strategy outreach invitation includes: 1) invitation letter, 2) option grid comparing FIT and colonoscopy 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

Up to three "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.

Centralized processes to promote guideline-based follow-up.

FIT Screening Strategy

Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.

Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).

Up to three "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.

Centralized processes to promote guideline-based follow-up.

Choice Screening Strategy

Amit Singal, MD, MS

This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program (which does not offer an explicit choice of screening modality). The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system that has a "FIT first" population health screening strategy. All patients will also have access to whatever CRC screening is recommended through usual visit-based care.

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54 CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with screening compared to usual care. Investigators are now conducting a comparative effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based outreach (which does not offer an explicit choice of screening modality (n=8,000.) Randomization will be stratified based on whether or not patients completed a FIT within the prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit and return mailer with prepaid postage, d) telephone reminder calls including one-on-one education, and e) centralized patient navigation for follow-up of abnormal screening results, and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm will receive the same materials described above; however, the educational letter will explain and offer the additional choice of screening by colonoscopy (instead of completing the mailed FIT kit). The mailing will include a low health literacy one-page option grid outlining the pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred but instead emphasize that both are good choices, and the patient should choose the screening option that seems right for them. Patients choosing colonoscopy will be provided a telephone number to schedule the procedure. During scheduling, patients will be triaged by study staff with a structured history and physical form to "direct access" colonoscopy or a pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit using the return envelope with prepaid postage.

Evaluate effect of offering choice of FIT or colonoscopy (n=2,000) compared to FIT alone (n=8,000) on one-time CRC screening completion, repeat screening, and follow-up of abnormal FIT results.

Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening

Comparing the Effect of a Mailed Outreach Intervention Offering Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening Outcomes: A Pragmatic Randomized Control Trial in a Safety Net Health System

Proportion of patients who complete CRC screening with colonoscopy, sigmoidoscopy, or FIT

Proportion of patients who choose FIT versus colonoscopy

Cancer Prevention Research Institute of Texas

Parkland Health and Hospital System

University of Texas Southwestern Medical Center

Associate Professor

* No outreach mailed invitations.
* Ordering of colonoscopy or FIT for screening at the discretion of the primary provider.
* Follow up of abnormal tests and results reporting to the patient at the discretion of primary and specialty providers.

* Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
* Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
* Centralized processes to promote guideline-based follow up.

* Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
* Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
* Centralized processes to promote guideline-based follow up.

Colon Screening Strategy

Amit Singal, MD

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice. Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. The investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits. The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes. The primary measure of harm will be screening non-participation. The primary measure of cost will be cost per-patient effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care and b) the Colo strategy vs. Usual Care for CRC screening.

Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

Parkland-UT Southwestern PROSPR Center: Colon Cancer Screening in a Safety Net: Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies

The primary benefit measure will be defined by the proportion of patients achieving an effective screening "success" defined as:

* Invited to colonoscopy (i.e. colo), responded to invite, determined to be too sick to scope by phone triage and clinical review
* Screening colo completed, no cancer detected
* Screening colo completed, cancer detected, 1st cancer treatment consultation visit completed
* FIT screening completed, test normal, FIT repeated annually for 2 years
* FIT screening completed, test abnormal, failed phone triage for direct scheduling for colo, and after GI clinic visit, determined to be too sick to scope
* FIT screening completed, test abnormal, failed phone triage and clinical review, GI clinic visit, determined to be scopable, colo completed
* FIT screening completed, test abnormal, colo completed, no cancer detected
* FIT screening completed, test abnormal, colo completed, cancer detected, 1st cancer treatment consultation visit completed

The primary measure of harms will be the rate of non-screening because initial test completion is a basic prerequisite for prevention of adverse CRC outcomes by a screening process. It is a readily measurable, basic quality assessment. Processes associated with high rates of non-screening would be expected to result in poor long term CRC outcomes.

The primary measure of costs will be the cost per-patient effectively screened from the health system perspective, with effective screening defined by the proportion of patients achieving an effective screening "success." Follow up time for cost-assessment will start at randomization and end either when a patient reaches an effective screening "success" endpoint, or at the end of the three year-follow up time. This outcome addresses a practical question most health systems will have in assessing our screening strategy: What is the strategy specific cost per-patient effectively screened?

Number of CRCs, advanced adenomas, and adenomas detected.

Number of patients screened, defined by the proportion of patients completing one time FIT or colonoscopy.

Number of CRCs diagnosed based on symptoms/signs rather than screening.

Not achieving an effective screening "success." See definition of effective screening "successes" above.

Post-colonoscopy bleeding or perforation.

Failed colonoscopy due to incomplete bowel prep or inability to reach cecum.

Incremental costs for the FIT and Colo strategies relative to the Usual Care strategy.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

A consecutive sample of clinically localized prostate cancer patients treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy in 18 Spanish hospitals.

It consists on monitoring the cancer with regular tests including PSA, blood test and digital rectal examination every 6 months, a magnetic resonance imaging and prostate biopsy at the first year, and based on clinical decision thereafter. If there was a change on the results, the patient is considered for treatment.

Active Surveillance

It consists on the removal of the prostate gland and seminal vesicles with neurovascular preservation whenever anatomically and oncologically possible, with the Da Vinci procedure. Access is made through 5 or 6 small incisions, less than 1 cm. An extended pelvic lymph node dissection is performed when the risk estimation of node involvement is above the 5%. After surgery, the patient will be hospitalized for about 3 days and will probably resume his work activity between 3 and 5 weeks.

Robot-Assisted Radical Prostatectomy

Patients in this group undergo volumetric modulated arc therapy under daily image-guided radiation therapy in the supine position. Radiation is delivered in 2-3 Gy daily fractions, 5 days per week, with a prescription dose of 60-70 Gy to the prostate.

Intensity-Modulated Radiotherapy

Patients in this group receive I125 permanent seeds (low dose rate). The images are obtained with a transrectal ultrasound probe and are transferred to a planning system for calculating the number and position of the seeds. The prescrption dose is 145 Gy to the reference isodose (100%).

Real-time brachytherapy

The purpose of this study is to evaluate the effectiveness of four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and long-term follow-up. The primary aim is assessing the impact of treatments' side effects on patient's quality of life. As secondary objectives, biochemical disease-free survival, overall survival, and prostate cancer-specific survival will also be assessed.

Primary Objective:

To compare the impact of active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy in patients with localized prostate cancer, in Patient-Reported Outcome Measures, considering side effects and physical and mental health at short-, mid- and long-term follow-up.

Secondary Objectives:

To assess biochemical disease-free survival by treatment and risk group, at mid- and long-term follow-up.

To assess overall survival by treatment and risk group, at mid- and long-term follow-up.

To assess prostate cancer-specific survival by treatment and risk group, at mid- and long-term follow-up.

To assess perceived general health and cancer-specific quality of life by treatment and risk group, at short-, mid- and long-term follow-up.

To assess benefits and risks of the new treatment modalities for localized prostate cancer, compared with the traditional ones (open radical prostatectomy, external-beam radiotherapy and intersticial pre-planned brachytherapy).

To assess utilities with direct and indirect methods.

Outline:

This is a prospective observational study of a cohort with clinically localized prostate cancer treated with either active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy.

Participants are consecutively recruited in 18 Spanish hospital departments (located in six autonomous communities). Patients eligible for inclusion were: age 50-75, tumor stage T1c or T2a, N0 and M0; Gleason ≤ 6 (or 3+4 if T1c); Prostate Specific Antigen (PSA) ≤ 10 ng/mL; and to be treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, or real-time brachytherapy. Patients were excluded when body mass index was \>33, they had undergone neoadjuvant hormonal treatment, previous pelvic treatments, and/or had presence of serious comorbidities. The decision regarding treatment is made jointly by patients and health professionals.

Demographic and clinical characteristics at baseline are recorded at clinical sites and include age, PSA, Gleason score, prostate volume, risk group and use of adjuvant hormonal treatment. According to the national health guidelines, participants will be visited every 6-12 months after treatment, and at least annualy thereafter.

Quality of Life questionnaires are administered centrally by telephone interview before treatment and during follow-up at 1, 3, 6, and 12 months after treatment the first year, and annually thereafter. Quality of Life evaluations are gathered using computer-assisted telephone administration and include: (1) the Expanded Prostate cancer Index Composite (EPIC), specifically designed to measure the impact of the different treatments; (2) 36-item Short-Form Health Survey version 2 (SF-36v2); (3) the EuroQol-5 Dimension (EQ-5D-5L); and (4) the Patient-Oriented Prostate Utility Scale (PORPUS).

The sample size calculated to detect small differences between groups (0.3 SD) on the EPIC or SF-36v2 scores was of 90 patients per treatment group, given a statistical power of at least 80% at a significance level of 5%, and loss to follow-up of 10%.

New Treatment Modalities for Localized Prostate Cancer

Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer

Data processing complies with ethical principles and relevant national and international legislation (Reglamento General de Protección de Datos 2016/679 and Organic Law 3/2018, of December 5). The final data will only be accessible to people working on the study. No data used in the analyses and subsequent dissemination of the study results will contain any identifiable reference referring to the names of patients. Once the study is finished, the results will be communicated to the competent authorities, in accordance with local legislation.

Data and associated documentation will be made available to users only under a data sharing agreement that provides for:

* A commitment to use the data only for research purposes and not to identify any individual participant;
* A commitment to protect data through the use of appropiate information technology;
* A commitment to destroy or return the data after analyses are complete.

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a prostate cancer-specific questionnaire that measures urinary, sexual, bowel, and hormonal domains, ranging from 0 to 100. Response options for each EPIC item are on a 4-, 5-, or 6-level Likert scale. Items are grouped in summary scores for sexual, bowel, and hormonal domains, and in 2 scores for the urinary domain (incontinence and irritative/obstructive symptoms), which are transformed linearly to a scale from 0 to 100, where higher scores indicate better outcomes.

Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical relapse is measured by PSA levels. For patients treated with radical prostatectomy, biochemical relapse criteria of the American Urological Association is applied, and for patients treated with external radiotherapy or brachytherapy, criteria of the American Society for Therapeutic Radiology and Oncology is followed.

Number of participants who are alive after a specified duration of time. Vital status and data of death from any cause recorded by linkage with the National Institute of Statistics.

Number of participants who are not dead due to prostate cancer after a specified duration of time. Death due to prostate cancer according to the cause of death registered in the the National Institute of Statistics.

The 36-Item Short-Form Health Survey version 2 (SF-36v2) contains 36 items covering eight dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. For each dimension, a score ranges from 0-100 (higher score indicate better health).Physical and mental component summaries are constructed, using recommended scoring algorithms. Summary scores are standardized to have a mean of 50 and standard deviation of 10 in the US general population.

The EuroQol-5 Dimensions (EQ-5D-5L) is a generic econometric instrument that contains five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with five levels of severity in each dimension. From the possible combinations of scales and severity levels (3125 health states), a utility index is obtained, which ranges from 1 (perfect health) to negative values, 0 being the value attributed to death.

The Patient-Oriented Prostate Utility Scale (POPRUS) is a 10-attribute health state classification system that includes 5 broad items of health-related quality of life (pain, energy, social support, communication with doctor, and emotional well-being) and 5 prostate cancer-specific items (urinary frequency and incontinence, sexual function and desire, and bowel function. A multiattribute utility function is constructed using the patient-weighted utilities elicited with standard gamble. This utility index (PORPUS-U) ranges from 1 (perfect health) to 0 (dead).

Hospital Universitari de Bellvitge

Institut d'Investigació Biomèdica de Bellvitge

Hospitales Universitarios Virgen del Rocío

Hospital Regional Universitario Carlos Haya

Hospital del Mar

Hospital Universitario Rey Juan Carlos

Hospital Provincial de Castellon

Hospital Arnau de Vilanova

Hospital Universitario La Paz

Hospital Universitario La Fe

Hospital de Meixoeiro

Hospital Universitario 12 de Octubre

Hospital Universitario Reina Sofia de Cordoba

Hospital General Universitario de Valencia

Fundacion IMIM

Medical Doctor, PhD

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Pemetrexed

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Medication records in EHR database used to define exposure group

Pembrolizumab + Pemetrexed-Platinum

Medication records in EHR database used to define comparator group

Pemetrexed-Platinum

David Merola, PharmD, PhD

Investigators are building an empirical evidence base supporting the utility of real-world data through the emulation of randomized controlled trials in the oncology setting. The purpose of this work is to demonstrate whether real-world evidence studies can provide reliable conclusions on treatment effectiveness to inform further applications of real-world data in pharmaceutical product label expansion, post-marketing safety, and other purposes that are complementary to RCTs.

This is a non-randomized observational study that is being conducted as a part of the Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative, a multi-stakeholder collaboration led by Aetion. The study is intended to emulate the trial listed below/above. Although many features of the trial cannot be directly replicated in real-world data sources, key elements of the study design, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial as closely as possible. Investigators assume that the trial provides the reference standard treatment effect estimate and that failure to replicate trial findings is indicative of the inadequacy of the real-world data source for replication for a range of possible reasons and does not provide information on the validity of the original trial finding.

Emulation of the KEYNOTE-189 Trial Using Electronic Health Records

Emulation of a Comparative Effectiveness Study of Pembrolizumab and Chemotherapy vs. Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer

Data analysis code and de-identified patient-level data files may be made available, provided that it is determined that this will not violate the investigators' data usage agreements and patient privacy requirements.

Relative hazard of mortality due to any cause

Aetion, Inc.

Principal Scientist

Skin and Connective Tissue Diseases

Skin Neoplasms

Skin Diseases

PAE physician activation, plus teledermoscopy (PAE +MD +TD)

Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)

Patient activation and education (PAE)

Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients

PAE plus physician activation (PAE + MD)

Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients, and participant receipt of a dermoscopic lens

Alan Geller, RN, MPH

The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. This randomized controlled trial uses a three-group design.

Our specific aims are to: (1) Determine the impact of a Patient Activation and Education intervention with and without physician activation and teledermatology on skin cancer early detection practices, (2) Determine the impact of the intervention on time to diagnosis, and (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.

There are currently more than 420,000 Americans who are long-term survivors of childhood and adolescent cancer. While these groups have greatly benefited from recent medical advances, primarily increasing overall survival rates, treatment advances have come at a cost. It is now clear that childhood radiation therapy has caused survivors to be at extremely high risk for non-melanoma skin cancer (NMSC) and increased risk of melanoma. Early detection is crucial to reduce the morbidity caused by NMSCs and the morbidity and mortality incurred due to melanoma. Both patient and provider action are needed to detect and treat early skin cancers and to find new solutions to ensure expedited follow-up care and treatment, especially among those who live where they have little access to dermatologists.

The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. All participants will receive text messages encouraging them to examine their skin and request physician examinations while concurrently driving them to a study website that provides education related to the associated skills, and reinforces and expands the text messages. To reduce skin cancers among this young and dispersed patient population, this study will address several key issues: (1) how to provide patients with the skills needed to conduct effective skin self-examinations; 2) how to prompt action from patient's physicians when worrisome moles and lesions are found; and 3) how to ensure rapid access to dermatologic exams, which in some parts of the US can take weeks or months to schedule.

Reducing Skin Cancer Risk in Childhood Cancer Survivors

Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 2 months prior to the 18-month follow-up assessment.

Completion of a physician skin exam will be assessed by participant report and chart review.

A shorter time interval between the first finding of a suspect lesion after randomization and a diagnostic visit will be assessed by participant report and chart review.

St. Jude Children's Research Hospital

Dana-Farber Cancer Institute

Memorial Sloan Kettering Cancer Center

Harvard School of Public Health (HSPH)

RN, MPH

Carcinoma, Hepatocellular

Liver Diseases

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Extracts

Individuals randomized to Group 1 will receive usual medical care and will not be directly contacted at any point of the trial. Study data and outcomes will be abstracted from the EMR.

Individuals randomized to Group 2 will receive mailed outreach invitation.

Individuals randomized to Group 3 will receive mailed outreach invitation and patient navigation.

Individuals randomized to Group 2 will receive:

1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion. Up to three attempts will be made. All communications will use standard English or Spanish scripts.
3. Centralized process to promote guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.

Mailed Outreach Invitation

Individuals randomized to Group 3 will receive:

1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion "and address patients' self-reported barriers to HCC screening (e.g., it does not apply to me). Up to three attempts will be made. All communications will use standard English or Spanish scripts.
3. Centralized navigation to promote screening completion (i.e., appointment reminder phone calls from patient navigator) and guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.

Mailed Outreach Invitation and Patient Navigation

Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC.

Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to:

* Group 1: Usual care, with visit-based HCC screening per discretion of individual providers
* Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource intensity)
* Group 3: Mailed HCC screening invitation outreach to eligible patients combined with centralized patient navigation to promote screening completion and follow-up (high resource intensity)

Through three specific aims, this effectiveness research randomized controlled trial will:

* Aim 1: Engage stakeholders in design and implementation of HCC screening outreach interventions.
* Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention strategies to increase completion of one-time and repeat HCC screening.
* Aim 3: Evaluate whether intervention effects are moderated by patient sex, race, ethnicity, English proficiency, and connectedness to primary care.

The screening intervention strategies combine EMR-enabled case identification, system-level screening outreach, and patient navigation to improve identification of previously unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up of abnormal screening tests. This study will engage stakeholders throughout the research process, evaluate the effectiveness and acceptability of HCC screening strategies, and determine which patient subgroups benefit the most.

RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System

RCT of Strategies to Improve Screening Rates Among a Cohort of Cirrhotic Patients at High Risk for Developing HCC in a Safety-net Health System

Defined as the proportion of patients completing HCC screening within 6 months of randomization.

Defined as the proportion of patients completing HCC screening every 6 months within 18 months of randomization.

Defined as the proportion of patients completing HCC screening every 7 months within 21 months of randomization.

Defined as proportion of patients with HCC and the proportion of patients with early HCC.

Defined as proportion of patients completing any HCC screening.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer	NCT01326286	Prostate Cancer		18 Years - 79 Years	Vanderbilt University Medical Center
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening	NCT03414125	Colorectal Canc...	FIT Screening S... Choice Screenin...	50 Years - 63 Years	University of Texas Southwestern Medical Center
Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies	NCT01710215	Colorectal Canc...	FIT Screening S... Colon Screening...	50 Years - 64 Years	University of Texas Southwestern Medical Center
New Treatment Modalities for Localized Prostate Cancer	NCT05523856	Prostate Cancer	Active Surveill... Robot-Assisted ... Intensity-Modul... Real-time brach...	50 Years - 75 Years	Fundacion IMIM
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening	NCT03414125	Colorectal Canc...	FIT Screening S... Choice Screenin...	50 Years - 63 Years	University of Texas Southwestern Medical Center
Emulation of the KEYNOTE-189 Trial Using Electronic Health Records	NCT05908799	Non-small Cell ... Metastatic Lung...	Pembrolizumab +... Pemetrexed-Plat...	-	Aetion, Inc.
Reducing Skin Cancer Risk in Childhood Cancer Survivors	NCT02046811	Skin Neoplasms	Patient activat... PAE plus physic... PAE physician a...	30 Years - 65 Years	Harvard School of Public Health (HSPH)
Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies	NCT01710215	Colorectal Canc...	FIT Screening S... Colon Screening...	50 Years - 64 Years	University of Texas Southwestern Medical Center
RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System	NCT02312817	Carcinoma, Hepa... Liver Neoplasms	Mailed Outreach... Mailed Outreach...	21 Years -	University of Texas Southwestern Medical Center
Reducing Skin Cancer Risk in Childhood Cancer Survivors	NCT02046811	Skin Neoplasms	Patient activat... PAE plus physic... PAE physician a...	30 Years - 65 Years	Harvard School of Public Health (HSPH)
RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System	NCT02312817	Carcinoma, Hepa... Liver Neoplasms	Mailed Outreach... Mailed Outreach...	21 Years -	University of Texas Southwestern Medical Center

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