The intervention group will receive text messages for 21 days that are tailored to their oral agent regimen.

The control group will receive usual care, which consists of standard care and materials provided by the oncology office or pharmacy. In general, this includes instructions and information on the oral agent regimen (i.e., amount and timing), common side effects, how to manage symptoms, general ways to remember to take your pill (e.g., calendar or pill box), medication safety (i.e., storage), and how to contact a clinician for problems that arise.

Patients will be instructed to respond to the text message by sending a text stating if the oral agent was "taken". If there is no response after 15 minutes, a second text message will be sent out, again requesting a response. Satisfaction surveys will occur in the intervention group at week 5 when the text messages end; and will take five minutes.

Intervention group - texts

Sandra L Spoelstra, PhD, RN

The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale health-related research project on text messages to improve adherence to oral chemotherapy agents. Michigan State University College of Nursing has not been a major recipient of National Institute of Health grant funding. As a result, the overall objective of this proposal is to strengthen the research environment in the College of Nursing so that it can develop into a significant health-related scientific research enterprise. This project would involve undergraduate and graduate students, and thus, generate student interest in research as a career. The importance of the research planned for this proposal is as follows. More than 50 oral chemotherapy agents in pill form are currently on the market, with projections that in 3 years, 25% of cancer treatments will be delivered in pill form. For oral agents to achieve a therapeutically effective level for cancer treatment, patients must strictly adhere to the regimen. Adherence to oral cancer agents is often less than 80%, which may be inadequate for treating the cancer. To date, empirical research in the area of improving adherence to oral agents is underdeveloped. The goal of this research is to improve adherence to oral chemotherapy agents through a technology based strategy, tailored SMS text messages. This prospective randomized controlled trial will examine the feasibility, acceptability, and satisfaction with a 3-week tailored text message intervention for oral agent adherence. Descriptive statistics, generalized linear modeling, and generalized estimating equations will be used for analysis. In this proposal, preliminary data will be collected to examine efficacy of the text message intervention to promote adherence to oral agents. Data will then be used to further inform the development of an intervention to improve adherence to oral agents for an R01 application to conduct a larger randomized trial to test this innovative intervention. This study can have a transformative impact on oral agent adherence by developing a technology-based strategy to promote adherence among the increasing number of cancer patients who receive their cancer treatment in pill form. This type of novel intervention also has the potential to transform and impact many other ill populations that require adherence to a medication regimen.

The therapeutic outcome of cancer treatment for patients taking oral chemotherapy agents depends heavily on adherence to the oral agent regimen. Yet recent research indicated that patients miss one-third of oral chemotherapy agent doses. With more than 50 oral anti-cancer agents on the market, it is projected that within 3 years, 25% of cancer treatment will be delivered in pill form. In this new treatment paradigm, care is moved from the clinics to home settings. This means that patients are seen less frequently by oncologists and greater responsibility is placed on the patients. Complicating this further, 75% of those with cancer also have comorbid conditions that require them to perform other self-care management (SCM) responsibilities. In addition, many have low self-efficacy, which may interfere with their ability to adhere to the oral agent. The therapeutic outcome for patients taking oral agents depends heavily on engaging patients to adhere to the regimen. Thus, a critical need exists to test novel interventions that promote adherence in patients taking oral chemotherapy agents.

The long-term goal of this research is to develop novel interventions to improve bio-behavioral outcomes of patients with cancer who have treatment in pill form. The objective of this study is to determine the feasibility, acceptability, satisfaction and efficacy of a short message service (SMS) text message intervention to promote adherence among cancer patients prescribed oral agents. The strategy to achieve this objective is to examine how technology can be used to improve adherence and to explore translation of these technologies to the clinical setting by deploying the following research plan.

This 10-week, 2-group, prospective randomized controlled trial will enroll 75 patients (50 in the intervention group and 25 in the control group), from 2 cancer centers, to test the feasibility and efficacy of a tailored intervention using text messages delivered to patient's cell phones to promote oral agent adherence. As these patients are newly prescribed an oral agent, they will be randomly assigned to either the intervention or the control group. At baseline (week 1), we will assess age, sex, race, cancer type and stage, self-efficacy, comorbid conditions and their SCM, and symptoms. For 21 days (week 2-4) the intervention group will receive a tailored text message for oral agent adherence plus usual care and the control group will receive only usual care. Each week (week 2-9) and at exit (week 10) an assessment of oral agent adherence and symptoms will occur. Satisfaction with the intervention will also be evaluated during the exit interview.

Specific Aims

Aim #1. To determine feasibility, defined as patient acceptance, retention in the study, and satisfaction, of a tailored text message intervention among patients who are on oral agents. Hypotheses to be tested are:

Hypothesis 1a: 80% of participants recruited will enroll in the study.

Hypothesis 1b: 80% of patients in the intervention group will complete 21 days of tailored text messages.

Hypothesis 1c: 90% of the intervention group will be satisfied with the tailored text messages.

Aim #2. To determine preliminary efficacy of the tailored text message intervention on adherence to oral agents. Hypotheses to be tested are:

Hypothesis 2a: The intervention group will have significantly higher rates of oral agent adherence than the control group.

Hypothesis 2b: There will be a large effect size of the intervention for group differences in adherence rates.

Exploratory aim: To explore the effect of oral agent complexity, low self-efficacy, symptom severity, comorbid conditions, and SCM of comorbid conditions on adherence to oral agents. We expect that adherence will be greater for patients with higher self-efficacy, simple oral agents, for those with fewer comorbid conditions, for those with fewer SCM responsibilities for their comorbid conditions, and for those with lower symptom severity.

This study can have a transformative impact on oral agent adherence by developing an easy-to-use, technology-based intervention to promote adherence among the increasing number of cancer patients whom receive treatment in this manner.

The significance of this study is that it targets a difficult clinical problem among patients who are very sick with a life threatening disease and must adhere to complex treatment protocols. This innovative intervention involves a readily available technology that can be used to interact with patients on a regular, consistent basis that would otherwise not be possible, feasible, or cost effective if done in a one-by-one interaction with a health care provider. The number of cancer patients who receive chemotherapy in pill form is increasing and this intervention will enable them to adhere and complete their cancer treatment. Thus, the intervention has high generalizability and the potential to transform care.

Text Messaging to Improve Adherence to Oral Chemotherapy Agents

The Cancer Self-Efficacy Scale (CASE), a self-report measure, will be administered (internal consistency reliability 0.95); Symptom Experience Inventory; and comorbidity presence on adherence as in stated measures

Feasibility of adherence to tailored text messages will be measured by the number of text messages delivered and any discontinuation of text messages during the course of the study while treatment with the oral agent is ongoing.

Acceptability of tailored text messaging will be measured by the number of patients who accept enrollment in the study compared to the number of patients who were offered to participate and by the percent of patients who complete the study. Acceptability will be assessed qualitatively by examining the reasons for attrition in the intervention group.

Satisfaction with tailored text messages for adherence will be measured using a tool previously developed by this research team and administered in several previous studies that had Likert-scaled items. These Likert-scaled items will be modified for this study, adding items describing dimensions of satisfaction with the text messages. Satisfaction will be deemed high if the scores exceed 80%.

Patients will be asked to recall and report the number pills taken (pill count) in the past 7 days at exit.

The proportion of oral agent pills taken compared to what was prescribed will be calculated to determine the rate of adherence. Adherence will be examined at 3 levels: under-adherent (taking less than 85% of the prescribed dose); over-adherent (taking more than 100% of the prescribed dose in AM, PM, or both, or taking during rest periods); and adherent (taking between 85% and 100% of the medication); and cumulative.

The relative dose intensity (RDI) will be calculated by examining the dose taken divided by standard dose intensity (prescribed number of pills) x 100.

Yale University

Sparrow Health System

Diplomat Pharmacy

Huron Medical Center

Allegiance Health

McLaren Cancer Institute

Michigan State University

Assistant Professor

Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Behavior, Addictive

Skin Neoplasms

Compulsive Behavior

Impulsive Behavior

Participants in the text messaging intervention arm receive mobile text messages communicating the risks of indoor tanning and motivating cessation on their mobile phones

Participants in the control arm receive no intervention

Participants in the intervention arm will receive text messages to their mobile phones designed to communicate the risks of indoor tanning and motivate cessation. The intervention exposure lasts for 4 weeks with messages sent 2 days each week. It is an interactive intervention that engages participants by asking them to respond to prompts, and sending indoor tanning message content in return on message days.

Mobile text messaging intervention

Darren Mays, PhD, MPH

The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, addictiveness) of indoor tanning delivered via mobile text messaging among young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction.

This is a two arm randomized controlled trial to test the effects of messages communicating the risks of indoor tanning delivered via mobile text messaging as a strategy for promoting cessation among young adult women who meet screening criteria for indoor tanning addiction. Eligible participants are young adult women ages 18 to 30 years who meet screening criteria for indoor tanning addiction and have access to the internet and a personal mobile phone to complete study procedures. Participants will complete baseline measures and then be randomized to the study arms. The text messaging intervention exposure in the intervention arm will last for four weeks. The control arm will be given basic indoor tanning education information and will not receive any intervention. Follow up assessments capturing study outcomes will be administered at 1 month (i.e., immediately post-intervention) and three months post-intervention.

This is a randomized trial with two groups: 1) Indoor tanning education only; 2) Mobile text messaging intervention

A Mobile Text Messaging Intervention for Indoor Tanning Addiction

We will consider requests to share de-identified IPD individually and according to the investigator's study protocol and institutional data sharing policy.

Perceived risk of harm are measured by asking participants how likely harms are to occur (1 = no chance, 7 = certain to happen). Worry about harms are measured by asking participants how worried they are about harms of indoor tanning (1 = not at all, 7 = very much). Greater risk appraisals are considered a better outcome. The items are administered at 1 month follow up and at 3 month follow up.

Beliefs about the health benefits of quitting indoor tanning, efficacy beliefs, are measured using 6 questions asking about health benefits occurring from quitting indoor tanning (1 = No Chance, 7 = Certain to Happen). Greater efficacy beliefs are considered a better outcome. These items are administered at 1 month follow up and at 3 month follow up.

Motivation to quit is measured by participant report by a single question with a 1 to 7 response scale. Higher scores indicate greater motivation to quit and are considered better outcomes. This question is administered at 1 month follow up and at 3 month follow up.

Indoor tanning cessation is measured by participant report by a single question asking if participants have stopped indoor tanning completely. Responses indicating cessation are considered better outcomes. This item is administered at 1-month follow-up and at 3 month follow up.

Attempts to quit indoor tanning are measured by participant report by a single question asking if participants have attempted to quit indoor tanning since the last assessment. Responses indicating any attempt(s) to quit are considered a better outcome. This item is administered at 1 month follow up and at 3 month follow up.

Georgetown University

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Emergencies

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Disease Attributes

Subjects who are determined to be non-adherent to screening guidelines and are assigned to usual treatment via randomization in REDCap.

Subjects who are determined to be non-adherent to screening guidelines and are assigned to intervention treatment (text messaging) via randomization in REDCap.

A series of theory-informed text messages encouraging them to contact their primary care provider and the UR LCS Program's Patient Navigator to coordinate screening, along with contact information to do so.

Text Messaging

David Adler, MD

This is a randomized controlled pilot trial of a text-based behavioral intervention aimed at increasing uptake of lung cancer screening among emergency department patients. We will conduct a 2-year randomized controlled clinical trial with a prospectively collected convenience sample of 366 adults who are eligible for LCS but non-adherent with LCS screening guidelines. Adults aged 50-80 will be recruited from a high-volume urban ED and a low-volume rural ED, assigned to study conditions, and followed-up at 150 days to assess interval engagement with the University of Rochester Medical Center's LCS screening program (primary outcome). Electronic Health Record (EHR) review will be conducted to assess screening results and subsequent clinical endpoints.

Lung cancer is the number one cancer cause of death in the US1 accounting for a quarter of all cancer deaths. Five-year survival for lung cancer is just 19%. However, early detection of lung cancer increases 5-year survival three-fold and lung cancer screening (LCS) among high-risk patients using low-dose CT scan is cost-effective and has been proven to reduce lung cancer mortality by approximately 20%. Despite this potential, uptake of LCS has been poor with only 14.4% of eligible patients found to have been screened in a recent 10 state study. Indeed, the US Department of Health \& Human Services and the USPSTF have both explicitly prioritized increasing the uptake of LCS among their goals. In 2021, the USPSTF revised the eligibility criteria for LCS, expanding the age range to 50-80 and lowering the pack-year threshold to 20.

The Emergency Department (ED) is an ideal setting to target an intervention aimed at increasing LCS uptake because the patient populations most in need are available for intervention. Our team has been at the forefront of ED-based cancer prevention efforts, serving as investigators on preventive work on cervical cancer and smoking cessation. EDs care for a disproportionate number of patients with the socio-economic factors that are associated with vulnerability to non-adherence with LCS including non-White race, lower income, and lack of health insurance. Moreover, smoking accounts for 90% of all lung cancer and ED patients have a higher smoking prevalence than the general population. In addition, ED visits generally involve periods of waiting during which preventive health needs can be assessed and intervened upon. LCS is a complex process - it is more than just an imaging study. However, the first critical step is to engage high-risk patients with this process. USPSTF has emphasized the importance of "pathways besides referral from primary care" to the success of this effort.

The vast majority of Americans - 95% - own a cell phone and an estimated 98% of all cell phones have SMS capabilities. Importantly, while there still exists a "digital divide" with regards to home computing among Americans of different backgrounds, phone ownership is nearly identical among white, black, and Hispanic Americans. SMS health interventions have been studied for over a decade and have been proven effective for a wide range of applications including smoking cessation, diabetes self care, and breast cancer screening. SMS interventions are low-cost, not staff-intensive, simple, familiar, scalable, tailorable to individuals, instantaneous in delivery, asynchronous in receipt, reproducible, and accessible regardless of geographical or socioeconomic factors. Our project adapts and targets this effective technology to improve LCS uptake among ED patients.

An empirically supported theoretical framework is central to developing an effective behavioral intervention, particularly in a setting like the ED where a long-term therapeutic relationship cannot be leveraged. The proposed trial makes use of two complementary theories: the Theory of Planned Behavior (TPB) and Self-Determination Theory (SDT). The TPB posits that the strongest predictor of a behavior is the intention to engage in the behavior. These intentions are predicted by an individual's attitudes toward the behavior, subjective normative beliefs about the behavior, and perceived control over whether they can perform the behavior. SDT states that individuals are motivated to engage in behaviors that satisfy the needs for (a) autonomy, (b) competence, and (c) relatedness. Individuals are autonomously motivated when these needs are met, which leads to engagement in a behavior.

The proposed study will utilize a randomized, prospectively collected, convenience sample and a longitudinal design with a sample size of 366 recruited from urban and rural UR Medicine EDs. Research enrollers will determine adherence of patients to USPSTF LCS recommendations using an adaptive REDCap survey. Non-adherent patients will be randomized to intervention or control conditions, with patients in the intervention condition receiving a series of theory-informed text messages encouraging them to contact their primary care provider and the UR LCS Program's Patient Navigator to coordinate screening, along with contact information to do so. Follow-up to determine LCS program uptake (primary outcome) will occur at 150 days, at which time feedback will also be solicited.

The proposed study will utilize a randomized, prospectively collected, convenience sample and a longitudinal design.

Emergency Department Lung Cancer URMFG Pilot

Increasing Lung Cancer Screening Uptake Among Emergency Department Patients

Comparison of non-adherent intervention and control subjects for who are compliant with screening guidelines by the 150 day assessment

Preliminarily assess quality indicators driven by engagement of study participants with the LCS program.

Qualitative analysis of subject feedback on barriers to obtaining screening and perceptions of the intervention in order to inform refinement and implementation of the intervention.

University of Rochester

Professor

Rare Diseases

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Germ Cells Tumors

SMS before appointment detailing the date of consultation and exams to be performed before

short message service

Elise ROBERT

Elise Robert

This study will evaluate the impact of Short Message Service (SMS) on compliance with surveillance of patients with germ-cell tumors. Patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder SMS before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without SMS.

Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors

Phase II, Open-label, Randomized, Non-comparative Study Evaluating the Impact of Short Message Service (SMS) on Compliance With Surveillance of Patients With Germ-cell Tumors. (TEXTIS Study)

Optimal compliance is defined according to the following 2 parameters:

* The patient comes to all the appointments, on the expected day, AND
* With all the biological and imaging exams previously scheduled by the physician.

Intermediate compliance is defined according to the following 2 parameters:

* The patient comes to all the appointments, but in one of the consultations, he delays his scheduled appointment of more than 3 weeks but less than 6 weeks OR
* Missing a biological or imaging exam.

Non compliance is defined according to the following 3 parameters:

The patient misses a consultation, without warning, OR

* He delays of more than 6 weeks his appointment of consultation, OR
* At least 2 biological or imaging exams requested by the oncologist are missing from all consultations.

It is evaluated with the following question: do you find that having reminder sms for your appointments and exams is useful? evaluated on a scale of 0 to 10 (0: useless, 10: useful)

Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).

Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.

Centre Hospitalier Universitaire de Besancon

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 10-week text messaging program focused on recovery after radical prostatectomy surgery.

Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.

Arm C receives the following: Arm A material plus access to an online portal with additional educational materials to help improve diet habits and various tools, such as the ability to track diet; additional educational print materials on diet; additional text messages over 2 years that supports healthy diet habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.

Arm D receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise and diet habits and various tools, such as the ability to track exercise and diet; additional educational print materials on exercise and diet; additional text messages over 2 years that supports healthy exercise and diet habits; a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.

Behavioral program provides access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D)

Exercise and Diet

Stacey A Kenfield, DSc

The Prostate 8-II study is a randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.

This is a PI initiated, randomized controlled trial of four exercise and diet interventions among men opting for radical prostatectomy for prostate cancer.

The Prostate 8-II study enrolls men up to 8 weeks prior to surgery and participants remain on study for 24 cycles after surgery (1 cycle=28 days). After obtaining written informed consent, enrolled subjects will be scheduled for the baseline assessments. All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment. The other 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Men in all arms will be asked to complete questionnaires at baseline, pre-surgery, and at cycles 6,12, \& 24 post-surgery, and complete blood and urine collection, diet recall, and accelerometer measurement at select time points. Specimens from biopsy and radical prostatectomy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores. Participants will be followed for 30 days after completion of the 2-year 24-cycle intervention period or removal from the study, or until death, whichever occurs first for any treatment-related adverse events. Following the completion of the intervention, participant's treatment and disease status will be collected on a yearly basis, for 3 more years.

Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)

A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)

Detectable PSA will be defined based on current practice at the time of analysis. Point estimate and 95% confidence interval of the proportion of detectable PSA at 6 months and 2 years post-surgery for each group will be reported. In addition, Pearson's Chi-square test will be used to test if there are differences in the proportion of detectable PSA at least 6 weeks post-surgery among the groups. If there is a significant difference observed, a 2-sample proportion test to compare Groups B, C, and D, separately, with Group A and one another for each post-intervention time point will be performed. Point estimates and 95% confidence intervals of the recurrence proportion will be obtained for each group

Risk of cancer recurrence (based on current practice) measured using standard criteria using a log- rank test to evaluate the time to recurrence among groups, and multivariate Cox proportional hazards regression to obtain a hazard ratio for the time to recurrence

Effect of intervention on changes in mRNA expression patterns using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in formalin-fixed paraffin-embedded (FFPE) prostate biopsy and prostatectomy tissue to determine which genes are differentially expressed from biopsy to RP within each group. If the expression is significantly different in at least one of the groups, the change of RNA expression level will be compared among all groups by ANOVA. If there is a significant difference observed, we will perform pairwise comparisons among the groups. Multiple testing adjustment will be done by controlling false discovery rate

Assessment of genomic classifiers, using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in FFPE (formalin-fixed paraffin embedded) prostate biopsy and radical prostatectomy tissue. Each score ranges from 0 to 100 and can be interpreted as a probability of progression. The 2-sample proportion test will be used to compare the proportion of reduction in the genomic score between Groups B, C, and D, separately with Group A first. Significant mean changes in the Decipher score will be tested using Analysis of Variance (ANOVA). If there is a significant difference observed, pairwise comparisons among the groups will be performed. A regression model will be built using an indicator for group and stratification factors such as age at diagnosis and surgical parameters (e.g., CAPRA-S) which have been determined to be potential covariates.

The EPIC-26 will be used to determine the impact of quality of life issues on the sexual function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).

The EPIC-26 will be used to determine the impact of quality of life issues on the urinary function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).

General anxiety items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of anxiety. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - 18 items assessing prostate cancer anxiety, PSA anxiety, and fear of recurrence; range 0-54; smaller number is better.

General depression items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of depression. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS \& MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health.

Patients will wear an Actigraph GT3X+ accelerometer on their wrist for 7 consecutive days to measure physical activity

The Godin-Shephard Leisure-Time Physical Activity Questionnaire measures the frequency and duration of various types of physical activity (strenuous, moderate, light) and each is weighted by multiplying the frequency by a corresponding multiplier (x9, x5, x3 respectively) during a typical 7-Day period. The weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). A score of 24 units or more indicates a status of "Active", 14 - 23 units "Moderately Active" and \< 14 units "Insufficiently Active/Sedentary".

The FFQ is a self-administered questionnaire to assess intake of various nutrients. Nutrient intakes are computed by assigning a daily frequency weight

Two online 24-hour diet recalls as recommended by the National Cancer Institute's Diet Assessment Primer

Various metrics for study feasibility (e.g., text message, portal, and coaching use) will be measured over time. Study acceptability will be evaluated by survey and in a subset, by phone interview. Descriptive data of these metrics across arms will be reported

Confidence scores in adopting dietary and physical activity behaviors at for each group using descriptive statistics, such as means, medians, and interquartile range will be reported using descriptive statistics.

In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality

Social support will be measured using published measures from University of California, San Diego (http://sallis.ucsd.edu/measure_socialsupport.html

National Cancer Institute (NCI)

University of California, San Francisco

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. At the end of the study they will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.

Provider Referral

Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. They will also receive a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening. They will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.

The purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. Cervical cancer screening is an important part of cervical cancer prevention. The study team will determine if the patient is currently up-to-date with cervical cancer screening recommendations. If the patient is not up-to-date, then they will be randomly assigned to one of two interventions. One intervention consists only of referral to a women's health care provider to obtain cervical cancer screening. The other intervention consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening.

Promoting Cervical Cancer Screening for Emergency Department Patients

Piloting Interventions to Improve Adherence to Cervical Cancer Screening Recommendations Among Emergency Department Patients

National Institutes of Health (NIH)

Associate Professor of Emergency Medicine

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Control subjects will receive no text intervention and a 150 day follow-up phone call.

Intervention subjects will receive the text messaging intervention and a 150 day follow-up phone call.

Text messages based on behavioral theory to encourage scheduling colorectal cancer screening.

In this project, we intend to conduct a randomized pilot trial of a structured behavioral intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening recommendations. We will also collect qualitative feedback on perceptions of the intervention to inform its refinement.

The investigators propose a pilot randomized controlled trial with a prospectively collected convenience sample of 130 ED patients non-adherent with CRC screening guidelines over a 3-month period. ED Research Associates (EDRAs) will use the EPIC eRecord system to screen adult patients registered in the ED at URMC and Noyes Memorial Hospital (when an EDRA is present in that ED) for eligibility. Inclusion criteria will include: 45-75 years and English or Spanish speaking (costs for interpreting study surveys and patient interactions will be paid for from PI discretionary research funds). Exclusion criteria will include personal and/or family history of colorectal cancer, personal history of inflammatory bowel disease, and a history of abdominal or pelvic radiation to treat a prior cancer. These exclusions were chosen due to their impact on standard colorectal screening recommendations. After consent, subjects will complete a \~10-minute questionnaire administered by the EDRA to determine adherence to current USPSTF guidelines for colorectal cancer screening using validated items in the CDC's National Health Interview Survey16. The enrollment process will categorize study participants into three groups: adherent, uncertain, or non-adherent. Subjects found to be adherent will be notified and their participation will conclude. Subjects found to be in the uncertain or non-adherent groups will be randomized into the treatment or control condition. Following intervention, subjects who were non-adherent will be referred to their usual care provider to discuss options for becoming adherent. Subjects for whom adherence is uncertain will be referred to their usual care provider to confirm their adherence status. Subjects who find through their PCP that they are adherent will be treated as screen failures. Sensitivity analyses will be performed to evaluate estimates of intervention efficacy with and without inclusion of subjects initially determined uncertain and later categorized as non-adherent. Following the initial enrollment, randomization, and recommendation to contact their PCPs, subjects in the intervention condition will receive a series of 6 text messages, sent at approximately 15 day intervals, presenting theory-based messages aimed at encouraging colorectal cancer screening uptake. Subjects without a primary care provider will be given information on how to establish a PCP in Rochester and on cancer screening services subsidized through the Cancer Services Program (CSP) of the Finger Lakes Region (our current R01 includes referrals to the CSP). All subjects in the non-adherent and uncertain groups will receive a follow-up call at 150 days for a \~5-minute survey to determine if they underwent or scheduled screening, if they learned that they did not require screening, and what barriers they perceived in getting screened. Qualitative feedback regarding perceptions of the intervention will also be collected in order to refine the intervention for future study. Medical chart review will also be conducted to confirm patient self-reports, making use of UR records and records from the Rochester Regional Health Information Organization (RHIO; our current R01 has incorporated the RHIO).Completion of a "second-level" consent form for use of the RHIO for chart review will be required for enrollment. In our cervical cancer pilot study, we successfully contacted 68% of participants for follow-up, 11 of whom declined to complete the follow-up interview. Based on lessons learned in our preliminary work, we have developed several strategies (currently employed in our R01 study), in addition to the incentive payment for study completion, which we will employ to maximize retention in this study:

1. Telephone numbers will be confirmed in the ED during enrollment by the EDRA performing the enrollment by calling the patient's phone to be certain the number is correct.
2. Up to five calls will be made to each study participant during the follow-up window.
3. Each participant will be provided with study team contact information and asked to notify us in the event that their phone number changes.
4. In addition to their primary cell phone number, alternative contact information will be sought from each participant to enable attempts at re-engagement, including: a.Secondary telephone number of participant b.Email address(es) and mailing address.
5. The EHR will be accessed to check for changes in contact information

Randomized controlled trial with a prospectively collected convenience sample

Text-based Colorectal Cancer Prevention Pilot

Text-based Intervention to Improve Adherence to Colorectal Cancer Screening Recommendations Among Emergency Department Patients

Rates of completed or scheduled screening

Collect qualitative feedback on perceptions of the intervention to inform its refinement.

Associate Professor

Usual Care

Access to Become an Ex website plus text messaging

WEB+TXT

Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist

WEB+TXT+TTS

James T Hays, MD

David E Midthun, MD

This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.

Using a 3-arm randomized trial design with repeated measures at 1, 3, 6, and 12 months, the study will randomize N=1650 smokers who present for LDCT lung cancer screening to an passive referral usual care control condition, proactive referral to a digital cessation intervention that combines web and text messaging, or proactive referral to a digital cessation intervention combined with Tobacco Treatment Specialist counseling. The Study will examine overall effectiveness of the interventions in promoting abstinence, the impact of proactive referral to treatment, and the total cost and cost effectiveness of the interventions. The Study will also examine the representativeness of the enrolled sample and explore barriers and facilitators to intervention adoption with LDCT clinic leaders. The trial is structured as a practical clinical trial to answer key questions of direct relevance to LDCT decision-makers.

Low Dose Computed Tomography for Lung Cancer Screening

Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach

biochemically confirmed 12 month smoking abstinence of WEB+TXT;

biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ;

biochemically confirmed 12 month smoking abstinence of UC;

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Text Messaging to Improve Adherence to Oral Chemotherapy Agents	NCT01889511	Cancer	Intervention gr...	21 Years -	Michigan State University
Text Messaging to Improve Adherence to Oral Chemotherapy Agents	NCT01889511	Cancer	Intervention gr...	21 Years -	Michigan State University
A Mobile Text Messaging Intervention for Indoor Tanning Addiction	NCT04055272	Indoor Tanning	Mobile text mes...	18 Years - 30 Years	Georgetown University
Emergency Department Lung Cancer URMFG Pilot	NCT04979169	Lung Cancer	Text Messaging	50 Years - 80 Years	University of Rochester
Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors	NCT03868176	Follow-up Compliance, Pat... Text Messaging Germ Cell Tumor	short message s...	18 Years -	Centre Hospitalier Universitaire de Besancon
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)	NCT03999151	Prostate Cancer	Exercise and Di...	18 Years -	University of California, San Francisco
Promoting Cervical Cancer Screening for Emergency Department Patients	NCT03483610	Cervical Cancer	Provider Referr... Text Messaging	21 Years - 65 Years	University of Rochester
Promoting Cervical Cancer Screening for Emergency Department Patients	NCT03483610	Cervical Cancer	Provider Referr... Text Messaging	21 Years - 65 Years	University of Rochester
Text-based Colorectal Cancer Prevention Pilot	NCT05004376	Colorectal Canc...	Text Messaging	45 Years - 75 Years	University of Rochester
Low Dose Computed Tomography for Lung Cancer Screening	NCT03084835	Smoking	Usual Care WEB+TXT WEB+TXT+TTS	18 Years -	Mayo Clinic
Low Dose Computed Tomography for Lung Cancer Screening	NCT03084835	Smoking	Usual Care WEB+TXT WEB+TXT+TTS	18 Years -	Mayo Clinic
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)	NCT03999151	Prostate Cancer	Exercise and Di...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for text messaging