Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

In the financial incentive group (Group B), participants will receive reimbursement for transportation, accommodation, and food costs, along with RMB 200 (about 30 US dollar) to compensate for potential income loss due to endoscopy, provided they undergo the procedure.

For the motivational intervention group (Group C), researchers will provide detailed information about the social norms surrounding endoscopy screening, including the prevalence of screening participation, the potential risks of gastric cancer, and the health benefits of screening.

Participants in the mixed intervention group (Group D) will receive both financial incentives and motivational intervention.

In the financial incentive group, participants will receive reimbursement for transportation, accommodation, and food costs, along with RMB 200 (about 30 US dollar) to compensate for potential income loss due to endoscopy, provided they undergo the endoscopy.

Financial Incentives

For the motivational intervention group, researchers will provide detailed information about the social norms surrounding endoscopy screening, including the prevalence of screening participation, the potential risks of gastric cancer, and the health benefits of screening.

Motivational Intervention

Participants in the mixed intervention group will receive both financial incentives and motivational intervention.

Mixed Intervention

Li Yang, PhD

Gastric cancer, also known as stomach cancer, is a serious disease that affects the stomach. It's one of the most common types of cancer, and sadly, many people die from it each year. But there's hope! We can catch gastric cancer early with a special test called endoscopy. This test helps doctors find cancer or pre-cancerous changes in the stomach early, when it's easier to treat. However, not enough people get this test, especially in places where healthcare isn't easily available. That's why we're doing this study.

We want to find out if we can encourage more people to get the endoscopy test for gastric cancer. We're going to try two different ways to encourage people to get the test. First, we'll give some people money or other incentives to help cover the costs of getting the test. Second, we'll give others information and support to help them understand why the test is important and how it can help them.

We'll be doing this study in two provinces in China, where gastric cancer is a big problem. We'll ask thousands of people to join the study, and we'll randomly assign them to one of the two groups. Then, we'll see if more people in one group get the endoscopy test compared to the other group.

Our hope is that by finding out what works best, we can help more people catch gastric cancer early and get the treatment they need. This could save many lives and make a big difference in fighting this disease.

Gastric cancer (GC) remains a significant global health challenge, with high mortality rates, particularly in low- and middle-income country, like China. Early detection through screening is crucial for improving prognosis and reducing mortality. However, uptake of GC screening remains suboptimal, highlighting the need for effective interventions to promote screening participation.

This study employs an experimental design to evaluate the effectiveness of two interventions, financial incentives and motivational interventions, in promoting GC screening uptake at the individual level. A large sample size will be recruited from high GC-burden provinces in China, and participants will be randomly assigned to intervention and control groups. Statistical analyses, including Propensity Score Matching and Interrupted Time Series Analysis, will be utilized to assess the impact of interventions on screening uptake and adherence.

Findings from this study will be disseminated through peer-reviewed publications, conference presentations, and engagement with stakeholders to inform evidence-based strategies for improving GC screening and reducing GC-related morbidity and mortality.

Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China

Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China: An Individual Level Randomized Controlled Trial Study Protocol

Our primary outcome is the rate of individuals undergoing endoscopy screening within three months.

Our primary outcome is the rate of individuals undergoing endoscopy screening within six months.

the proportion of participants adhering to follow-up endoscopy appointments at one- or two-years post-intervention

Peking University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Urinary Bladder Neoplasms

Postoperative Complications

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days.

Subjects will use Fitbit Zip to track step counts

Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts

Financial Incentive and possibility for financial lottery entry in addition to education on the benefits of post-surgery ambulation

Financial Incentive to Increase Ambulation

Gregory Tasian, MD,MSc,MSCE

Thomas Guzzo, MD, MPH

Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the risk of readmission, and adds substantially to health care costs. Protocols that emphasize early and frequent ambulation after surgery decreases post-operative morbidity, but poor patient adherence diminishes the effectiveness of these protocols, which are currently implemented only during the hospital stay. Financial incentives overcome present bias and offer a novel and practical approach to increasing ambulation during the post-operative period in the hospital and also after discharge. This application proposes a pilot randomized, controlled trial to estimate the effect size of financial incentives on achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month following radical cystectomy. Secondary outcomes include step count, composite morbidity, and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the Hospital of the University of Pennsylvania will be randomized to either control (education of step goal with monitoring and daily feedback) or a gain financial incentive combined with a lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips will be used to measure step counts for all participants. This proposal will provide the preliminary data needed to design future, larger trials that will test the effect of financial incentives to increase ambulation on post operative complications, readmissions, and functional decline.

In this application, a randomized controlled trial will be used to test the hypothesis that small financial incentives can be used to increase post-operative ambulation. The randomized controlled trial design is necessary to demonstrate a causal relationship between the intervention (provision of financial incentives)and the outcome (increased ambulation). This design will also provide preliminary data (e.g. effect sizes, feasibility) needed to design larger trials that will determine whether increases in ambulation produced by financial incentives can be translated into decreases in clinically relevant outcomes such as post-operative complications, readmissions, and functional decline in patients undergoing major abdominal surgery.

All participants will receive education about the importance of early ambulation and knowledge of their daily step goals. A Fitbit Zip, a commercially available activity tracking device with the ability to record and wirelessly upload step counts, will be provided to each participant to measure the outcome of daily step counts for a lead in period of 1-2 weeks before surgery and 30 days after surgery with the option for patients to continue to submit data independently for up to 90 days after surgery. The lead-in period will provide data to determine a patient-specific daily step count baseline. Step count goals will change each week and be determined by a set-percentage of the patient-specific baseline. The percentages will be as follows: 10% of baseline for week 1, 25% of baseline for week 2, 40% of baseline for week 3, and 55% of baseline for week 4. Data will be collected using the Way To Health platform, a digital platform specifically designed to facilitate randomized controlled trials testing interventions increase health promoting behavior.

Participants will be randomized using simple balanced randomization into one of two arms: "control" or "financial incentives". Individuals will be informed if they fail to achieve adequate steps and would have otherwise been eligible for payments in order to leverage regret aversion. The financial incentive is framed as a "gain" rather than a "loss" because striving to achieve a positive reward may provide the necessary support to positively motivate patients who just had major, painful surgery. Small definite payments are combined with larger lottery-based payments to provide ongoing feedback coupled with the possibility of winning a higher magnitude reward. Automated notification about payments will be delivered through the participant's preferred mode of communication (e.g., phone call, email). Patients will track their earnings and step count over time through Way to Health.

Beginning shortly before the planned surgery and continuing for 30 days after date of surgery, all participants will use Fitbit Zips to measure daily step counts. Patients will have the option of submitting up to 90 days of post-operative data. Post-operative ambulation has been repeatedly demonstrated to be beneficial to recovery by a number of different metrics, and the Zip device has been shown to be an accurate measure of step counts. The Stanford Health Assessment Questionnaire (SHAQ) is a broadly used and validated questionnaire which, in its shortened form, assesses subjects ability to perform 20 different actions and the need for assistance with these actions. It also captures patients global assessments of pain and well-being. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measured post-operative functional decline. The International Physical Activity Questionnaire (IPAQ) Short Seven Day form quantifies patient reported levels of physical activity over the seven days prior to the interview. It is similarly broadly used and has been previously validated against accelerometer data. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measure post-operative decline in physical activity and to discover differences in baseline physical activity that are not captured by preoperative step-count data.The Multidimensional Scale of Perceived Social Support (MPPSS) is a validated tool for assessing patient's self-assessed degree of support from others. Prior research has suggested social support as an important factor in exercise behavior, which is consistent with our clinical observations. This will be administered pre-operatively and a 30 and 90 days post-operatively to help account for confounding by this important and otherwise unmeasured variable.

Steps to Eliminate Postoperative Problems

Number of days during the study period that each subject reaches their step goal

Average number of steps taken per day in the 30 day postoperative period. Note that the average number of steps taken per day is calculated separately for each patient as simply (total number of steps taken in the 30 day postoperative period)/30. For the purposes of comparing the two study groups, nonparametric tests and medians are used. Thus the "measure type" listed in the "Outcome Measure Data Table" is correctly listed as "median". For example, in the Financial Incentive arm, we report a median average number of steps per day as 979, implying that half of the patients walked fewer than 979 steps on an average day and half of the patients walked more than 979 steps on an average day in that group.

Binary variable reflecting whether or not patient suffered any of the following: any postoperative complication, any unplanned readmission, any presentation to the emergency department within 30 days after surgery.

30-day postoperative Stanford Health Assessment Questionnaire Disability Index (SHAQ) score, indicating subjects ability to perform daily tasks.

Scores range continuously from 0-4 representing no disability to complete disability respectively. Scores \>2 are usually considered severe disability.

The total score is computed as the mean of 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each category consists of a list of 2-3 actions. The participant selects whether they are able to perform each action "without any difficulty", "with some difficulty", "with much difficulty", or "unable to do". These selections are scored 0-4 respectively. The category is assigned the maximum score of its component actions. If the subject requires assistance from a person or device for an individual action, the minimum score for that action is 2.

Children's Hospital of Philadelphia

National Center for Advancing Translational Sciences (NCATS)

University of Pennsylvania

Financial Incentive

Control (Education)

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Dr. Marshall Strother

Number of Days Step Goal Completed

Number of Steps Taken Per Day

Protocol revised to remove this outcome. No data collected.

Composite Morbidity Outcome of Complications, Unplanned Readmissions, or Emergency Department Visits

Functional Decline as Assessed by the Stanford Health Assessment Questionnaire (SHAQ)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Psychotropic Drugs

All Drugs and Chemicals

Bupropion

Nicotine

Varenicline

Participants receive the usual care approach, Ask-Advise-Refer (AAR), which is a standard approach in which non-study clinicians ask smokers about their desire to quit smoking, advise them to quit, and provide informational resources such as hotlines, specialized clinics, or smoking cessation classes.

Participants receive the basic usual care of Ask-Advise-Refer as well as free access to nicotine replacement therapy (NRT) and/or reimbursement of up to $300 for any smoking cessation medications (varenicline/Chantix or bupropion/Zyban) prescribed by non-study clinicians.

Participants receive all aspects of enhanced usual care plus an incentive plan in which they will be informed of their eligibility to earn $100, $200, and $300 if they submit negative tests for nicotine metabolites at 2 weeks, 3 month and 6 months following their quit date, respectively.

Participants receive all aspects of Arm 3 plus an intervention to promote episodic future thinking (EFT), called FutureMe. EFT has been shown to reliably reduce discounting of the future. Patients will practice using EFT cues to envision the "future is now" between the time of enrollment and the quit date, and will then receive cues from the quit date through the end of the intervention period, 6 months later, unless they ask to stop receiving cues sooner.

Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

Removal of Financial Barriers

Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.

Episodic future thinking tool to overcome temporal discounting of future

Mobile Health Application

Shira Blady, BS

Vanessa Madden

Michael Gould, MD MS

Mohamed Ismail, MD MPH

Christine Neslund-Dudas, PhD

Michael Simoff, MD

Matthew Facktor, MD

Charlotte Collins, PhD

Scott D Halpern, MD PhD

Scott Halpern, MD PhD

Anil Vachani, MD MS

Joanna Hart, MD MS

Kevin Volpp, MD PhD

Rachel Kohn, MD MS

Dylan Small, PhD

Alisa Stephens-Shields, PhD

To compare the effectiveness of four interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among underserved smokers referred for lung cancer screening at four large U.S. health systems.

We will conduct a 4-arm randomized trial comparing 4 interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among smokers in underserved demographic groups. The 3,200 participants to be enrolled will be current smokers who are Black, Hispanic, and/or have low socioeconomic status (defined as household income \<200% of the federal poverty line or a high school education or less) or rural residence who are referred for low-dose computed tomography (LDCT) screening at 4 large health systems. All adult patients with LDCT orders will be further screened for eligibility. Eligible patients will enroll with opt-out consent and complete the study using the NIH-funded Way to Health online research portal. The primary outcome will be biochemically confirmed, sustained abstinence from smoking tobacco for 6 months following participants' selected quit dates. Relapse rates will be tracked at 12 months.

This is a prospective randomized controlled trial using opt-out consent with longitudinal follow-up of patients over 12 months. Based on the expected accrual at each of the four health systems, we expect that overall there will be 470 participants in basic usual care (Arm 1), and 910 participants in each of intervention arms 2-4.

Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

Individual participant data that underlie published results will be made available to other researchers, after de-identification.

The primary outcome measure is sustained abstinence for 6 months, and will require self-report of smoking cessation followed by biochemical confirmation at 2 weeks, 3, and 6 months.

Point-prevalent rates of self-reported nicotine use and tobacco product use

Point-prevalent rates of biochemically confirmed smoking cessation

The EuroQuol Group's quality of life (EQ-5D) scale is a 25-item validated scale used to assess patients' perceived health-related quality of life across the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The Challenges to Stopping Smoking Scale (CSS-21) is a validated 21-item measure to assess patients' perceived barriers to smoking cessation. The CSS-21 has two sub-scales: intrinsic factors (physical, psychological or cognitive aspects of quitting) and extrinsic factors (social or environmental aspects of quitting).

We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations.

The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

Temporal discounting is a measure of impulsivity that reflects people's tendencies to discount the value of a reward as a function of how far in the future it would be received. We will use the 5-Trial Adjusting Delay Task to assess temporal discounting.

Patient-Centered Outcomes Research Institute

Infections

Virus Diseases

Papilloma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Vaccines

Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination.

Staff in clinics randomized to this arm will receive the Announcement Approach Training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.

Clinics will host an Announcement Approach Training (AAT) workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own.

Communication training

Clinics will host an AAT workshop, as in the other trial arm. Clinics in the intervention arm will then receive a 12-month clinic-level financial incentive program with predetermined targets for HPV vaccine initiation rates (5%, 10%, and 30% increases from baseline). Clinics will be notified of their HPV vaccination rates though a monthly, automated report. Clinic achievement will be assessed and incentives will be paid out to clinics monthly. Incentives will be tiered based on target and sized based on the number of clinic providers. For reaching the highest tier of 30%, clinics will receive an aggregate of $1000 per provider.

financial Incentive

Kathryn R Brignole, MSc

Justin G Trogdon, PhD

This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.

The researchers will conduct a cluster randomized control trial. This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.

1:1 ratio control and intervention arm randomized controlled trial

Impact of Financial Incentives

The Impact of Clinic-level Financial Incentives on HPV Vaccine Communication and Uptake

Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.

Proportion of unvaccinated children who initiate the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.

Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.

Proportion of unvaccinated children who complete the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China	NCT06384300	Gastric Cancer	Financial Incen... Motivational In... Mixed Intervent...	40 Years - 80 Years	Peking University
Steps to Eliminate Postoperative Problems	NCT02880176	Bladder Cancer	Financial Incen...	21 Years -	University of Pennsylvania
Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening	NCT04798664	Smoking Cessati...	Removal of Fina... Financial Incen... Mobile Health A...	18 Years -	University of Pennsylvania
Impact of Financial Incentives	NCT05744960	Human Papilloma...	Communication t... financial Incen...	9 Years - 12 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for financial incentives