Blood and Lymph Conditions

All Conditions

Neoplasms

Heart and Blood Diseases

Rare Diseases

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.

Exclusion Criteria

* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

We will assess whether a pen (branded, non-branded or none), a £10 cheque and/or a charity branded trolley token will affect uptake rates in the study.

GP controls will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

We will assess whether a pen (branded, non-branded or none), a £10 cheque (at study completion) and/or a charity branded trolley token will affect uptake rates in the study.

Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.

We will assess whether a pen (branded, non-branded or none) and/or a £10 cheque (at study completion) will affect uptake rates in the study. Only a limited number of trolley tokens were available so not assessed in this group.

Randomisation of branded pen, non-branded pen and no pen

Methodological pens

Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological compensation

Trolley tokens to be randomly assigned to half of cases and General Practice controls.

Methodological trolley tokens

Lesley A Anderson, PhD

There is a paucity of data on the aetiology of myeloproliferative neoplasms (MPNs). The investigators conducted a systematic review of the literature which identified several cohort and case-control studies that have investigated a wide range of potential medical, environmental and occupational risk factors. However, these studies have been limited by a wide variation in case definition and small sample sizes limiting the potential to detect modest risk differences between cases and controls. The research group propose an exploratory case-control study of 100 patients with classic MPNs and 200 controls to determine the optimal methods for roll out of this study to a multi-centred UK-based case-control study that will investigate the aetiology of MPN subtypes. The objectives of the study are to evaluate recruitment procedures, response rates and the development of a telephone administered questionnaire. The findings of this exploratory study will form the basis of a protocol for a large United Kingdom (UK)-wide case-control study of MPNs.

MPNs are a group of haematopoietic malignancies resulting from a transformed haematopietic progenitor cell. They are characterised by overproduction of mature functional blood cells. MPNs were historically termed myeloproliferative disorders and have undergone numerous amendments in classification. The 2008 World Health Organisation (WHO) classifies a number of related disorders as MPNs including polycythemia vera (PV), essential thrombocythemia (ET) and primary/idiopathic myelofibrosis (PMF)2. Reported incidence rates vary from 0.02 to 2.8 per 100,000 persons3-5 but are not well characterised with half of patients asymptomatic at diagnosis6. In Northern Ireland (NI) the prevalence of ET is reported to be 18 per 100,000 persons (by correspondence, Mary McMullin). PV and ET are indolent neoplasms with better prognosis (88% and 92% 3-year survival, respectively) compared to PMF which has a 63% 3-year survival in the United States5.

The main study objectives are to:

* Develop a telephone-based questionnaire to investigate potential risk factors associated with MPNs.
* Assess the reliability and validity of the study questionnaire.
* Determine which control group to investigate by investigating:

  * Response rates.
  * Representativeness of control groups.
* Assess recruitment procedures.
* Determine if offering reimbursement of expenses (£10 per person) encourages control participation and improved representativeness to the general population.

A case-control approach was chosen as it is the most cost-efficient method of obtaining information on the aetiology of rare diseases such as MPNs. A prospective cohort study would require participation from millions of individuals followed over a long period of time. A hospital-based approach was chosen over a population-based approach to ensure the study was more feasible and could be rolled out to a number of centres in the UK.

The disorders under investigation are:

* Polycythaemia vera
* Essential Thrombocythaemia
* Primary myelofibrosis

Initially there will be one site in Belfast, Northern Ireland and one in Southampton, England. Cases will be identified and recruited through Prof Mary Frances McMullin at the Belfast City Hospital (BCH), Belfast Health and Social Care Trust, Northern Ireland and Dr Andrew Duncombe, at the University Hospital Southampton NHS Foundation Trust (UHS), Southampton, England.

Following completion of the exploratory study it is planned that other sites across the UK will be invited to participate through the Clinical Research Network.

. CASE ASCERTAINMENT Recruitment will run over a 12 month period. It is estimated that at least 100 incident and prevalent MPN cases will be recruited from the two sites during this time frame; 50 from Belfast, NI and 50 from Southampton, England. The targeted distribution of cases projected as feasible is 40 PV, 40 ET and 20 PMF cases. Fewer PMF cases are expected as the incidence is lower than PV and ET. Both incident and prevalent cases will be recruited in the exploratory case-control study and the distribution of time since diagnosis evaluated. One of the main limitations of including prevalent cases is that risk factors may differ in those who survive for a long period after diagnosis compared to those who die soon after diagnosis. Since PV and ET have low mortality rates it is expected that this will not impact the evaluation of the aetiology of these conditions to a large extent. However for PMF, which has a higher mortality rate than PV or ET, cases will be recruited as close to diagnosis as possible.

Eligible cases will be identified by the two lead clinicians Prof McMullin (Belfast) and Dr Duncombe (Southampton) during attendance at their routine clinics. Prof McMullin and Dr Duncombe will ensure that potential cases meet the study inclusion criteria (section 2.5) and provide detailed information on the categorisation of the case (PV, ET, PMF), which diagnostic criteria have been met and the clinical history of the patient.

Patients will be invited to participate in the study by letter from their lead clinician with an information sheet. Non-respondents will be randomised to either receive a reminder letter or a telephone contact from their health care team.

The choice of control group is an important consideration in any case-control study. Controls recruited from the general population through General Practitioners, population registers, neighbourhood controls or random digit dialling are ideal at identifying a representative sample of the population from which the case population was identified. However, these groups often have low response rates and selection bias is inferably encountered. Other control groups such as friend, family or hospital controls have much higher response rates but the factors associated with friendship, family or being in hospital may mean that these groups are less representative of the general population. For the purposes of this study two control groups will be recruited; GP controls and non-blood relatives (including spouses) or friend controls. The study will investigate response rates, differences in study characteristics between control groups and generalisability to the population using population-based statistics.

2.8.1 GP Controls Within each study site 5 GPs, reflective of the geographic distribution of MPN cases, will be approached to facilitate the identification and recruitment of controls and for performing phlebotomy. Each practice will be offered £200 for participation in the study.

2.8.1.1 Northern Ireland Control Recruitment in Northern Ireland will be conducted with the help of the Northern Ireland Clinical Research Network (Primary Care) (NICRN (PC)) who work in partnership with GP practices to provide support, guidance and facilitate research. The NICRN nurses who work with practices hold a Confidentiality Agreement and honorary contract with the practice. Practices are supplied with a study file, which is kept in a secure location at the practice and contains the study protocol and all relevant study information including the completed Research Governance form and contact details of researchers and NICRN (PC) staff.

With prior arrangement and agreement with the practice partners the research nurse will make an appointment with the practice manager (PM) who will either facilitate practice staff to conduct a computer search to randomly select potential controls or supply the nurse with their own unique user name and password to do so. The search will be conducted using the practice computer system's inbuilt randomisation programme, based on a numbered list of age and gender-matched patients (approximating 2 per MPN case, calculated on the basis of an attrition rate of 40-50%). The GP will be asked to confirm the eligibility of each potential control patient prior to them receiving study information from the practice.

Study information will be mailed to eligible control patients from the practice on practice headed paper and with a letter, signed by the GP, inviting them to participate. In order to track patient replies, each envelope will have a unique code number written on the front. A patient tracker form with the unique code number written beside the relevant name on the list of control patients is kept in the practice study file to track responders and non-responders for follow up purposes. No patient identifiable data will be removed from the practice at any time.

Non-respondents will be randomised to either receive a reminder letter approx two weeks after the first mail shot or to have a telephone call from practice staff using the follow-up telephone transcript.

2.8.1.2 Southampton The research nurse in Southampton will work in partnership with GP practices to provide support, guidance and facilitate research. An honorary contract and confidentiality agreement will be arranged with the practices.. This will include the nurses NMC number and copies of GCP training certificates. Practices are supplied with a study file, which is kept in a secure location at the practice and contains the study protocol and all relevant study information including the completed Research Governance form and contact details of researchers and NICRN (PC) staff.

With prior arrangement and agreement with the practice partners the research nurse will make an appointment with the practice manager (PM) who will either facilitate practice staff to conduct a computer search to randomly select potential controls or supply the nurse with their own unique user name and password to do so. The search will be conducted using the practice computer system's inbuilt randomisation programme, based on a numbered list of age and gender-matched patients (approximating 2 per MPN case, calculated on the basis of an attrition rate of 40-50%). The GP will be asked to confirm the eligibility of each potential control patient prior to them receiving study information from the practice.

Study information will be mailed to eligible control patients from the practice on practice headed paper and with a letter, signed by the GP, inviting them to participate. In order to track patient replies, each envelope will have a unique code number written on the front. A patient tracker form with the unique code number written beside the relevant name on the list of control patients is kept in the practice study file to track responders and non-responders for follow up purposes. No patient identifiable data will be removed from the practice at any time.

Non-respondents will be randomised to either receive a reminder letter approx two weeks after the first mail shot or to have a telephone call from practice staff using the follow-up telephone transcript.

2.8.2 Relative/Friend Controls Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older. Controls meeting the exclusion, section 2.7, will not be eligible for participation. Controls will not be individually matched to cases but must reside in the study area (Belfast or Southampton). Blood relatives will not be eligible for participation. Partners or friends MPN cases attending outpatient appointments in Belfast City Hospital or UHS will also be approached to participate in the study as study flyers will be available. A reminder to follow-up with recruitment of non-blood relatives/controls will be undertaken at the time of telephone interview with the cases. Those interested in participating in the study can contact the study team for the information sheet, consent form and other documentation by completing the tear off contact details strip on the flyer and posting (in the FREEPOST envelope that will be attached to the flyer) to the study team or by telephone or e-mail.

INFORMED CONSENT All cases and controls will be contacted by letter with a patient information leaflet, a consent form, patient contact form and work/residence history calendar. A pen will be included in the envelope in addition to a MPD Voice charity information sheet and a trolley token (for 50% of cases and controls). The number of subjects who refuse to participate will be documented. Subjects who refuse to participate at telephone contact will be asked whether they are willing to answer a short questionnaire to assess the representativeness of the recruited subjects. Subjects will be given the opportunity to withdraw from the study at any time however the information provided up to that point will be retained and used within the study. Subjects will be asked for verbal consent at time of telephone interview to have the interview recorded both before and after (if agreeable) the recording device is activated.

Venous blood sample (up to 12 ml) - whole blood, DNA Saliva (2ml) Dried Blood spots (500 µl) Toe-nails (2 great toe-nail clippings)

Myeloproliferative Neoplasms: an In-depth Case-control Study

Researchers can contact the study lead (Dr Anderson) to request a data access form. Once a data access form has been completed it will be reviewed by the study team and a decision made. If sharing of data has been agreed by the study team the contracts department and legal teams will review the proposed sharing of data to ensure that it meets with international standards.

* Difference in participation rates in those receiving:
* vs. not receiving a pen at initial contact.
* vs. not receiving a trolley token at initial contact.
* vs. not receiving a monetary incentive at initial contact.
* a MOSAICC pen vs. a non-branded pen following second contact.
* vs. not receiving a trolley token following second contact.
* a MOSAICC branded Pen +/or trolley token alone vs no non-monetary incentive following a second invite.
* a MOSAICC branded Pen +/or trolley token alone vs no incentive following a second invite.
* a MOSAICC branded Pen +/or trolley token alone vs pen/no pen \&/or money following a second invite (branded vs unbranded incentive)
* 0/1 of these incentives vs. receiving 2/3 incentives following a second invite.
* Difference in proportion of patients completing study elements comparing:
* 0/1 vs 2/3 incentives.
* those receiving pre vs post invitation incentives.

University Hospital Southampton NHS Foundation Trust

University of Manchester

Western Australian Institute for Medical Research

Mayo Clinic

Queen's University, Belfast

Chief Investigator

Adverse Events were not collected/assessed

Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.

Exclusion Criteria

* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological trolley tokens: Trolley tokens to be randomly assigned to half of cases and General Practice controls.

Myeloproliferative Neoplasm Case

For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".

General Practice Control

Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Non-blood Relative or Family Control

The letters inviting participants to participate in the study were randomised to contain:

* a branded pen, an unbranded pen or no pen
* a trolley token
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.

The letters inviting participants to participate in the study were randomised to contain:

* a branded pen, an unbranded pen or no pen
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.

Non-blood Relative Family Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United Kingdom

Region of Enrollment

Dr Lesley Anderson

No. of Participants who didn't receive an incentive

No. of participants who got pen - INITIAL CONTACT

No. participants got TrolleyToken- INITIAL CONTACT

No. participants got compensation -INITIAL CONTACT

No. who got Mosaicc pen- INITIAL CONTACT

No. who got Normal pen-INITIAL CONTACT

No. who got Pre-incentive (pen and/or trolley token) only- INITIAL CONTACT

No. who got compensation only- INITIAL CONTACT

No. who got pre & post incentive e.g. pen, trolley token and compensation - INITIAL CONTACT

No. of participants who got 0 or 1 incentive- INITIAL CONTACT

No of participants 2or 3 incentives(F/F controls could only receive a max of 2 incentives) - INITIAL

No who participated after the second invite

No of participants after second invite who initially received a MOSAICC pen

No of participants after second invite who initially received a Normal pen

No of participants after second invite who initially received a Trolley token

For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.

The following patient groups will be excluded. Those:

* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".

Methodological pens: Randomisation of branded pen, non-branded pen and no pen

Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study

Methodological trolley tokens: Trolley tokens to be randomly assigned to half

Influence of Pre- and Post- Incentives on Participation Rates.

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $10 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $20 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will have a 1 in 10 chance of being mailed a voucher that can be exchanged for $50 at PVAMC.

In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be entered into a raffle in which 1 randomly chosen patient (out of about 100 patients) will be mailed a check in the amount of $500.

Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to.

Stage 1

Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to. The exact dollar amounts for the Voucher-Based Incentive, Lottery-Based Incentive, and Raffle-Based Incentive arms will be based on the results of Stage 1.

Stage 2

Jeffrey T Kullgren, MD, MS, MPH

Steven C Marcus, PhD

This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial incentives directly integrated into primary care can improve fecal occult blood test (FOBT) completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care, $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of FOBT completion. We also hypothesize that there will be a direct dose-response relationship between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a statistically significant increase in the rate of FOBT completion compared to a fixed payment incentive with an equivalent dollar per patient value.

Improving Fecal Occult Blood Test Completion Rates Among Veterans

There are 2 secondary outcomes. First, we will compare time to FOBT kit return by arm. Second, we will compare 30 day FOBT completion rates among previously non-adherent patients (i.e., individuals who had failed to complete a prescribed FOBT kit in the year prior to the start of the study) by arm.

VA Pittsburgh Healthcare System

Corporal Michael J. Crescenz VA Medical Center

Principal Investigator

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values.

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values.

Participants will be in the form of a charitable donation in their name to a cancer charity.

Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals). They will also receive a donation to a cancer charity of their choice if they meet daily step goals.

Experimental

Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals).

Control

The investigators propose to examine whether linking daily activity with charity-based incentives motivates cancer survivors to initiate and maintain physical activity. Linking daily physical activity goals with a cancer specific charity incentive may provide a uniquely salient motivator that promotes increased physical activity among cancer survivors. The investigators will examine whether using activity monitors in combination with charitable incentives leads to greater increases in physical activity compared to activity monitors alone. Target participants includes cancer survivors who are not already active. Physical activity (e.g., steps per day, time in moderate-intensity activity) will be examined at baseline and following a 12-week intervention period using an activPAL accelerometer. After the baseline assessment, both groups will receive a fitbit monitor and informational material designed to increase physical activity. Participants in the fitbit+charity group will have donations made in their name to a cancer charity if they meet daily step goals. Physical activity levels will be monitored using the fitbit device for 6-weeks following the formal intervention period.

The study is a Randomized Controlled Trial (RCT) of a 12-week physical activity intervention. Fifty cancer survivors will be recruited and allocated to one of two research arms: Fitbit+Only Group or Fitbit+Charity Incentives Group. Participants in both intervention arms will be asked to track their physical activities using Fitbit One, an activity monitor that monitors steps and physical activity and will receive basic educational materials about increasing physical activity. Those in the Fitbit+charity incentives Group will raise money for cancer charities if they meet weekly step targets.

The key outcome variable of the RCT is steps as measured by an activPAL accelerometer. Data will be collected at baseline and 12-weeks. Fitbit data will also be collected for the duration of the 12-week intervention and for 6-weeks following the end of the intervention period to have an initial examination of behavior change maintenance (total 18-weeks).

Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity

Randomized Trial of Charity-based Incentives to Increase Physical Activity Among Cancer Survivors

Proportion of participants retained of those randomized

Proportion of individuals who agree to participate of those who express an interest in participation

Proportion of weeks meeting physical activity goal as measured by fitbit

Sedentary time as Measured by activPAL activity monitor

Sedentary breaks/patterns as Measured by activPAL

Patient-Reported Outcomes Measurement Information System Fatigue Short Form 8a (Total Score range 8-40). higher score is more fatigue.

Patient-Reported Outcomes Measurement Information System Physical Function Short Form 20a. Total score (range 20-100). Higher score is worse physical function

Patient-Reported Outcomes Measurement Information System Depression Short Form 8a. Total score range 8-40. Higher score is more depressed.

Attitudes Toward Charitable Giving Scale. Total of 20 questions with scores from 1-5, there are five domains higher score is more of a particular attitude. 1.) Inefficiency of Charitable Giving 2.) Efficiency of Charitable Giving 3.) Cynical Giving 4.) Altruistic Giving 5.) Purpose of Charity

Behavioral Regulation in Exercise Questionnaire -3. Contains 6 subscales Amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, intrinsic regulation, each range from 0-16, higher values indicate more motivation in that domain.

Barriers Self-efficacy Scale. 15 items, total score range 0-1500. Higher indicated more self-efficacy

Physical Activity Enjoyment Scale. 18-item scale with 7-point bipolar rating. Total score range 18-126. Higher scores reflect greater levels of enjoyment.

Pittsburg Sleep Quality Questionnaire. Total score. Greater than 5 indicated poor sleep quality.

Exercise Self-efficacy Scale. 6 items total score. Range 0-600, higher is more self-efficacy

% of weeks adhered to step goal as measured by fitbit during 6-week follow-up period

Duration wore Fitbit during during 6-week follow-up period

Multidimensional Outcome Expectations for Exercise Scale. Total score (range 15-75), higher score means more multidimensional outcome expectations.

Patient-Reported Outcomes Measurement Information System Sleep Disturbance Form. Total score range 8-40. Higher score is more disturbance.

10-item total score. Ranged from 10 to 50, higher score means more goal setting. Exercise Goal-Setting Scale.

California Polytechnic State University-San Luis Obispo

Assistant Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Psychotropic Drugs

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.

Financial Incentives

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Myeloproliferative Neoplasms: an In-depth Case-control Study	NCT01831635	Polycythemia Ve... Essential Throm... Primary Myelofi...	Methodological ... Methodological ... Methodological ...	18 Years -	Queen's University, Belfast
Improving Fecal Occult Blood Test Completion Rates Among Veterans	NCT01516489	Colorectal Canc...	Stage 1 Stage 2	-	Corporal Michael J. Crescenz VA Medical Center
Improving Fecal Occult Blood Test Completion Rates Among Veterans	NCT01516489	Colorectal Canc...	Stage 1 Stage 2	-	Corporal Michael J. Crescenz VA Medical Center
Evaluating Whether Charity Incentives Motive Cancer Survivors to Increase Physical Activity	NCT03322059	Cancer Physical Activi... Incentives	Experimental Control	18 Years - 50 Years	California Polytechnic State University-San Luis Obispo
Myeloproliferative Neoplasms: an In-depth Case-control Study	NCT01831635	Polycythemia Ve... Essential Throm... Primary Myelofi...	Methodological ... Methodological ... Methodological ...	18 Years -	Queen's University, Belfast
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

Spots Global Cancer Trial Database for incentives

Every month we try and update this database with for incentives cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for incentives

Every month we try and update this database with for incentives cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for incentives cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.