Symptoms and General Pathology

All Conditions

Weight Loss

Body Weight

Body Weight Changes

Everyone in the study will receive the same type of treatment. They will all receive a treatment period that will last for 8 weeks. All participants will be given a 3% total weight loss goal, a daily calorie goal ranging from 1200-2000 kcal/day based on body weight, and a daily fat goal based on 25% of total daily calories from fat, and an option to stop their food/energy intake at 6pm every day without altering any other meal times. .Participants will also be asked to use two meal replacements per day. Participants will also be given a physical activity goal of 100 minutes per week.

All participants will receive a weight loss intervention that includes 8 coaching sessions guided by a workbook they will at their baseline visit. During these sessions, they will meet with a health coach individually for up to 10-15 minutes via telephone or video conference to learn and discuss weight loss strategies. Health coaches will provide feedback and instruction (by phone or email) based on progress and challenges encountered during the intervention. Participants will receive a weight management app custom-built for the research study. The app will display participants' dietary intake, physical activity, and weight data and goals on the smartphone, and participants will use the app to log dietary intake, physical activity, and weight daily.

Interventional Behavioral Arm

The purpose of this study is to test a new weight loss intervention designed for cancer survivors who have heart disease or cardiometabolic conditions. The investigators want to determine whether this study is feasible and acceptable to participants. The investigators also want to learn more about how cancer survivors take their medications.

The purpose of this study is to test a new weight loss intervention designed for cancer survivors. The investigators want to determine whether this approach to weight loss is feasible and acceptable to cancer survivors. All participants in the study will receive free behavioral telephone-based weight loss management in the Department of Preventive Medicine at Northwestern University. Participants must be willing and able to use their smartphone with Bluetooth and their WiFi to download Apps, set up a Fitbit account and a Google account if not already set up. Participants will use their smartphone to record food intake \& physical activity over an 8 week weight loss program. This program includes recruitment of a "Buddy" that the participant will choose to support you during the 8 week study.

All participants will be asked to download a study application to use to record dietary intake each day during a "Run-In Week.". Eligible participants will then receive an 8-week weight loss program, including individual weekly sessions with health coaches. The investigators will also ask participants to complete both a baseline and follow-up session with study staff. If permitted by current university policies, these sessions will be held at the offices on Northwestern University's Chicago campus. Otherwise, these sessions will be conducted remotely via Zoom videoconference. If this is the case, as a privacy safeguard, the waiting room feature will be applied so that study staff can control who is admitted into the meeting. We expect that the participants will be in this research study for about 10 weeks.

The primary risk of participation is muscle soreness or injury from increased physical activity, as well as feelings of hunger from making changes to diet. The main benefit is that a participant may experience positive changes to their health and mood based on the study.

To explore individual differences in responses to the weight loss intervention as well as mechanisms underlying its effects, additional survey measures will be administered. These measures will include: demographics, other health information, motivations for losing weight (TSR-Q), personality (BFI-10), chronic stress (Life Events Inventory) perceived stress (PSS-10), stress in past week, the positive and negative affect scale, PROMIS scale of cognitive function PROMIS scales of physical function, PROMIS scales of mental health, PROMIS scales of social health, fear of cancer recurrence, and self-efficacy for diet and exercise. PROMIS items will be assessed using computerized adaptive testing versions with items drawn from banks specific to the individual constructs assessed.

M-POWER Feasibility Study

Mobile - PrOmoting Wellness After cancER Study: M-POWER Feasibility Study

Weight will be measured in the lab at baseline and then the change in weight at the follow-up. Baseline measurements occur one week before the study and follow up measurements occur at week 8 of the study. Measurements will be taken without shoes, wearing light clothing on a calibrated beam balance scale called the Aria Scale.

For melanoma patients only, skin self-examination frequency will also be assessed.

Height will also be measured using a stadiometer.

Northwestern University

Professor of Preventive Medicine

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Myeloproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Chronic Myeloproliferative Disorders

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The main purpose is to assess adherence to ruxolitinib using the ARMS questionnaire. Each individual patient will be administered the questionnaire at the first convenient opportunity, regardless of when ruxolitinib is started, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement.

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histologic, cytogenetic, molecular, and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular, data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. These data will be collected at the first administration of the ARMS questionnaire and again after 12, 24, and 48 weeks. If performed, any additional assessments will also be recorded. Each individual patient will be administered the questionnaire (ARMS) at the first convenient opportunity, regardless of the time of initiation of ruxolitinib, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement. If in-person data collection is not possible, the mode of data collection by telephone interview will be adopted. The minimum expected duration of individual patient observation is 48 weeks.

Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence

Emotional distress is measured based on a visual analogue scale with the distress thermometer, a simple and quick (3-4 minutes) tool that investigates the areas most involved in distress (minimum value: 0, lower distress; maximum value: 10, higher distress)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

1. Patient survivorship education via telehealth with the cancer center
2. Ongoing patient-tailored education program by MyChart within the EHR patient portal
3. Structured interactive phone communication between the research RN at the cancer center and community PCP clinic
4. In-person visit with the PCP clinic for survivorship care.

In-person visit at specialty survivorship clinic

1) Patient survivorship education via telehealth with the cancer center- The research registered nurse (RN) will discuss the contents of the survivorship care plan and coordination between the cancer center and PCP clinic. 2) Ongoing patient-tailored education program by MyChart within the EHR patient portal- Patients will be asked to select survivorship topics of interest from a panel (e.g. school issues, fertility, fatigue, physical activity, single kidney health, emotions/coping) that will then be sent over 1 year. 3) Structured interactive phone communication between the research RN at the cancer center and community PCP clinic- The discussion will explain the patient's cancer history, tumor recurrence monitoring schedule, individualized risk of late effects and surveillance schedule, psychosocial challenges, health behaviors, and coordination between the cancer center and PCP clinic. 4) In-person visit with the PCP clinic for survivorship care.

Multi-level Intervention of shared model of survivorship care

Participants will be contacted by study staff at their cancer center to schedule an in-person visit at the survivorship clinic that will include a comprehensive history focused on cancer-related medical and psychosocial issues, physical examination, ordering of recommended surveillance for late effects, and delivery of hard copy of their survivorship care plan.

Comparison Group

Nina Kadan-Lottick, MD, MSPH

Jacqueline Casillas, MD

Jenna Demedis, MD

Burton Appel, MD

Andrew Smitherman, MD

More than 80% of childhood cancer survivors develop serious or life-threatening late effects after cancer therapy, but \<20% receive recommended survivorship care offered at cancer center survivorship clinics. In a shared care model, the investigators propose to investigate an innovative multi-level intervention consisting of: 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the electronic health record patient portal, 3) a structured interactive phone communication between the cancer center and the primary care clinic, and 4) an in-person visit with the primary care clinic for survivorship care with the goal of achieving high rates of adherence to recommended surveillance for late effects, as well as improving patient and physician knowledge and self-efficacy. If this scalable intervention demonstrates patient completion of recommended care comparable to cancer center survivorship clinics, this innovative study has the enormous potential to deliver recommended care to a larger proportion of childhood cancer survivors and reduce survivorship care disparities, while engaging p to integrate survivorship care as part of overall, lifelong health maintenance.

More than 80% of childhood cancer survivors (CCS) develop serious or life-threatening late effects. Yet \<20% of CCS receive recommended survivorship care, despite the availability of consensus guidelines for lifelong surveillance for late effects starting 2 years post-therapy. The "gold standard" cancer center-based survivorship clinic provides high-quality care to CCS who attend, but patients avoid reminders of their past cancer and lack knowledge and self-efficacy for survivorship care. Other barriers include travel distance, inadequate insurance, and out-of-pocket costs-these structural issues contribute to health disparities. Partnering with community primary care provider (PCP) clinics in a shared model of care is a promising strategy to overcome these barriers, but PCPs lack knowledge, self-efficacy, and interactive communication with the cancer center and are confused about the division of care responsibilities. This intervention is scalable and distance-based, is informed directly by patient and PCP barriers and preferences from previous studies, and is boosted by a nationwide explosion in telehealth services precipitated by the COVID-19 crisis. The proposed randomized controlled trial will enroll 240 CCS 2.0-4.0 years post-chemotherapy/radiation to investigate an innovative multi-level intervention (i.e., interpersonal and organizational levels) consisting of 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the electronic health record (EHR)'s patient portal, 3) a structured interactive phone communication between the cancer center and the PCP clinic (with 1-year follow-up call), and 4) an in-person visit with the PCP clinic for survivorship care. The comparison group will be randomized to an in-person visit with their cancer center survivorship clinic. This study includes 4 centers with high proportions of subgroups vulnerable to survivorship care disparities (i.e., rural, Black, Latinx, Spanish-speaking, socioeconomically disadvantaged). Both groups will be asked to begin recommended surveillance for late effects within 1-year post-randomization, separate from tumor recurrence monitoring by the primary oncologist. The Specific Aims are to Aim 1- Demonstrate patient completion of guideline-recommended surveillance tests in intervention participants is not inferior, i.e. within 10%, to that in the comparison group; Aim 2- Achieve greater 1) patient knowledge, self-efficacy, and activation and 2) PCP knowledge and self-efficacy with survivorship care among intervention participants and their PCPs compared to the comparison group; and Aim 3- Ascertain process outcomes for the 1) patient and 2) PCP clinic. Outcomes will also be assessed among subgroups with survivorship care disparities. Transformative Impact: If the intervention demonstrates patient completion of recommended survivorship care comparable to cancer center survivorship clinic, the study has the enormous potential to deliver recommended lifelong care to a larger proportion of CCS and reduce survivorship care ies, while engaging patients and PCPs to integrate survivorship care as part of overall, lifelong health maintenance.

A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

BRidging Information Divides and Gaps to Ensure Survivorship: the BRIDGES Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

The proposed research will include data from 240 survivors of childhood cancer. The dataset will include (1) demographic data; (2) cancer diagnosis and treatment data; (3) adherence to survivorship care data; (4) knowledge, self-efficacy, and activation data; and (5) process outcomes (feasibility, fidelity, acceptability) data. In compliance with the National Institutes of Health Principles and Guidelines document, the investigators will readily provide all relevant protocols, publications, and the underlying primary data (to the extent possible as guided by the IRB) supporting publications to other academic investigators upon request. To maintain the privacy of the human subjects, data will de-identified. Should any intellectual property arise that requires a patent, the investigators will ensure that the technology (materials and data) remains widely available to the academic research community.

The investigators will conduct semi-structured, qualitative interviews with 1) 40 intervention participants and 2) 40 PCP clinics to generate feedback regarding the intervention (e.g. timing, duration, usability). Interviews will explore acceptability of the intervention and how to improve intervention efficacy.

The investigators will assess adherence to surveillance recommended by the Children's Oncology Group Long-term Follow-up Guidelines. The primary analysis will be on tests completed by patients, and not just ordered by physicians, because that is the most meaningful indicator of patient adherence to guidelines

Patient Knowledge Survey developed by Kadan-Lottick et al. for the Childhood Cancer Survey Study which is a 9-item survey regarding treatment history, risk of late effects, need for survivorship care, and purpose of the survivorship care plan. Note that results will not be reported on a scale.

Patient Knowledge Survey developed by Kadan-Lottick et al. for the Childhood Cancer Survey Study which is a 9-item survey regarding treatment history, risk of late effects, need for survivorship care, and purpose of the survivorship care plan. Note that results are not reported on a scale.

Stanford Chronic Disease Self-Efficacy Scale (score range 1-10, higher score indicates greater self-efficacy) to be administered to patients and proxies

The 13-item Patient Activation Measure (PAM) will be administered to participants to evaluate the level of patient activation, i.e. patient self-reported knowledge, skill, and confidence for self-management of one's health or chronic condition. Scores range from 0-100 with higher scores reflecting greater patient activation.

Survey consisting of questions regarding the PCPs' familiarity with the surveillance guidelines and confidence in providing survivorship care. Note that results are not reported on a scale.

Patients will complete a survey regarding process outcomes (i.e., feasibility, fidelity, acceptability) associated with the multi-level intervention. Note that results are not reported on a scale.

Primary care physicians will complete a survey regarding process outcomes (i.e., feasibility, fidelity, acceptability) associated with the multi-level intervention. Note that results are not reported on a scale.

University of North Carolina, Chapel Hill

University of Colorado, Denver

Hackensack Meridian Health

NYU Langone Health

Seattle Children's Hospital

Georgetown University

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up.

Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up

Clinicians in this arm will not be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up.

Patients will receive usual care.

Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up.

Clinicians will receive usual care.

Patients and clinicians in this arm will receive usual care.

Brief persuasive messaging to increase awareness about the importance of annual lung cancer screening and completion of recommended follow-up sent to patients via text message.

Patient Nudge

EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.

Clinician Nudge

Katharine Rendle, PhD,MSW,MPH

Jocelyn Wainwright, MS

Hannah Toneff, MSW, MA

Anil Vachani, MD

Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) \& diagnostic follow-up across eligible primary care clinicians \& patients. Following the trial, a subsample of patients \& clinicians will be invited to one-time semi-structured interview \& survey to identify individual \& system-level factors that may restrict or enhance the impact of strategies.

Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with clinicians that provide care to screening-eligible patients who are overdue for annual screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1) gain-framed messaging delivered via text messaging to prompt patient adherence to LCS guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting clinicians when their patients are due for annual screening or diagnostic follow-up (clinician nudges). The rationale for this study is that changing external stimuli to encourage adherence to evidence-based LCS guidelines will increase early detection of lung cancer by removing individual and system-level barriers to identifying and prompting patients who are due for care. The central hypothesis is that the combination of patient and clinician strategies will have the greatest effect on increasing adherence because it will target multilevel determinants of lung cancer screening identified in our prior research including limited screening knowledge and suboptimal EHR design. The proposed strategies are designed to support equitable implementation across diverse settings and populations.

At the start of the trial, clinicians who do not opt-out will be randomized to the intervention (clinician nudge) or control arm (no clinician nudge). Eligible patients will be randomized, stratified by clinician, to either the intervention (patient nudge) or control group (no patient nudge).

Increasing Adherence to Lung Cancer Screening

Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up

Defined as having a positive LDCT and no subsequent lung cancer diagnosis within 6 months of the LDCT date

Biopsy confirmed lung cancer diagnosis measured using EHR data

Number of completed low-dose computed tomography (LDCT) scans among adults who are due for annual screening based on evidence-based guidelines.

Completion of recommended diagnostic follow-up scans or procedures among adults with positive baseline LDCT scan.

Reach defined by proportion of patients who receive patient nudges and by the proportion of patients whose clinician acts upon clinician nudge (i.e., signs pended orders)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
M-POWER Feasibility Study	NCT05921565	Weight Reductio... Adherence, Pati...	Interventional ...	18 Years - 84 Years	Northwestern University
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera	NCT06078319	Adherence, Pati... Adherence, Trea...		18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship	NCT05448560	Childhood Cance... Survivorship Health Care Uti... Health Knowledg... Adherence, Pati...	Multi-level Int... Comparison Grou...	2 Years -	Georgetown University
Increasing Adherence to Lung Cancer Screening	NCT05832008	Lung Cancer Adherence, Pati...	Patient Nudge Clinician Nudge	50 Years - 80 Years	Abramson Cancer Center at Penn Medicine
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera	NCT06078319	Adherence, Pati... Adherence, Trea...		18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna

Spots Global Cancer Trial Database for adherence, patient