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

Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Overweight

Obesity

Body Weight

Weight Loss

Overnutrition

Nutrition Disorders

Body Weight Changes

Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to under-served population groups

Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support

The 3 major intervention components are diet, physical activity, and the behavioral modification curriculum. Scheduled interactions are educational podcasts (a series of audiovisual, digital media files) paired with a follow-up phone counseling session with a trained behavioral interventionist. A patient portal message will be sent to participants when a new podcast is posted. Interactive sessions will be weekly (weeks 1-16), biweekly (weeks 17-24), and monthly (weeks 25-52). The goal for weight loss is ≥ 7% of initial weight over the course of 12 months. Participants will restrict caloric intake with the goal of 1,200-1,500 kcal/day for those weighing \< 114 kg and 1,500-1,800 kcal/day for those weighing ≥ 114 kg. The physical activity goal will be for participants to gradually increase to 175-200 minutes of moderate-intensity activity per week by the 24th week. Participants will also be asked to self-monitor their dietary intake and physical activity using the "Lose It!" app.

Active Intervention Group

All participants in the Comparison Group will receive a mandatory 13 contacts per year including 3 informational sessions on nutrition, physical activity and social support and 10 contacts via patient portal or email regarding intervention topics. The Look AHEAD Comparison Group was designed to be realistic, achievable, and an acceptable intervention that encouraged optimal study retention.

Julia Graber

Karen Johnson, MD

Karen C. Johnson, MD, MPH

The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD\* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for underserved groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group.

\*The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE).

This research project is a collaborative effort between the University of Tennessee Health Science Center (UTHSC) and Regional One Health, one of the largest nonprofit physician practice groups located in western Tennessee and in the surrounding rural areas - part of the Delta area with some of the highest rates of obesity in the nation. Obesity and excess body fat are associated with many diseases and adverse health consequences. Obesity is associated with an increased risk of morbidity and mortality from cancer and may worsen cancer survivorship and quality of life. Obesity also disproportionally affects underserved population groups such as racial and ethnic minorities, persons with lower socioeconomic status, and persons living in rural areas. Although numerous research studies have shown that behavioral weight loss interventions combined with dietary modification and increased physical activity are the most effective in achieving weight loss and guidelines have endorsed such interventions, there is limited literature describing behavioral weight loss strategies in real-world clinical practice settings. There are also no published studies on the effectiveness of practice-based, multicomponent behavioral interventions for weight loss in underserved populations in urban or rural settings, using Health IT and the EHR patient portal. The investigators of this study propose a practice-based clinical trial delivering the intervention via the Health IT EHR patient portal combined with supportive telephonic follow-up that specifically addresses the concerns and needs of underserved populations living in either an urban or rural area. If successful, this intervention would demonstrate an approach that could be applicable to challenging populations and would demonstrate how to develop, implement, and sustain an effective weight loss intervention integrated within a trusted healthcare system's Health IT that may prevent cancer. During Stage 1 (12 months), the investigators will refine the intervention for Health IT delivery by conducting formative research (key informant interviews and focus groups). With patients, they will seek to identify the barriers to implementing the Look AHEAD ILI behavioral weight loss intervention and adapt and modify ILI components to make them acceptable for underserved populations in both urban and rural settings and integrate those components into the EHR patient portal (Active Intervention group). The investigators will also adapt the Look AHEAD Comparison condition (DSE group) for the Comparison condition. With healthcare providers, the study team will seek to determine how a Health IT intervention integrated at the system level, can facilitate delivery of guideline concordant weight management care. During Stage 2 (years 2-5), the investigators will conduct a clinical trial and randomly assign 250 participants at the Regional One Health partner practice sites in urban and rural settings in a 1:1 ratio to either the Comparison Group or the Active Intervention Group and determine weight change (primary outcome) over time in both groups. In this study, investigators will also assess how social determinants of health are related to patient uptake and engagement with the Health IT patient portal and patient success with weight loss.

This is a 2-arm, parallel, randomized, controlled clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to either a behavioral weight loss intervention group delivered via Health IT with telephonic support (Active Intervention Group) or the Comparison Group. Because intervention delivery does not depend on clinic site, the study team has opted for a more powerful individual randomization over cluster randomization (but the team will potentially include clinic site as a grouping effect in the analysis).

The randomized portion of this protocol will employ a blinding design so that the CHAMPS study personnel and investigators who are collecting and assessing outcome data (i.e., weight) will not know a participant's group assignment status (blinded to assignment). Neither the participants, nor the study staff who provide the intervention, will be blinded to assignment. All participants will be asked not to reveal their CHAMPS study group assignment to blinded clinic personnel. All intervention-related information will be kept separately from outcome data and will not be accessible to blinded staff.

Choosing Healthy Activities and Lifestyle Management Through Portal Support

Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk

Investigators will prepare and distribute a dataset maintaining confidentiality of individual participants. The final study analytical database will be processed according to HIPAA definitions for public data sharing and participant data will be de-identified using processes such as: removal of identifiers, translation of dates and ages to delta time values, and assignment of random study identifiers. A series of de-identified data files representing the final analytical data set will be available and provided in a standard format that is readable across a variety of applications and operating system platforms. Other documentation may include: data dictionary, data code book, valid variable ranges, protocol, MOP, intervention manual or programs, and any electronic versions of any paper forms that were used. The data release documentation will provide detailed, organized documentation of study variables and clear instructions on how to install and access the data.

This is calculated for each follow-up visit as ((weight at FU visit - baseline weight) / (baseline weight)) × 100%.

How social determinants of health, assessed via the Social Needs Screening Tool, relate to patient success with weight loss

How social determinants of health, assessed via the Social Determinants of Health Questions Adapted from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 Questionnaire, relate to patient success with weight loss

How social determinants of health, assessed using z codes for Social Determinants of Health constructs abstracted from the Electronic Health Record using ICD -10 codes, relate to patient success with weight loss

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Choosing Healthy Activities and Lifestyle Management Through Portal Support	NCT05410353	Weight Loss Overweight and ... Behavior, Healt...	Active Interven... Comparison Grou...	16 Years -	University of Tennessee
Choosing Healthy Activities and Lifestyle Management Through Portal Support	NCT05410353	Weight Loss Overweight and ... Behavior, Healt...	Active Interven... Comparison Grou...	16 Years -	University of Tennessee

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