Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors (STELLAR)

The goal of this clinical trial is to improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients who are cancer survivors.

The main question[s] STELLAR aims to answer are:

• How best to combine three behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment.
• Evaluate the reach of the program. We will look at the number, proportion, and representativeness of participants in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity.
• Evaluate the effects of the STELLAR program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, and communication.

Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the Facilitated group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals.

Researchers will compare the Facilitated group to the Self Guided group to see if the Facilitated intervention group is able to reach more participants that enhances care only.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Obesity; Physical Inactivity
• Intervention / Treatment: Behavioral: multiple behavior change therapy

Detailed Description

The goal of this clinical trial is to decrease adverse outcomes and improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients.

The main question[s] STELLAR aims to answer are:

• How best to combine three existing effective cancer risk behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment program within the existing NMHC environment.
• Evaluate the reach of the FACILITATED program. We will look at the number, proportion, and representativeness of individuals who are willing to participate in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity.
• Evaluate the effects of the FACILITATED program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, healthcare utilization, patient-provider communication, cost and health outcomes (symptoms and quality of life).

Participants will be recruited through several channels (MyNM, direct outreach from research staff, EDW). Interested patients will then be randomly assigned to the STELLAR program arm, or Enhanced Usual Care. Participants in the STELLAR program will be enrolled for a year into the program. Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the FACILITATED group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals.

Researchers will compare the FACILITATED intervention group to the SELF GUIDED group to see if the FACILITATED intervention group is able to reach more participants that Self Guided only.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Scanlan; Phone Number: 312-503-1395; Email: laura.scanlan@northwestern.edu
• Study Contact Backup: Name: Rana Mazzetta, LMSW; Phone Number: 312-503-6595; Email: rana.khalifeh@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University-Feinberg School of Medicine
      • Contact: Bonnie Sring, Ph.D.; Phone Number: 312-908-2293; Email: bspring@northwestern.edu
      • Principal Investigator: Bonnie Spring, PhD, ABPP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Northwestern Medicine patient
• Over 18 years old
• Meet at least 1 of the following 3 criteria:
• Engage in <150 min/week of physical activity
• BMI of ≥25
• Report that they currently smoke or smoked within the last year
• Diagnosed with any cancer (except non-melanoma skin)
• Ability to attend telehealth visits either via landline, cell phone, smartphone, tablet, laptop, or desktop computer
• 3 months post curative intent treatment if BMI of ≥25 or engage in <150 min/week of physical activity
• Post curative intent treatment if they currently smoke or smoked within the last year

Exclusion Criteria:

• Currently in another dietary, weight loss, smoking cessation (including cessation pharmacotherapy), or physical activity treatment/intervention.
• Limited level of oral and written English or Spanish
• Cognitively impaired adults
• Prisoners
• Participants will be excluded from the physical activity and weight loss interventions (but not the smoking cessation component) for:
• Absolute contraindications to exercise (i.e., acute myocardial infarction, complete heart block, acute congestive heart failure, unstable angina, uncontrolled hypertension), metastatic disease or planned elective surgery
• Pregnant or plans to become pregnant.
• Individuals engaging in the physical activity or weight loss interventions must pass pre- physical activity participation screening or obtain medical clearance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FACILITATED Program; STELLAR arm participants will receive goals related to their physical activity, smoking, and/or obesity, and will be asked to meet those goals weekly/daily. Participants will also be asked to record their weight, activity, and/or cigarette smoking daily, and will complete 12 telehealth sessions with study staff across the 9 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 9 months.	Behavioral: multiple behavior change therapy; goals related to their physical activity, smoking, and/or obesity, and will be asked to meet those goals weekly/daily. Participants will also be asked to record their weight, activity, and/or cigarette smoking daily, and will complete 16 telehealth sessions with study staff across the 12 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 12 months.
No Intervention: SELF GUIDED Program; Patients in the EUC group will receive informational packets about their risk behaviors - obesity, physical inactivity, and/or smoking. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	Effectiveness will be primarily evaluated through effects on behavioral change, which will serve as the primary outcomes: For 7-day point-prevalence smoking abstinence at 6 months (self-report of any smoking even a puff in the 7 days before the 6- month follow-up visit). For continuous outcomes (e.g., weight loss) we will use linear regression models adjusting for baseline values. For moderate to vigorous physical activity, the outcome will be transformed (e.g., logarithmically) to stabilize the variance and to satisfy the normality assumption. Secondary analyses for each outcome will adjust for the number or combination of risk factors.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking	Assessed using Timeline Followback interview, participants who report any smoking, even a puff, in the 7 days prior to the visit will be classified as a person that currently smokes	baseline, 3, 6 and 9 months
Body Weight	patient reported body weight in lbs.	baseline, 3, 6 and 9 months
Self-Reported Weekly Amount (in days and minutes) of Moderate Intensity Physical Activity	Patient-reported weekly amount of moderate intensity physical activity in days and minutes will be assessed at each time point. Participants will be asked in the last 7 days, how many days they engaged in moderate intensity activity. Then on the days they were active, about how many minutes they were active (Less than 30 Minutes; 30 minutes to less than 1 hour; 1 hour to less than 1.5 hours; 1.5 hours to less than 2 hours; 2 hours to less than 2.5 hours; Over 2.5 hours)	baseline, 3, 6 and 9 months
Total Healthcare Cost and Amount of Patient Care Utilization	The following data will be extracted from the medical record: unplanned, all-cause hospital admissions; potentially avoidable, all-cause emergency department use; 7-day hospital readmissions; and use of triage clinic. Since not all patients receive all their care within the NMHC system, they will also be asked to self-report these data.	baseline, 3, 6 and 9 months
Rating of Care Quality as Measured by the Consumer Assessment of Healthcare Providers & Systems Cancer Care Survey)	Relevant subscales from AHRQ's Consumer Assessment of Healthcare Providers & Systems (CAHPS) Cancer Care Survey will be used: The specific subscales include: How Well the Cancer Care Team Communicates with Patients. This subscale asks the participant about provider communication on a 4-point scale from "never" to "always" in terms of how well the provider explained things in an easy-to-understand way, listened carefully to patient, showed respect to patient, and spent enough time with patient.; Availability of Interpreters. This subscale asks yes/no if the patient ever needed an interpreter for visits, and if yes, how often they received one on a 4-point scale from "never" to "always"; Overall Rating of Cancer Team and Cancer Care. This is a single question asking patients to rate their provider on a 1-10 scale with 1 being the worst provider possible and 10 being the best provider possible	baseline, 3, 6 and 9 months
Rating of Patient-Provider Communication and Shared Decision-Making as Measured by The Interpersonal Process of Care (IPC32)	The Interpersonal Process of Care (IPC32), will assess the patient's thoughts on physician-patient interpersonal interactions. The IPC evaluates: The patients' assessment of their physician's communication quality by asking how often physicians perform certain activities (e.g. eliciting concerns, explanations) on a scale from 1 = never to 5 = always.; The patient's assessment of how often their provider includes them in decisions about their own health (shared-decision making) on a scale from 1 = never to 5 = always.; The patient's assessment of their provider's interpersonal style based on how often the provider displayed certain behaviors (e.g. compassion, respect) on a scale from 1 = never to 5 = always.	baseline, 3, 6 and 9 months
Rating of Symptoms and Functioning as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile	The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile assesses fatigue, depression, anxiety, ability to participate in social roles and activities, sleep disturbance, physical function, and pain interference/intensity on a 1-5 rating scale with 1 being the worst rating and 5 being the best.	baseline, 3, 6 and 9 months
Rating of Quality of Life Using the Health Related Quality of Life Short Form (HRQOL SF-12)	Quality of Life will be assessed using the Health Related Quality of Life Short Form (HRQOL SF-12). The tool measures two independent dimensions of HRQOL: physical (physical functioning, role functioning, bodily pain, and general health) and emotional (vitality, social functioning, role functioning and mental health) as well as an aggregate score. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	baseline, 3, 6 and 9 months
Reach	A) We will evaluate the Reach of the risk behavior screening system by assessing the number of cancer survivors exposed to EHR screening and the proportion and representativeness of those who enroll in the study and are randomized. B) We will also evaluate the Reach of the STELLAR intervention by assessing the proportion and representativeness (in terms of disease characteristics, socioeconomic status, telehealth access, technology literacy, race/ethnicity, and insurance status) of those randomized to active intervention who attend at least one treatment session.	Baseline

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Brian Hitsman, PhD, Northwestern University; Principal Investigator: Siobhan Phillips, PhD, Northwestern University; Principal Investigator: Sofia Garcia, PhD, Northwestern University; Principal Investigator: Bonnie Spring, PhD, Florida State University

Publications and helpful links

General Publications

• Spring B, Garcia SF, Daly E, Jacobs M, Jayeoba M, Jordan N, Kircher S, Kocherginsky M, Mazzetta R, Pollack T, Scanlan L, Scherr C, Hitsman B, Phillips SM. Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):83-91. doi: 10.1093/jncimonographs/lgae020.
• Rendle KA, Tan ASL, Spring B, Bange EM, Lipitz-Snyderman A, Morris MJ, Makarov DV, Daly R, Garcia SF, Hitsman B, Ogedegbe O, Phillips S, Sherman SE, Stetson PD, Vachani A, Wainwright JV, Zullig LL, Bekelman JE. A Framework for Integrating Telehealth Equitably across the cancer care continuum. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):92-99. doi: 10.1093/jncimonographs/lgae021.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Health Behavior; Obesity; Sedentary Behavior; Smoking Cessation
• Other Study ID Numbers: P50CA271353 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified study data will be made available via a study website. Additionally, the website will contain our intervention manual and materials, templates of all study documents including the protocol, consent form, questionnaires, etc.
• IPD Sharing Time Frame: Data will become available within 1 year of completion of primary data collection
• IPD Sharing Access Criteria: Please email the principle investigator for access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No