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

{ "The STELLAR Program: Improving Health for Cancer Survivors", "This study, called the STELLAR Program, is for Northwestern Medicine patients who have had cancer. It aims to improve your health, survival, and quality of life by helping you change behaviors that can increase cancer risk, such as obesity, smoking, and not being physically active. The study will test a program that combines support for physical activity, quitting smoking, and managing weight through telehealth sessions. We want to see how well this program works over 6 months and how many different types of people it can help. To join, you must be over 18, a Northwestern Medicine patient, have had cancer (not skin cancer), and meet at least one of these criteria: you're not very active, have a BMI (body mass index) of 25 or higher, or currently smoke or smoked within the last year. You also need to be able to attend telehealth visits.", "design": "This interventional study plans to enroll 1500 participants. You will be randomly assigned to either the STELLAR program or enhanced usual care (receiving information).", "commitments": "If you are in the STELLAR program, you will set weekly/daily goals for physical activity, smoking, and/or weight, and record your progress daily. You will also complete 16 telehealth sessions with study staff over 12 months.", "compensation": "Not stated in the trial record.", "follow_up": "The effectiveness of the program will be measured at 6 months.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05687604

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

Recruiting
NAAges 18+InterventionalTreatment
Northwestern University
~1,500 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:multiple behavior change therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness
Measured over 6 Months
Obesity
Smoking Cessation
Physical Inactivity
1 sites across 1 states
Illinois1
  • Brian Hitsman, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Sofia Garcia, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Siobhan Phillips, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Bonnie Spring, PhD · PRINCIPAL_INVESTIGATOR · Florida State University

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Eligibility criteria

Inclusion

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

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
  • Effectiveness6 Months

    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.