Recruiting

Cancer Care

Sponsor:

Northwestern University

Code:

NCT05687604

Conditions

Obesity

Smoking Cessation

Physical Inactivity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

multiple behavior change therapy

Study Details

Brief summary:

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.

Conditions

Obesity

Smoking Cessation

Physical Inactivity

Study ID

NCT05687604

Start date

Sep 24, 2024

Status verified date

May, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

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.

Primary outcome measure

  • Effectiveness [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Rana Mazzetta, LMSW

312-503-6595rana.khalifeh@northwestern.edu

Laura Scanlan

312-503-1395laura.scanlan@northwestern.edu

Locations

Northwestern University-Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Bonnie Sring, Ph.D.

312-908-2293bspring@northwestern.edu

Principal Investigator:

Bonnie Spring, PhD, ABPP

More Information

Sponsor

Northwestern University

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-08.