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

NCT05687604 | Recruiting DMC

• 1 other identifier: P50CA271353
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Reach

  Baseline

• Smoking

  baseline, 3, 6 and 9 months

• Body Weight

  baseline, 3, 6 and 9 months

• Self-Reported Weekly Amount (in days and minutes) of Moderate Intensity Physical Activity

  baseline, 3, 6 and 9 months

• Total Healthcare Cost and Amount of Patient Care Utilization

  baseline, 3, 6 and 9 months

Study Arms (2)

FACILITATED Program

ACTIVE COMPARATOR

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

SELF GUIDED Program

NO INTERVENTION

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 BEHAVIORAL

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.

FACILITATED Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 38924795 BACKGROUND

• 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.

  PMID: 38924790 BACKGROUND

MeSH Terms

Conditions

Obesity; Smoking Cessation; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Brian Hitsman, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Sofia Garcia, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Siobhan Phillips, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Bonnie Spring, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Mazzetta, LMSW

CONTACT

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

Laura Scanlan

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Preventive Medicine

Model Details: This is a randomized control trial with 2 parallel intervention arms. One arm will be the active treatment group, and the other an enhanced usual-care control group. Assessors will be blinded to study condition, and intervention will be behavioral.

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 18, 2023
• Study Start: September 24, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available within 1 year of completion of primary data collection
• Access Criteria: Please email the principle investigator for access

Locations

US (1)