Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
NCT ID: NCT05687604
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2024-09-24
2027-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Brian Hitsman
Associate Professor of Preventive Medicine
Principal Investigators
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Brian Hitsman, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Sofia Garcia, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Siobhan Phillips, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Bonnie Spring, PhD
Role: PRINCIPAL_INVESTIGATOR
Florida State University
Locations
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Northwestern University-Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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