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NCT05687604
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Conditions: Obesity, Smoking Cessation, Physical Inactivity
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 3000
Sponsor: Northwestern University
Location: United States
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 12 months into the study, participants will provide survey responses and physical measurements like height and weight.
Additionally, those in the STELLAR group will complete 16 telehealth sessions with study staff to discuss progress towards their study goals.Researchers will compare the STELLAR intervention group to the Enhanced Usual Care group to see if the STELLAR intervention group is able to reach more participants that Enhances Care only.
Eligibility Criteria
Inclusion Criteria:Northwestern Medicine patientOver 18 years oldMeet at least 2 of the following 3 criteria:Engage in <150 min/week of physical activityBMI of ≥25Report daily smoking.History of cancer (all tumor types)Ability to attend telehealth visits either via landline, cell phone, smartphone, tablet, laptop, or desktop computerExclusion 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 SpanishCognitively impaired adultsPrisoners.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 surgeryPregnant 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
Source: ClinicalTrials.gov (NCT05687604). StuddyBuddy aggregates publicly available trial information.