Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05687604

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Smoking Cessation, Physical Inactivity

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Northwestern University-Feinberg School of Medicine🇺🇸 Chicago, Illinois, United States

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Bonnie Sring, Ph.D.Contact

Email · Call 312-908-2293

Bonnie Spring, PhD, ABPPPrincipal Investigator