Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors (NCT05687604) | Clinical Trial Compass
RecruitingNot Applicable
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
United States1,500 participantsStarted 2024-09-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.