NCT05687604 Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
| NCT ID | NCT05687604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2024-09-24 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Brian Hitsman, PhD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT05687604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05687604 currently recruiting?
Yes, NCT05687604 is actively recruiting participants. Contact the research team at rana.khalifeh@northwestern.edu for enrollment information.
Where is the NCT05687604 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05687604 clinical trial?
NCT05687604 is sponsored by Northwestern University. The principal investigator is Brian Hitsman, PhD at Northwestern University. The trial plans to enroll 1,500 participants.
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