NCT05687604

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of this clinical trial is to decrease adverse outcomes and improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients. 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

• Obesity
• Smoking Cessation
• Physical Inactivity

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2024-09-24
• Primary completion: 2027-04-30
• Completion: 2027-07-31
• First posted: 2023-01-18
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States