Clinical trial NCT05687604: Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Official title: Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Smoking Cessation
Physical Inactivity
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized control trial with 2 parallel intervention arms. One arm will be the active treatment group, and the other an enhanced usual-care control group. Assessors will be blinded to study condition, and intervention will be behavioral.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Reach/Access
timeFrame: Baseline
Secondary outcomes:
measure: Smoking
timeFrame: baseline, 3, 6 and 9 months
measure: Body Weight
timeFrame: baseline, 3, 6 and 9 months
measure: Self-Reported Weekly Amount (in days and minutes) of Moderate Intensity Physical Activity
timeFrame: baseline, 3, 6 and 9 months
measure: Godin Leisure Time Exercise Questionnaire
timeFrame: baseline, 3, 6 and 9 months
measure: Total Healthcare Cost and Amount of Patient Care Utilization
timeFrame: baseline, 3, 6 and 9 months
measure: Rating of Care Quality as Measured by the Consumer Assessment of Healthcare Providers & Systems Cancer Care Survey)
timeFrame: baseline, 3, 6 and 9 months
measure: Rating of Patient-Provider Communication and Shared Decision-Making as Measured by The Interpersonal Process of Care (IPC32)
timeFrame: baseline, 3, 6 and 9 months
measure: Rating of Symptoms and Functioning as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile
timeFrame: baseline, 3, 6 and 9 months
measure: Rating of Quality of Life Using the Health Related Quality of Life Short Form (HRQOL SF-12)
timeFrame: baseline, 3, 6 and 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University-Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Brian Hitsman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Sofia Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Siobhan Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spring B, Garcia SF, Daly E, Jacobs M, Jayeoba M, Jordan N, Kircher S, Kocherginsky M, Mazzetta R, Pollack T, Scanlan L, Scherr C, Hitsman B, Phillips SM. Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):83-91. doi: 10.1093/jncimonographs/lgae020.
citation: Rendle KA, Tan ASL, Spring B, Bange EM, Lipitz-Snyderman A, Morris MJ, Makarov DV, Daly R, Garcia SF, Hitsman B, Ogedegbe O, Phillips S, Sherman SE, Stetson PD, Vachani A, Wainwright JV, Zullig LL, Bekelman JE. A Framework for Integrating Telehealth Equitably across the cancer care continuum. J Natl Cancer Inst Monogr. 2024 Jun 26;2024(64):92-99. doi: 10.1093/jncimonographs/lgae021.