Trial Title:
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
NCT ID:
NCT05687604
Condition:
Obesity
Smoking Cessation
Physical Inactivity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
multiple behavior change therapy
Description:
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.
Arm group label:
STELLAR Program
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 12 months into the study, participants will
provide survey responses and physical measurements like height and weight. Additionally,
those in the STELLAR group will complete 16 telehealth sessions with study staff to
discuss progress towards their study goals.
Researchers will compare the STELLAR intervention group to the Enhanced Usual Care group
to see if the STELLAR 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 STELLAR 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 STELLAR 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 12 months into
the study, participants will provide survey responses and physical measurements like
height and weight. Additionally, those in the STELLAR group will complete 16 telehealth
sessions with study staff to discuss progress towards their study goals.
Researchers will compare the STELLAR intervention group to the Enhanced Usual Care group
to see if the STELLAR intervention group is able to reach more participants that Enhances
Care only.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Northwestern Medicine patient
- Over 18 years old
- Meet at least 2 of the following 3 criteria:
- Engage in <150 min/week of physical activity
- BMI of ≥25
- Report daily smoking.
- History of cancer (all tumor types)
- Ability to attend telehealth visits either via landline, cell phone, smartphone,
tablet, laptop, or desktop computer
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University-Feinberg School of Medicine
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bonnie Sring, Ph.D.
Phone:
312-908-2293
Email:
bspring@northwestern.edu
Investigator:
Last name:
Bonnie Spring, PhD, ABPP
Email:
Principal Investigator
Start date:
August 30, 2024
Completion date:
July 2027
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687604
