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Behavioral Intervention
Behavior Change Therapy for Cancer Risk Behaviors (STELLAR Trial)
N/A
Waitlist Available
Led By Sofia Garcia, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 9 and 12 months
Awards & highlights
STELLAR Trial Summary
This trial seeks to improve cancer survivors' health and quality of life by combining physical activity promotion, smoking cessation and obesity treatment into one intervention program. Participants will track their health behaviors and be assessed at baseline, 3, 6 and 12 months.
Who is the study for?
The STELLAR trial is for Northwestern Medicine cancer survivors over 18, who are not very active (less than 150 minutes of exercise per week), have a BMI of ≥25, or smoke daily. They must be able to attend telehealth visits and speak English or Spanish. People with severe health issues, those in other similar interventions, or pregnant women can't join.Check my eligibility
What is being tested?
STELLAR tests a combined intervention program against enhanced usual care to see if it better improves physical activity, smoking cessation, and obesity treatment among cancer survivors. It includes tracking health behaviors and attending telehealth sessions to discuss progress towards goals.See study design
What are the potential side effects?
Since this trial involves behavior change therapy through telehealth sessions rather than medication or medical procedures, there are no direct side effects like you'd expect from drugs; however participants may experience discomfort adjusting to new lifestyle changes.
STELLAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6, 9 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 9 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reach/Access
Secondary outcome measures
Body Weight
Godin Leisure Time Exercise Questionnaire
Rating of Care Quality as Measured by the Consumer Assessment of Healthcare Providers & Systems Cancer Care Survey)
+6 moreSTELLAR Trial Design
2Treatment groups
Active Control
Group I: STELLAR ProgramActive Control1 Intervention
STELLAR arm participants will receive 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.
Group II: Enhanced Usual CareActive Control1 Intervention
Patients in the EUC group will receive informational packets about their risk behaviors - obesity, physical inactivity, and/or smoking. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 12 months
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
914,231 Total Patients Enrolled
32 Trials studying Obesity
8,332 Patients Enrolled for Obesity
Sofia Garcia, PhDPrincipal InvestigatorNorthwestern University
Bonnie Spring, PhDPrincipal InvestigatorNorthwestern University
9 Previous Clinical Trials
2,536 Total Patients Enrolled
1 Trials studying Obesity
492 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My English or Spanish skills are limited.I am cleared by a doctor to start a new exercise or weight loss program.I have cognitive impairments.I am over 18 years old.I have had cancer before.I don't have severe heart issues, spreading cancer, or upcoming surgery.I can attend telehealth visits with a phone or computer.
Research Study Groups:
This trial has the following groups:- Group 1: STELLAR Program
- Group 2: Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for participants in this trial?
"Clinicaltrials.gov suggests that this particular medical trial is currently not actively recruiting participants, with the last date of updating being on January 6th 2023. Although it no longer requires new candidates, there are a plethora of other clinical trials still seeking volunteers in numerous fields of medicine."
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