RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-24
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05687604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Northwestern Medicine patient
  2. * Over 18 years old
  3. * Meet at least 1 of the following 3 criteria:
  4. * Engage in \<150 min/week of physical activity
  5. * BMI of ≥25
  6. * Report that they currently smoke or smoked within the last year
  7. * Diagnosed with any cancer (except non-melanoma skin)
  8. * Ability to attend telehealth visits either via landline, cell phone, smartphone, tablet, laptop, or desktop computer
  9. * 3 months post curative intent treatment if BMI of ≥25 or engage in \<150 min/week of physical activity
  10. * Post curative intent treatment if they currently smoke or smoked within the last year
  1. * Currently in another dietary, weight loss, smoking cessation (including cessation pharmacotherapy), or physical activity treatment/intervention.
  2. * Limited level of oral and written English or Spanish
  3. * Cognitively impaired adults
  4. * Prisoners
  5. * Participants will be excluded from the physical activity and weight loss interventions (but not the smoking cessation component) for:
  6. * 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
  7. * Pregnant or plans to become pregnant.
  8. * Individuals engaging in the physical activity or weight loss interventions must pass pre- physical activity participation screening or obtain medical clearance

Contacts and Locations

Study Contact

Rana Mazzetta, LMSW
CONTACT
312-503-6595
rana.khalifeh@northwestern.edu
Laura Scanlan
CONTACT
312-503-1395
laura.scanlan@northwestern.edu

Principal Investigator

Brian Hitsman, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University
Sofia Garcia, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University
Siobhan Phillips, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University
Bonnie Spring, PhD
PRINCIPAL_INVESTIGATOR
Florida State University

Study Locations (Sites)

Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Brian Hitsman, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Sofia Garcia, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Siobhan Phillips, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Bonnie Spring, PhD, PRINCIPAL_INVESTIGATOR, Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-24
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-09-24
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Smoking Cessation
  • Physical Inactivity