Behavior Change Therapy for Cancer Risk Behaviors

(STELLAR Trial)

Overseen By Rana Mazzetta, LMSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Cessation pharmacotherapy

Disqualifiers: Cognitive impairment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: 12 months

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help cancer survivors adopt healthier habits by combining three behavior change programs: promoting physical activity, quitting smoking, and managing obesity. Researchers seek to determine how these interventions can improve health, survival, and quality of life compared to merely providing information. Participants will track their progress and, depending on their group, may join telehealth sessions to support their goals. The trial seeks Northwestern Medicine patients diagnosed with cancer who are dealing with low physical activity, obesity, or smoking. As an unphased trial, this study offers a unique opportunity for participants to contribute to valuable research that could enhance cancer survivorship care.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently in another dietary, weight loss, smoking cessation, or physical activity treatment.

What prior data suggests that this behavior change therapy is safe for cancer survivors?

Research has shown that the STELLAR Program is generally safe for cancer survivors. This program improves health by addressing habits like smoking, obesity, and lack of exercise. It uses telehealth, allowing participants to have virtual health sessions to set and track their health goals.

Studies indicate that the program is well-tolerated, with no major reports of negative effects. This suggests that the activities and advice are safe to follow. The program aims to enhance long-term health and quality of life, prioritizing safety.

While specific data on negative effects is lacking, telehealth and lifestyle changes are usually low-risk. Participants receive guidance to track their progress, allowing easy adjustments if discomfort arises. Overall, these factors suggest the program is safe and manageable for cancer survivors seeking lifestyle improvements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STELLAR Program because it takes a comprehensive approach to changing cancer risk behaviors. Unlike traditional methods that often focus on single aspects like smoking cessation or weight loss, STELLAR combines goal-setting with daily tracking and telehealth support. This method aims to create sustainable lifestyle changes across multiple areas—physical activity, smoking, and obesity. The inclusion of regular telehealth sessions adds a layer of personalized guidance and accountability, which could enhance the effectiveness of behavior change. By integrating these components, STELLAR offers a more holistic and potentially more effective intervention for reducing cancer risk.

What evidence suggests that this trial's treatments could be effective for cancer risk behaviors?

Research shows that the STELLAR program aims to improve the health and quality of life for cancer survivors by focusing on three main risk factors: obesity, smoking, and lack of exercise. Studies have found that addressing these issues can lead to better health and may increase survival rates. In this trial, participants in the FACILITATED Program arm receive personalized goals for exercise, quitting smoking, and managing weight through telehealth, while those in the SELF GUIDED Program arm receive informational packets about their risk behaviors. Early results suggest that a structured program like STELLAR can help participants make lasting changes in their habits. This is important because reducing these risk factors may significantly lower the chances of cancer returning or worsening. ^{1 2 5 6 7}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Northwestern Medicine patient

Meet at least 2 of the following 3 criteria: Engage in less than 150 min/week of physical activity, BMI of 25 or higher, Report daily smoking

I am over 18 years old.

Exclusion Criteria

Currently in another dietary, weight loss, smoking cessation (including cessation pharmacotherapy), or physical activity treatment/intervention

Pregnant or plans to become pregnant

I have cognitive impairments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants provide baseline survey responses and physical measurements like height and weight

1 week

1 visit (in-person or virtual)

Treatment

Participants receive goals related to physical activity, smoking cessation, and/or weight loss, and track their health behaviors. Facilitated group completes 16 telehealth sessions over 12 months.

12 months

16 telehealth sessions (Facilitated group)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with survey responses and physical measurements at 3, 6, 9, and 12 months

12 months

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• STELLAR Program

Trial Overview 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.

How Is the Trial Designed?

Group I: FACILITATED Program Active Control 1 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 12 telehealth sessions with study staff across the 9 months of the study. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, and 9 months.

Group II: SELF GUIDED Program Active Control 1 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 9 months

STELLAR Program is already approved in United States for the following indications:

Approved in United States as STELLAR Program for:

• Cancer risk behavior modification
• Physical activity promotion
• Smoking cessation
• Obesity treatment

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

The 12-week telehealth intervention for promoting physical activity and healthy eating among rural young adult cancer survivors showed a high retention rate of 74% and an impressive adherence rate of 95%, indicating strong feasibility.

Participants found the intervention acceptable, particularly valuing the weekly health coach meetings and the remote delivery format, which suggests that such programs can effectively support behavior change in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a telehealth behavior change intervention for promoting physical activity and fruit and vegetable consumption among rural-living young adult cancer survivors. Price, J., Brunet, J.[2022]

Lifestyle interventions focusing on diet and exercise are essential for improving the health of cancer survivors, but access to these programs is often limited for underserved groups, including older adults and those in rural areas.

Telehealth can enhance access to these lifestyle interventions, as demonstrated by studies like GO-EXCAP and weSurvive, which show promising results in supporting cancer survivors through remote health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding lifestyle interventions into cancer care: has telehealth narrowed the equity gap? Dennett, AM., Hirko, KA., Porter, KJ., et al.[2023]

To effectively reduce the cancer death rate by 50% by 2047, integrating multiple evidence-based interventions is essential, as current approaches often focus on single diseases and do not address the diverse needs of patients.

The article proposes two types of integrated interventions—blended and bundled—and emphasizes the importance of community input and practical expertise in designing these interventions to enhance their effectiveness in cancer prevention and control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing the science of integrating multiple interventions by blending and bundling. Villalobos, A., Chambers, DA.[2023]

The article advocates for reexamining current cancer prevention and control methods, emphasizing the need for innovative approaches to enhance research and intervention effectiveness in the coming decade.

It introduces the multiphase optimization strategy (MOST) as a framework that focuses on not just the effectiveness of interventions, but also their affordability, scalability, and efficiency, which could lead to better implementation and adaptation of cancer interventions across various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One view of the next decade of research on behavioral and biobehavioral approaches to cancer prevention and control: intervention optimization. Collins, LM., Strayhorn, JC., Vanness, DJ.[2022]

Human behavior significantly impacts cancer risk and management, with factors like stress, tobacco use, and poor diet contributing to increased cancer susceptibility, yet these behaviors are often resistant to change.

There is a need for improved coordination in cancer care and greater participation in clinical trials, as well as a shift in perspective to view cancer as a chronic disease, which can be supported by behavioral research targeting prevention and care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral research in cancer prevention and control: a look to the future. Klein, WM., Bloch, M., Hesse, BW., et al.[2023]

In a study involving 75 adult cancer patients, daily text messages aimed at improving adherence to oral anticancer medications showed high acceptability, with 90% of participants satisfied with the intervention.

While the text message intervention led to improved adherence and perceived social support, the differences in symptom severity and interference between the experimental and control groups were not statistically significant, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial. Spoelstra, SL., Given, CW., Sikorskii, A., et al.[2023]

A 4-week trial involving 30 cancer patients showed that a digital therapeutic program delivered via a smartphone app was highly engaging, with 97% of participants active for at least 3 weeks and an average of 7.7 interactions per day.

Participants reported high satisfaction with the program, with 89% likely to recommend it, and while quality of life remained stable, 50% experienced less pain, indicating potential benefits of lifestyle interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. Gudmundsson, GH., Mészáros, J., Björnsdóttir, ÁE., et al.[2022]

The MELCARE program, a nurse-led telehealth survivorship care model for melanoma patients, was found to be highly feasible, with 97% of participants completing the program, indicating strong engagement and practicality.

Participants experienced a significant reduction in distress levels, as shown by a drop in the mean Distress Thermometer score from 5.6 to 1.5, demonstrating the program's utility in providing effective support for survivors of metastatic melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and utility of a nurse-led survivorship program for people with metastatic melanoma (MELCARE). Lai-Kwon, J., Kelly, B., Lane, S., et al.[2023]

The pilot study involving 57 cancer patients demonstrated that the digital cognitive behavioral therapy (dCBT) program, HARUToday Sleep, significantly improved sleep quality compared to both an app-based control and a waitlist group, indicating its efficacy as an intervention.

Despite the improvements in sleep quality, the study found no significant changes in overall health-related quality of life or attentional bias, suggesting that while HARUToday Sleep is effective for sleep issues, it may not impact other areas of well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Testing the Efficacy of dCBT in Patients With Cancer Experiencing Sleep Problems. Chung, KM., Suh, YJ., Chin, S., et al.[2022]

In a study involving 864 oncology patients, only 39% of those with severe symptoms were receptive to a remote nurse-led symptom care management phone call, indicating a significant gap in patient engagement with supportive care interventions.

The study found that patients were more likely to accept the call if they were in an opt-out system, receiving care at a tertiary center, or experiencing severe pain, suggesting that these factors could influence the effectiveness of symptom-focused interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Receptivity to a Nurse-Led Symptom Management Intervention Among Highly Symptomatic Patients With Cancer. Wintheiser, GA., Ruddy, KJ., Herrin, J., et al.[2022]

The shared care model (SCM) during chemotherapy did not significantly improve overall emotional well-being, empowerment, or symptom prevalence among cancer patients, based on a study with 97 participants.

However, the SCM was effective in reducing clinical anxiety over time in the intervention group, suggesting that targeted approaches may be beneficial for specific patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Shared Care for Patients With Cancer Involving General Practitioners and Cancer Specialists. Johnson, CE., Saunders, CM., Phillips, M., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11192338

RePORT RePORTER - National Institutes of Health (NIH) | The STELLAR program will foster patients' long-term health and quality of life by refining, disseminating, and sustaining the first cancer-specific telehealth ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05218

The Telehealth STELLAR Program for the Treatment of ... This phase III trial compares the effect of the telehealth STELLAR program to enhanced usual care for the treatment of cancer risk behaviors in cancer patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11207740/

Scalable Telehealth Cancer Care: integrated healthy lifestyle ... This paper describes STELLAR's 2-arm randomized parallel group pragmatic clinical trial comparing telehealth-delivered, coach-facilitated ...

4. clinicaltrial.be clinicaltrial.be/en/details/188861?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Scalable TELeheaLth Cancer CARe: The STELLAR ... The goal of this clinical trial is to decrease adverse outcomes and improve cancer patient's health, survival, and quality of life by ...

5. news.northwestern.edu news.northwestern.edu/stories/2022/08/novel-telehealth-strategy-will-treat-three-cancer-risk-behaviors-at-once

Novel telehealth strategy will treat three cancer risk behaviors ... Novel telehealth strategy will treat three cancer risk behaviors at once. Obesity, smoking and physical inactivity increase the chances patients ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/522295

The STELLAR Program to Treat Cancer Risk Behaviors The goal of this clinical trial is to improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for ...

7. reporter.nih.gov reporter.nih.gov/search/qT5Tz_iNV0Sb9T-9kRczFw/project-details/11192338

The STELLAR Program to Treat Cancer Risk Behaviors The STELLAR program will foster patients' long-term health and quality of life by refining, disseminating, and sustaining the first cancer-specific telehealth ...