Behavior Change Therapy for Cancer Risk Behaviors

(STELLAR Trial)

Overseen by Bonnie Spring, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Must not be taking: Cessation pharmacotherapy

Disqualifiers: Cognitive impairment, Pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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 Facilitated group will complete 16 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.

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 data supports the effectiveness of the STELLAR Program treatment for cancer risk behaviors?

Research shows that digital therapeutic programs can help cancer patients improve their symptoms and quality of life by supporting lifestyle changes and remote symptom monitoring. Additionally, telehealth interventions have been found feasible and acceptable for promoting healthy behaviors like physical activity and diet among cancer survivors. ^{1 2 3 4 5}

Is the Behavior Change Therapy for Cancer Risk Behaviors safe for humans?

The studies reviewed did not report any safety concerns related to the telehealth behavior change interventions, suggesting they are generally safe for human use. ^{1 5 6 7 8}

How is the STELLAR Program treatment different from other treatments for cancer risk behaviors?

The STELLAR Program is unique because it uses telehealth to deliver behavior change therapy, making it more accessible for people who may not have easy access to in-person care. This approach focuses on modifying lifestyle behaviors, such as diet and physical activity, which are crucial for cancer prevention and management. ^{1 5 9 10 11}

Research Team

Brian Hitsman, PhD

Principal Investigator

Northwestern University

Siobhan Phillips, PhD

Principal Investigator

Northwestern University

Sofia Garcia, PhD

Principal Investigator

Northwestern University

Bonnie Spring, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Northwestern Medicine patient

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

My English or Spanish skills are limited.

Trial Timeline

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)

Treatment Details

Interventions

• STELLAR Program (Behavioral Intervention)

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.

Participant Groups

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 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: 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 12 months

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Receptivity to a Nurse-Led Symptom Management Intervention Among Highly Symptomatic Patients With Cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and utility of a nurse-led survivorship program for people with metastatic melanoma (MELCARE). [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Shared Care for Patients With Cancer Involving General Practitioners and Cancer Specialists. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Embedding lifestyle interventions into cancer care: has telehealth narrowed the equity gap? [2023]

7. United States 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. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study Testing the Efficacy of dCBT in Patients With Cancer Experiencing Sleep Problems. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Advancing the science of integrating multiple interventions by blending and bundling. [2023]

10. England 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. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral research in cancer prevention and control: a look to the future. [2023]