Digital Health App for Lung Cancer Survivors

Overseen By Joseph A. Greer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Uncontrolled psychiatric disorder, dementia, others

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

Compensation: Varies

Number of Visits: 30

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital health app designed to help lung cancer survivors improve their overall wellbeing. The app, called PROMOTE, assists users in managing physical health, breathing difficulties, sleep problems, and diet. It aims to demonstrate that people using the app experience better physical function and quality of life compared to those receiving standard care. The trial seeks lung cancer survivors who began treatment within the last six weeks and are receiving care at participating institutions. Participants will either use the PROMOTE app or receive standard care with additional educational materials, and researchers will monitor their progress over time. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance the quality of life for lung cancer survivors.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the PROMOTE digital health app is safe for lung cancer survivors?

In a previous study, researchers found that digital health apps can help lung cancer patients enhance their physical abilities and overall well-being. This finding is encouraging for those considering the PROMOTE app, as it suggests the app might have positive effects. Another review showed that technology-based tools for cancer patients are generally well-received and can support them during treatment.

The PROMOTE app addresses issues like shortness of breath, sleep problems, and staying active. While specific data on side effects from the app itself is not available, digital health tools like PROMOTE usually don't carry the same risks as medication. Generally, users of such apps report few, if any, negative effects, indicating they are likely safe to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PROMOTE Digital Health App Intervention because it offers a holistic and personalized approach to improving the quality of life for lung cancer survivors. Unlike traditional care, which primarily focuses on medical treatments and managing side effects, this app provides interactive modules that address a wide range of survivor needs, from energy management and physical activity to sleep enhancement and mood regulation. By integrating cognitive-behavioral strategies and evidence-based breathing techniques, the app empowers users to take an active role in their recovery and long-term wellness. Additionally, the flexibility to complete modules at their own pace over ten weeks offers a tailored experience that aligns with each patient’s unique journey.

What evidence suggests that the PROMOTE app is effective for lung cancer survivors?

Research has shown that digital health tools can greatly improve the lives of people with lung cancer. A review of studies found that these tools help manage symptoms like difficulty breathing, trouble sleeping, and mood changes. Other studies have demonstrated that similar programs can increase activity levels and enhance overall well-being. For instance, a digital health program for cancer patients led to better self-care and improved mood. Lung cancer patients believe that staying active can reduce tiredness and improve sleep. In this trial, participants using the PROMOTE Digital Health App Intervention may experience similar benefits, as the app is designed to help lung cancer survivors take better care of their health. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for lung cancer survivors treated for cure, specifically stages I-III. Participants should be interested in improving their physical function and wellness through a digital health app intervention. They will be enrolled at an academic cancer center or affiliated community sites.

Inclusion Criteria

Primary cancer care at one of the participating institutions

I started treatment including chemotherapy for my cancer less than 6 weeks ago.

I can take care of myself and am up more than half the day.

Exclusion Criteria

Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's ability to participate in study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PROMOTE app intervention or enhanced usual care for 12 weeks

12 weeks

Surveys at enrollment, 6, 12, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Surveys at 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PROMOTE Digital Health App Intervention

Trial Overview The study tests the 'PROMOTE' mobile app designed to help lung cancer survivors with physical activity, nutrition, breathlessness, insomnia, and overall wellbeing against enhanced usual care with health education materials. It's a randomized trial where participants are assigned to one of these two groups.

How Is the Trial Designed?

Group I: PROMOTE Digital Health App Intervention Experimental Treatment 1 Intervention

Patients will receive a study-issued tablet computer with the PROMOTE app that includes the following modules: 1) introductory education regarding the diagnosis and treatment trajectory of lung cancer; 2) behavioral interventions for improving physical function by managing fluctuations in energy and fostering engagement in valued life activities; 3) evidence-based breathing techniques for coping with dyspnea and improving lung function; 4) cognitive-behavioral strategies for enhancing sleep quality and efficiency; 5) approaches for increasing physical activity through adaptation and graded exercises; 6) tips for healthy eating and managing digestive side effects of cancer treatment, and 7) skills for managing mood symptoms through effective problem-, emotion-, and acceptance-based coping strategies. Patients will complete the intervention modules at their desired pace over approximately 10 weeks, in addition to their standard oncology care.

Group II: Enhanced Usual Care Active Control 1 Intervention

Patients will receive standard oncology care plus health educational materials about treatments for lung cancer, side effect management, and survivorship from the American Cancer Society (either in electronic or hardcopy formats).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07227623?cond=Lung+Diseases

Randomized Trial of a Digital Health Intervention to ... The rationale for the proposed project is to improve the experience and outcomes of individuals diagnosed with lung cancer treated for cure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9862347/

Digital Health Interventions for Adult Patients With Cancer ... This scoping review summarized digital health interventions developed and evaluated in RCTs involving adult patients with cancer.

3. nature.com nature.com/articles/s41746-025-01913-7

Systematic review on the technology's role in supporting ... This systematic review examines the role of technology-based interventions in supporting lung cancer patients during their treatment.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2347562525001076

Insights from advanced lung cancer patients in Hong Kong Most believed PA could alleviate fatigue (72.0%), improve mood (72.0%), enhance sleep (65.9%), and relieve cancer-related discomfort (53.7%). However, only 34.1 ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.1570

Digital health program for patients with cancer to support ... Sidekick Health's 13-week digital health program was built to support cancer self-management. It was available free of charge to US-based cancer patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12124549/

Patient engagement strategies in digital health interventions ... This scoping review aimed to explore the state of patient engagement in research on digital health platforms for cancer survivors, including ...

7. jmir.org jmir.org/2024/1/e53015/

Supportive eHealth Technologies and Their Effects on ... The findings indicate that eHealth technologies can positively impact physical functioning and well-being for people with lung cancer.