Digital Health App for Lung Cancer

(THRIVE Trial)

Recruiting at 2 trial locations

Overseen By Jennifer Temel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychiatric disorder, Dementia, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital health app called THRIVE to determine if it can improve quality of life and alleviate symptoms for people with advanced lung cancer. Participants will either use the THRIVE app or receive their usual cancer care. The trial focuses on how well participants cope, manage symptoms, and perceive their health. It suits those diagnosed with advanced non-small cell lung cancer or extensive stage small cell lung cancer within the past 12 weeks who are comfortable using technology in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future patients' quality of life.

Will I have to stop taking my current medications?

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

What prior data suggests that the THRIVE digital health app is safe for patients with advanced lung cancer?

Research has shown that the THRIVE digital health app was tested in patients with advanced non-small cell lung cancer (NSCLC). Although detailed safety information is not provided, earlier studies found the app practical and generally well-received by patients.

As a digital app, THRIVE is less likely to cause physical side effects compared to medications. It aims to improve quality of life and help manage symptoms through supportive care. Available research has reported no major negative effects. Previous studies suggest the app is safe for use alongside regular cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the THRIVE Digital Health App because it offers a novel way to support lung cancer patients beyond traditional treatment methods like chemotherapy, radiation, and targeted therapies. Unlike the standard options, which primarily focus on directly attacking cancer cells, THRIVE uses a digital platform to empower patients with personalized health management tools. This app could enhance patients' quality of life by providing educational resources, tracking symptoms, and facilitating communication with healthcare providers, potentially leading to more tailored and responsive care.

What evidence suggests that the THRIVE digital health app is effective for improving quality of life in advanced lung cancer patients?

Research shows that the THRIVE digital health app, available to participants in this trial, might help people with advanced lung cancer feel better. Studies have found that the app helps users manage physical and emotional symptoms, aids in coping with their condition, and boosts confidence in handling health issues. Early results suggest that using THRIVE can noticeably improve overall well-being. While more research continues, these initial findings offer encouragement for those seeking extra support during treatment. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced non-small cell lung cancer (NSCLC) or extensive stage small cell lung cancer (SCLC), diagnosed within the last 12 weeks. Participants should be able to perform daily activities, at least half of their waking hours and must understand English well enough to use the THRIVE app.

Inclusion Criteria

I can understand and use English well enough for THRIVE.

I was diagnosed with advanced lung cancer or extensive small cell lung cancer in the last 3 months.

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

Exclusion Criteria

Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the 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 use the THRIVE digital health app or receive usual care for approximately 10 weeks

10 weeks

Tutorial sessions may be conducted in person, via telephone, or via Zoom

Follow-up

Participants are monitored for quality of life, physical symptoms, anxiety, and depression symptoms

24 weeks

Patient-reported outcome measures at 6, 12, and 24 weeks post-enrollment

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE

Trial Overview The study tests if a digital health application called THRIVE can improve quality of life, manage symptoms, aid coping, and boost self-efficacy in patients with advanced lung cancer compared to usual care. It's a multi-site randomized trial involving 250 participants.

How Is the Trial Designed?

Group I: Usual Care Active Control 1 Intervention

Patients assigned to the usual care group will not receive the digital app but rather standard oncology care.

Group II: THRIVE Digital Health App Active Control 1 Intervention

Patients assigned to the intervention will be provided a study-issued tablet computer from which they will access the THRIVE digital health app. Study staff will give intervention patients a comprehensive tutorial and detailed instructions regarding how to use the app. Tutorial sessions may be conducted in person during a clinic appointment, via telephone, and/or via Zoom videoconferencing. Participants will complete the intervention modules at their desired pace over approximately 10 weeks.

THRIVE is already approved in European Union, United States, Canada, Switzerland for the following indications:

Approved in European Union as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Approved in Canada as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in Switzerland as Lynparza for:

• Ovarian cancer
• Breast cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The combination of osimertinib and platinum-based chemotherapy (OPP) demonstrated a high objective response rate of 90.9% in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer, indicating strong efficacy.

The treatment was well-tolerated, with no treatment-related deaths and an acceptable safety profile, as only 14.9% of patients discontinued due to adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 study of osimertinib in combination with platinum and pemetrexed in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer: The OPAL Study. Saito, R., Sugawara, S., Ko, R., et al.[2023]

The ORIGAMA study is investigating the clinical utility of digital patient monitoring (DPM) tools, specifically the Roche DPM Module, in improving health outcomes and resource usage for cancer patients receiving systemic treatments, involving two cohorts with various cancer types.

Cohort A will assess the impact of DPM on symptom interference in patients with metastatic non-small cell lung cancer and other conditions, while Cohort B will evaluate the feasibility of administering atezolizumab at home, aiming to enhance flexible care and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the impact of digital patient monitoring on health outcomes and healthcare resource usage in addition to the feasibility of its combination with at-home treatment, in participants receiving systemic anticancer treatment in clinical practice: protocol for an interventional, open-label, multicountry platform study (ORIGAMA). Iivanainen, S., Baird, AM., Balas, B., et al.[2023]

In the FLAURA China study involving 136 patients with EGFR mutation-positive advanced non-small-cell lung cancer, first-line treatment with osimertinib significantly improved progression-free survival (PFS) by 8 months compared to comparator EGFR TKIs, with median PFS of 17.8 months versus 9.8 months.

Osimertinib also showed a trend towards improved overall survival (OS) with a median of 33.1 months compared to 25.7 months for the comparator group, while the safety profile was consistent with previous findings, with no new safety signals identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Cheng, Y., He, Y., Li, W., et al.[2022]

The FLAURA2 phase III trial demonstrated that combining chemotherapy with osimertinib significantly improves progression-free survival in patients with EGFR-mutant non-small cell lung cancer.

While the combination treatment is more effective, it also increases the likelihood of serious side effects, highlighting the importance of considering the risk-benefit ratio for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EGFR-Mutant NSCLC: Chemo-TKI Bests TKI. [2023]

In a phase 3 trial involving 682 patients with resected, EGFR-mutated, stage IB to IIIA non-small-cell lung cancer, adjuvant osimertinib therapy significantly improved overall survival, with a 5-year survival rate of 88% compared to 78% for placebo.

The treatment demonstrated a strong safety profile, with only one new serious adverse event reported that was not linked to the osimertinib regimen, confirming its tolerability in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. Tsuboi, M., Herbst, RS., John, T., et al.[2023]

A study involving 63 cancer outpatients treated with oral anticancer agents revealed that 74.6% reported at least one high-level symptom, highlighting the prevalence of adverse events in this population.

The most commonly reported symptoms included fatigue, psychological disorders, and general pain, indicating that patient-reported outcomes (PROs) are effective for identifying significant side effects and can be integrated into routine oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program. Collomb, B., Dubromel, A., Caffin, AG., et al.[2022]

The eOncosalud app was used by 186 cancer outpatients receiving oral antineoplastic agents, allowing for real-time monitoring and early detection of adverse effects (AEs), with a total of 1,368 AEs recorded, including fatigue and diarrhea as the most common.

The app's algorithm provided automatic recommendations for managing AEs, with a positive predictive value of 51% for emergency room visits, demonstrating its effectiveness in optimizing healthcare resources and improving patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital. Villanueva-Bueno, C., Collado-Borrell, R., Escudero-Vilaplana, V., et al.[2023]

In a study involving 23 patients with advanced non-small-cell lung cancer, common side effects of osimertinib treatment included coughing, itching, and tiredness, with shortness of breath and diarrhea becoming more prevalent after 4 months.

Despite experiencing side effects, patients reported high satisfaction with osimertinib and found it relatively easy to cope with these side effects, suggesting that the benefits of the treatment may outweigh the challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy. Rydén, A., Blackhall, F., Kim, HR., et al.[2022]

Osimertinib significantly improves progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation, showing a median PFS of 10.1 months compared to 4.4 months with chemotherapy in a trial of 419 patients.

The safety profile of osimertinib is favorable compared to other EGFR tyrosine kinase inhibitors and chemotherapy, with common side effects including diarrhea and rash, making it a viable treatment option for patients who have progressed on previous therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation. Odogwu, L., Mathieu, L., Goldberg, KB., et al.[2022]

The self-assessment smartphone app alerted 72.6% of users about concerning symptoms related to tobacco-induced diseases, with current smokers showing a higher incidence of symptoms like fatigue and cough, indicating a significant awareness of health issues.

During the study, the incidence of early-stage lung cancer (stages 1 and 2) increased to 24% among users, compared to 9% in the previous year, suggesting that the app may enhance early detection of lung cancer and encourage smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. Stavaux, E., Goupil, F., Barreau, G., et al.[2023]

The SeamlessMD App significantly improved patient engagement and satisfaction during the perioperative period for 50 patients undergoing robotic lung cancer surgery, with over 74% finding it very or extremely useful.

Patients using the App reported a significant decrease in maximum pain levels and anxiety scores post-surgery, and 40.9% indicated that the health-checks helped them avoid unnecessary calls or hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes. Kneuertz, PJ., Jagadesh, N., Perkins, A., et al.[2022]

A case report involving 6 patients with advanced PD-L1-positive cancers showed that using the Consilium app for monitoring symptoms during immunotherapy was effective, with patients reporting an average of 2.4 symptoms daily over 3 months.

The app facilitated high-quality shared reporting between patients and physicians, leading to timely alerts for severe symptoms without any safety issues or unplanned visits, indicating its potential to enhance clinical care in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment. Trojan, A., Huber, U., Brauchbar, M., et al.[2020]

The use of the e-OncoSalud mobile app for monitoring patients undergoing treatment with oral antineoplastic agents (OAAs) significantly improved treatment adherence, with 97.6% adherence in the app group compared to 92.9% in the control group (P=.02).

Patients using the app reported a higher health-related quality of life (mean index of 0.875) compared to the control group (0.741), and experienced fewer side effects, indicating that the app not only enhances patient autonomy but also optimizes health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study. Collado-Borrell, R., Escudero-Vilaplana, V., Ribed, A., et al.[2021]

In a 5-year follow-up of the KEYNOTE-024 trial involving 305 patients with untreated non-small-cell lung cancer (NSCLC), pembrolizumab significantly improved overall survival (OS) compared to platinum-based chemotherapy, with median OS of 26.3 months versus 13.4 months.

Patients receiving pembrolizumab showed a 5-year OS rate of 31.9%, and those who completed 35 cycles of treatment had an 82.1% survival rate, indicating that long-term treatment did not increase toxicity and provided durable benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50. Reck, M., Rodríguez-Abreu, D., Robinson, AG., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06427954

Mobile Application to Improve Health-Related Outcomes in ... Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40468832/

Pilot Feasibility Trial of a Supportive Care Digital ... Conclusions: Although the enrollment rate was lower than anticipated, patients with advanced NSCLC who received THRIVE met the feasibility ...

3. uclahealth.org uclahealth.org/clinical-trials/mobile-application-improve-health-related-outcomes-patients

Lung Cancer UCLA Clinical Trial | Mobile Application to ... Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical ...

4. withpower.com withpower.com/trial/phase-lung-neoplasms-8-2024-43745

Digital Health App for Lung Cancer (THRIVE Trial) Trial Overview The study tests if a digital health application called THRIVE can improve quality of life, manage symptoms, aid coping, and boost self-efficacy ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10325829/

Study protocol for a randomized trial of a supportive care ... A supportive care mobile application (app) for improving symptom management and adaptive coping in patients with advanced NSCLC.

6. researchgate.net researchgate.net/publication/392436335_Pilot_Feasibility_Trial_of_a_Supportive_Care_Digital_Application_for_Patients_with_Advanced_Nonsmall_Cell_Lung_Cancer

Pilot Feasibility Trial of a Supportive Care Digital ... Conclusions: Although the enrollment rate was lower than anticipated, patients with advanced NSCLC who received THRIVE met the feasibility criterion for app ...

7. ancora.ai ancora.ai/fr/details/NCT06427954

THRIVE: Mobile Application to Improve Health-Related ... THRIVE: Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer. Interventional. Phase not listed. Mass General Hospital.

8. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT06427954

University of California Health Lung Cancer Trial Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical and ...