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

Trial Summary

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 data supports the effectiveness of the digital health app for lung cancer treatment?

Research shows that using a mobile app for self-assessment can help detect lung cancer relapses early, which may lead to longer survival. Additionally, digital patient monitoring tools have been found to improve patient outcomes and clinical care in cancer treatment. ^{1 2 3 4 5}

Is the digital health app for lung cancer treatment safe for humans?

The digital health app for monitoring cancer treatment has been used safely in patients, with no unplanned visits or safety issues reported. Patients using similar apps for cancer treatment have reported symptoms like fatigue and appetite loss, but overall satisfaction with the app's usability and safety was high. ^{5 6 7 8 9}

How is the drug THRIVE (Lynparza, Olaparib) unique for lung cancer treatment?

THRIVE (Lynparza, Olaparib) is unique because it is a PARP inhibitor, which works by preventing cancer cells from repairing their DNA, leading to cell death. This mechanism is different from traditional chemotherapy or targeted therapies like osimertinib, which focus on specific mutations in cancer cells. ^{10 11 12 13 14}

What is the purpose of this 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 psychological symptoms, coping, and self-efficacy in 250 patients with newly diagnosed advanced lung cancer.

Eligibility Criteria

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 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.

I can understand and use English well enough for THRIVE.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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 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]

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]

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]

References

1. Canada 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. [2021]

2. Canada 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. [2023]

3. China 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. [2022]

4. England 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). [2023]

5. Switzerland 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program. [2022]

7. Switzerland 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. [2023]

8. New Zealand 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. [2022]

9. England 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. [2022]

10. England 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. [2023]

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

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

12. United States 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. [2022]

13. France pubmed.ncbi.nlm.nih.gov

Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. [2022]

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

Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. [2023]