Digital Health App for Lung Cancer
(THRIVE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Psychiatric disorder, Dementia, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
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.
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?
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.56789
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.1011121314
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 am 18 years old or older.
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.
See 1 more
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
Trial 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 (Behavioral Intervention)
Trial OverviewThe 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
2Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Patients assigned to the usual care group will not receive the digital app but rather standard oncology care.
Group II: THRIVE Digital Health AppActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Veteran Affairs Greater Los Angeles Health CareLos Angeles, CA
Massachusetts General HospitalBoston, MA
University of California Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
United States Department of DefenseCollaborator
References
Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study. [2021]Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care.
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]Patient self-assessment via a mobile app detects actionable symptoms and has been shown to detect lung cancer relapses early, thereby lengthening survival.
Improving patient engagement, adherence, and satisfaction in lung cancer surgery with implementation of a mobile device platform for patient reported outcomes. [2022]Active patient engagement may improve their perioperative experience and outcomes. We sought to evaluate the use of a mobile device application (App) for patient engagement and patient reported outcomes (PROs) assessment following robotic lung cancer surgery.
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]Digital patient monitoring (DPM) tools can enable more effective clinical care and improved patient outcomes in cancer. However, their broad adoption requires ease of use and demonstration of real-world clinical utility/impact. ORIGAMA (MO42720) is an interventional, open-label, multicountry platform study investigating the clinical utility of DPM tools and specific treatments. ORIGAMA will begin with two cohorts that aim to assess the impact of the atezolizumab-specific Roche DPM Module (hosted on the Kaiku Health DPM platform (Helsinki, Finland)) on health outcomes and healthcare resource usage, and its feasibility to support at-home treatment administration, in participants receiving systemic anticancer treatment. Other digital health solutions may be added to future cohorts.
Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment. [2020]Digital patient monitoring gains importance for quality of clinical cancer care. Our case report provides insight into usability and acceptance of a smartphone app for monitoring of electronically captured patient-reported outcomes in patients undergoing immunotherapy. During 3 months, 6 patients with advanced or metastatic PD-L1-positive cancer of the lung, prostate, and bladder who underwent checkpoint immunotherapy were using the Consilium app for standardized and structured electronic reporting of symptoms and therapy side effects. We evaluated the number and quality of symptom entries as well as usability and safety of shared reporting between the patient and the treating physician. Duration of anti-PD-L1-directed immunotherapy in the 6 patients ranged from 4 to 10 months and comprised a total of 21 anti-PD-L1-directed immunotherapy cycles. Patients reported between 4 and 16 different symptoms, of which the most frequent (57%) were dry cough, fatigue, shortness of breath, fever, and appetite loss. Overall, 1,279 symptom entries were counted, corresponding to 2.4 symptom entries per patient per day. Symptom severity grading ranged from 0.1 (very slight symptoms) to 7.8 (severe symptoms), which triggered prespecified alerts in 4 of the 6 patients. No unplanned visits were noted, and no safety issues occurred. Satisfaction with the app usability was high, as was the beneficial effect on consultation. Usability and reviewed data entries indicate high shared reporting efforts of patients and treating physicians and overall satisfaction with electronically reported patient outcomes.
Assessment of Patient Reported Outcomes (PROs) in Outpatients Taking Oral Anticancer Drugs Included in the Real-Life Oncoral Program. [2022]Background In previous studies, patient-reported outcomes (PROs) have been shown to improve survival in cancer patients. The aim of the present study was to assess symptoms potentially related to adverse events experienced by cancer outpatients treated by oral anticancer agents (OAAs) using PROs. Methods Between September 2018 and May 2019, outpatients starting OAAs were included in a 12-week follow-up to assess 15 symptoms listed in the National Cancer Institute PRO Common Terminology Criteria for Adverse Events, using a 5-point scale of severity or frequency. Patients were requested to alert a referral nurse or pharmacist when they self-assessed high-level (level 3 or 4) symptoms. Results 407 questionnaires were completed by 63 patients in which 2333 symptoms were reported. Almost three-quarters (74.6%) reported at least one high-level symptom. The symptoms that were most commonly experienced were fatigue (>9 in 10 patients; 13.2% of symptoms declared), various psychological disorders (>9 in 10 patients; 28.6% of symptoms declared) and general pain (>8 in 10 patients; 9.4% of symptoms declared). Conclusion PROs are appropriate to detect potential adverse events in cancer outpatients treated by OAAs. This study is the first step for integrating the patient's perspective in a digital e-health device in routine oncology care.
A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital. [2023]This study aims to analyze the impact of the eOncosalud app on the management and follow-up of adverse effects (AE) in patients receiving oral antineoplastic agents.
Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy. [2022]Capturing the patient experience during treatment is important to both regulatory authorities and to patients starting treatment. We identified the symptoms and side effects experienced by patients with advanced non-small-cell lung cancer during osimertinib treatment, to understand treatment expectations, satisfaction, and the level of difficulty coping with the side effects experienced during treatment.
FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation. [2022]On March 30, 2017, the U.S. Food and Drug Administration (FDA) approved osimertinib for the treatment of patients with metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive, non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed following EGFR tyrosine kinase inhibitor (TKI) therapy. Approval was based on demonstration of a statistically significant difference in the primary endpoint of progression-free survival (PFS) when comparing osimertinib with chemotherapy in an international, multicenter, open-label, randomized trial (AURA3). In this confirmatory trial, which enrolled 419 patients, the PFS hazard ratio for osimertinib compared with chemotherapy per investigator assessment was 0.30 (95% confidence interval 0.23-0.41), p < .001, with median PFS of 10.1 months in the osimertinib arm and 4.4 months in the chemotherapy arm. Supportive efficacy data included PFS per blinded independent review committee demonstrating similar PFS results and an improved confirmed objective response rate per investigator assessment of 65% and 29%, with estimated median durations of response of 11.0 months and 4.2 months, in the osimertinib and chemotherapy arms, respectively. Patients received osimertinib 80 mg once daily and had a median duration of exposure of 8 months. The toxicity profile of osimertinib compared favorably with the profile of other approved EGFR TKIs and chemotherapy. The most common adverse drug reactions (>20%) in patients treated with osimertinib were diarrhea, rash, dry skin, nail toxicity, and fatigue. Herein, we review the benefit-risk assessment of osimertinib that led to regular approval, for patients with metastatic NSCLC harboring EGFR TKI whose disease has progressed on or after EGFR TKI therapy.
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]This multicenter phase 2 trial evaluated the safety and efficacy of osimertinib and platinum-based chemotherapy (OPP) in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer (NSCLC).
EGFR-Mutant NSCLC: Chemo-TKI Bests TKI. [2023]Findings from FLAURA2, a phase III trial, show that adding chemotherapy to osimertinib, the preferred standard of care for patients with EGFR-mutant non-small cell lung cancer, significantly boosts progression-free survival. Serious side effects are also more likely with the combination, though, so patients should weigh the risk-benefit ratio.
Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50. [2022]Label="PURPOSE">We report the first 5-year follow-up of any first-line phase III immunotherapy trial for non-small-cell lung cancer (NSCLC). KEYNOTE-024 (ClinicalTrials.gov identifier: NCT02142738) is an open-label, randomized controlled trial of pembrolizumab compared with platinum-based chemotherapy in patients with previously untreated NSCLC with a programmed death ligand-1 (PD-L1) tumor proportion score of at least 50% and no sensitizing EGFR or ALK alterations. Previous analyses showed pembrolizumab significantly improved progression-free survival and overall survival (OS).
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. [2022]In the global FLAURA study, first-line osimertinib, a third-generation irreversible tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR), significantly improved progression-free survival (PFS) and overall survival (OS) versus comparator EGFR TKIs in patients with EGFR mutation-positive (EGFRm) advanced non-small-cell lung cancer (NSCLC).
Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Among patients with resected, epidermal growth factor receptor (EGFR)-mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), adjuvant osimertinib therapy, with or without previous adjuvant chemotherapy, resulted in significantly longer disease-free survival than placebo in the ADAURA trial. We report the results of the planned final analysis of overall survival.