Interventional Platform Study Investigating the Impact of Digital Health Solutions on Health Outcomes and Health-Care Resource Utilization in Participants Receiving Systemic Treatment in Clinical Practice
Overview
- Phase
- Phase 2
- Intervention
- Roche DPM Module
- Conditions
- Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 49
- Locations
- 14
- Primary Endpoint
- Mean Difference in Change of Week 12 Value From Baseline of Participant-reported Total Symptom Interference Score From the MD Anderson Symptom Inventory (MDASI) Core Items
- Status
- Terminated
- Last Updated
- 6 months ago
Overview
Brief Summary
This study will evaluate the clinical impact and utility of digital health solutions (DHS) on health outcomes and health-care resource utilization in people receiving systemic anti-cancer treatment (approved or non-approved) in clinical practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All Participants
- •Email address, access to an internet-capable device (smartphone, tablet, or PC), and access to an internet connection
- •Inclusion Criteria: Cohort A
- •Histologically confirmed diagnosis for mNSCLC, ES-SCLC, or HCC (Child Pugh A)
- •Systemic therapy naive
- •Prescribed an atezolizumab IV regimen
- •Easter Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •Inclusion Criteria: Cohort B
- •Complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) NSCLC
- •PD-L1 positive
Exclusion Criteria
- •All Participants
- •Any physical or cognitive condition that would prevent the participant from using the DHS
- •Participants not proficient with any of the available DHS language translations or with psychiatric/neurologic disorders or any condition that may impact the participant's ability to use the DPM solution
- •Currently participating in another interventional trial
- •History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
- •Exclusion Criteria: Cohort A
- •Concomitant anti-cancer therapy at the time of starting atezolizumab (IV) regimen on the index date which is not part of a locally approved combination therapy with atezolizumab
- •Participants not receiving atezolizumab, but an atezolizumab biosimilar or non-comparable biologic
- •Participants currently using another DPM or ePRO solution for symptom management and/or reporting
- •Exclusion Criteria: Cohort B
Arms & Interventions
Cohort A - Arm 1
Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who are prescribed an anticancer regimen including intravenous (IV) atezolizumab will use the Roche Digital Patient Monitoring (DPM) Module along with local standard of care (SOC) support.
Intervention: Roche DPM Module
Cohort A - Arm 1
Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who are prescribed an anticancer regimen including intravenous (IV) atezolizumab will use the Roche Digital Patient Monitoring (DPM) Module along with local standard of care (SOC) support.
Intervention: Local SOC support
Cohort A - Arm 2
Participants with mNSCLC, ES-SCLC, and HCC who are prescribed an anticancer regimen including IV atezolizumab will receive local SOC support.
Intervention: Local SOC support
Cohort B
Participants with resected Stage IIB-IIIB NSCLC will use the Roche DPM Module along with subcutaneous (SC) atezolizumab in both the hospital and flexcare (home) setting.
Intervention: Roche DPM Module
Cohort B
Participants with resected Stage IIB-IIIB NSCLC will use the Roche DPM Module along with subcutaneous (SC) atezolizumab in both the hospital and flexcare (home) setting.
Intervention: Atezolizumab SC
Outcomes
Primary Outcomes
Mean Difference in Change of Week 12 Value From Baseline of Participant-reported Total Symptom Interference Score From the MD Anderson Symptom Inventory (MDASI) Core Items
Time Frame: Baseline, Week 12
The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life.
Secondary Outcomes
- Change From Baseline in Global Health Status Score/Quality of Life Score (GHS/QoL) From the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL(Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days))
- Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument(Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days))
- Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items(Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days))
- Number of Cumulative Days Hospitalized Due to SAEs(Up to approximately 16 months)