Cancer
Conditions
Keywords
Remote Patient Monitoring, Digital Patient Monitoring, Symptom Monitoring, Digital Health
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.
Interventions
DEVICERoche DPM Module
Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support
DRUGAtezolizumab SC
Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)
OTHERLocal SOC support
Participants will receive local SOC support
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy treatment * ECOG Performance Status of 0 or 1 * Adequate hematologic and end-organ function * For participants receiving therapeutic anticoagulation: stable anticoagulant regimen * Negative for hepatitis B virus (HBV) or hepatitis C virus (HCV)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | The European Organisation for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The EORTC item library 6 (IL6) GHS/QoL consists of only the GHS and QoL items from the EORTC QLQ-C30. The raw score is calculated as the value of both answers, scored on a 7-point scale that ranges from 1 (very poor) to 7 (excellent), then a linear transformation is applied to produce a score between 0-100. Higher scores indicate a higher QoL. |
| 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) | The EQ-5D-5L is used to calculate a health status utility score for use in health economic analyses. The questionnaire is designed to capture the participant's current health status. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The score range is 0-100, with higher scores indicating better outcomes. |
| 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) | 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. |
| Number of Cumulative Days Hospitalized Due to SAEs | Up to approximately 16 months | — |
Countries
Australia, Austria, Germany, Spain, Switzerland
Participant flow
Recruitment details
Participants with extensive- stage small-cell lung carcinoma (ES-SCLC) or hepatocellular carcinoma (HCC) or non-small cell lung carcinoma (NSCLC) that are prescribed a locally-approved anti-cancer regimen containing IV atezolizumab.
Participants by arm
| Arm | Count |
|---|---|
| Atezolizumab Regimen Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support. | 25 |
| Atezolizumab Regimen + DPM Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support. | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 2 |
| Overall Study | Participant Decision | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Progressive Disease | 0 | 1 |
| Overall Study | Study Terminated by Sponsor | 12 | 17 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Atezolizumab Regimen + DPM | Total | Atezolizumab Regimen |
|---|---|---|---|
| Age, Continuous | 62.0 Years STANDARD_DEVIATION 8.5 | 65.1 Years STANDARD_DEVIATION 8.4 | 68.1 Years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 31 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 46 Participants | 23 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 33 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 25 | 2 / 24 |
| other Total, other adverse events | 18 / 25 | 22 / 24 |
| serious Total, serious adverse events | 10 / 25 | 13 / 24 |
Outcome results
Primary
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
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.
Time frame: Baseline, Week 12
Population: The ITT population included all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab Regimen | 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 | Baseline | 3.33 Units on a scale |
| Atezolizumab Regimen | 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 | Cycle 5 Day 1 (Week 12) | 3.00 Units on a scale |
| Atezolizumab Regimen + DPM | 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 | Baseline | 3.08 Units on a scale |
| Atezolizumab Regimen + DPM | 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 | Cycle 5 Day 1 (Week 12) | 2.33 Units on a scale |
Secondary
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
The European Organisation for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The EORTC item library 6 (IL6) GHS/QoL consists of only the GHS and QoL items from the EORTC QLQ-C30. The raw score is calculated as the value of both answers, scored on a 7-point scale that ranges from 1 (very poor) to 7 (excellent), then a linear transformation is applied to produce a score between 0-100. Higher scores indicate a higher QoL.
Time frame: 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)
Population: The ITT population included all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab Regimen | 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 | 66.67 Units on a scale |
| Atezolizumab Regimen | 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 | Cycle 3 Day 1 | 66.67 Units on a scale |
| Atezolizumab Regimen | 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 | Cycle 5 Day 1 | 62.50 Units on a scale |
| Atezolizumab Regimen | 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 | Cycle 7 Day 1 | 66.67 Units on a scale |
| Atezolizumab Regimen | 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 | Cycle 9 Day 1 | 62.50 Units on a scale |
| Atezolizumab Regimen | 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 | Long Term Follow Up (Week 28) | 75.00 Units on a scale |
| Atezolizumab Regimen + DPM | 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 | 66.67 Units on a scale |
| Atezolizumab Regimen + DPM | 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 | Cycle 9 Day 1 | 83.33 Units on a scale |
| Atezolizumab Regimen + DPM | 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 | Cycle 3 Day 1 | 58.33 Units on a scale |
| Atezolizumab Regimen + DPM | 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 | Cycle 7 Day 1 | 83.33 Units on a scale |
| Atezolizumab Regimen + DPM | 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 | Cycle 5 Day 1 | 70.83 Units on a scale |
Secondary
Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items
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.
Time frame: 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)
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab Regimen | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Baseline | 3.33 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 3 Day 1 | 2.67 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 5 Day 1 | 3.00 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 7 Day 1 | 1.50 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 9 Day 1 | 1.67 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Long Term Follow Up (Week 28) | 3.42 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Baseline | 3.08 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 9 Day 1 | 1.17 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 3 Day 1 | 3.00 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 7 Day 1 | 3.17 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | Cycle 5 Day 1 | 2.33 Units on a scale |
Secondary
Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument
The EQ-5D-5L is used to calculate a health status utility score for use in health economic analyses. The questionnaire is designed to capture the participant's current health status. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The score range is 0-100, with higher scores indicating better outcomes.
Time frame: 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)
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab Regimen | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Baseline | 71.00 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 3 Day 1 | 65.00 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 5 Day 1 | 78.00 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 7 Day 1 | 67.50 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 9 Day 1 | 67.50 Units on a scale |
| Atezolizumab Regimen | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Long Term Follow Up (Week 28) | 70.00 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Baseline | 83.50 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 9 Day 1 | 90.00 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 3 Day 1 | 59.00 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 7 Day 1 | 65.00 Units on a scale |
| Atezolizumab Regimen + DPM | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | Cycle 5 Day 1 | 85.00 Units on a scale |
Secondary
Number of Cumulative Days Hospitalized Due to SAEs
Time frame: Up to approximately 16 months
Population: The ITT population consisted of all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab Regimen | Number of Cumulative Days Hospitalized Due to SAEs | 11.0 Days |
| Atezolizumab Regimen + DPM | Number of Cumulative Days Hospitalized Due to SAEs | 4.0 Days |