Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice

Sponsor
Hoffmann-La Roche
Study ID
NCT05694013
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roche DPM Module — DEVICE
    Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support
  • Atezolizumab SC — DRUG
    Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)
  • Local SOC support — OTHER
    Participants will receive local SOC support

Study Details

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.

Key Dates

Start date
Feb 27, 2023
Status verified
Oct 2025
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

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 ]

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