Clinical trial NCT05694013: Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cancer
Keywords: Remote Patient Monitoring, Digital Patient Monitoring, Symptom Monitoring, Digital Health
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

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

* Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* History of leptomeningeal disease
* Uncontrolled or symptomatic hypercalcemia
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Active tuberculosis
* Significant cardiovascular disease
* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact participant safety
* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
* Prior allogeneic stem cell or solid organ transplantation
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
* Current treatment with anti-viral therapy for HBV
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-α \[TNF-α\] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
* Pregnancy or breastfeeding
* Known allergy or hypersensitivity to hyaluronidase, bee or vespid venom, or any other ingredient in the formulation of rHuPH20
* Pathology (e.g., lower extremity edema, cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous lymph node dissection, etc.) that could interfere with any protocol-specified outcome assessment
* Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to randomization
* Participants currently using another DPM or ePRO solution for symptom management and/or reporting

Primary outcomes:
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 (Cohort A)
timeFrame: Baseline, Week 12
measure: Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B)
timeFrame: Cycle 6 (cycle length = 21 days)
Secondary outcomes:
measure: Number of hospitalizations due to serious adverse events (SAEs) (Cohort A)
timeFrame: Up to approximately 28 months
measure: Number of cumulative days hospitalized due to SAEs (Cohort A)
timeFrame: Up to approximately 28 months
measure: Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A)
timeFrame: Up to approximately 28 months
measure: 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 (Cohort A)
timeFrame: Up to approximately 28 months
measure: Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A)
timeFrame: Up to approximately 28 months
measure: Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A)
timeFrame: Up to approximately 28 months
measure: Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A)
timeFrame: Up to approximately 28 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Traralgon
country: Australia
facility: Latrobe Regional Hospital
state: Victoria
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz
city: Klagenfurt am Worthersee
country: Austria
facility: Klinikum Klagenfurt am Wörtersee
city: Aschaffenburg
country: Germany
facility: Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
city: Stade
country: Germany
facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -
city: Wuppertal
country: Germany
facility: Helios Klinik Wuppertal
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
city: Genève
country: Switzerland
facility: Hôpital Universitaire de Genève (HUG)
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
affiliation: Hoffmann-LaRoche
name: Clinical Trials
role: STUDY_DIRECTOR
References: