- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05694013
Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice (ORIGAMA)
April 23, 2024 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
440
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: MO42720 https://forpatients.roche.com/
- Phone Number: 888-662-6728
- Email: global-roche-genentech-trials@gene.com
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2139
- Recruiting
- Concord Repatriation General Hospital; Oncology
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Queensland
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Birtinya, Queensland, Australia, 4575
- Recruiting
- Sunshine Coast University Hospital; The Adem Crosby Centre
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Victoria
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Clayton, Victoria, Australia, 3168
- Recruiting
- Monash Medical Centre Clayton
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Traralgon, Victoria, Australia, 3844
- Recruiting
- Latrobe Regional Hospital
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Graz, Austria, 8036
- Recruiting
- LKH-Univ. Klinikum Graz
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Klagenfurt, Austria, 9020
- Recruiting
- Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie
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Klagenfurt am Worthersee, Austria, 9020
- Recruiting
- Klinikum Klagenfurt am Wörtersee
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Aschaffenburg, Germany, 63739
- Recruiting
- Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
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Stade, Germany, 21680
- Recruiting
- MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
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Troisdorf, Germany, 53840
- Recruiting
- Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
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Wuppertal, Germany, 42283
- Recruiting
- Helios Klinik Wuppertal; Medizinische Klinik I
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Drammen, Norway, 3019
- Withdrawn
- Vestre Viken HF Drammen; Onkologisk avdeling
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Gjøvik, Norway, 2819
- Withdrawn
- Sykehuset Innlandet HF Gjøvik; Department of Oncology and Radiotherapy
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Lørenskog, Norway, 1478
- Withdrawn
- Akershus Universitetssykehus HF; Avdeling for forskning, Medisinsk divisjon
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Barcelona, Spain, 08003
- Active, not recruiting
- Hospital del Mar; Servicio de Oncologia
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Barcelona, Spain, 08036
- Active, not recruiting
- Hospital Clínic i Provincial; Servicio de Hematología y Oncología
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Jaen, Spain, 23007
- Active, not recruiting
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
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Valencia, Spain, 46014
- Withdrawn
- Hospital General Universitario de Valencia; Servicio de oncologia
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Zaragoza, Spain, 50009
- Withdrawn
- Hospital Universitario Miguel Servet; Servicio Oncologia
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spain, 07198
- Withdrawn
- Hospital Son Llatzer; Servicio de Oncologia
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Malaga
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Málaga, Malaga, Spain, 29010
- Recruiting
- Hospital Regional Universitario de Malaga; Oncologia
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Aarau, Switzerland, 5000
- Recruiting
- Hirslanden Medical Center - Tumorzentrum
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Genève, Switzerland, 1211
- Recruiting
- Hôpital Universitaire de Genève (HUG)
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Lausanne, Switzerland, 1011
- Recruiting
- CHUV; Departement d'Oncologie
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Zürich, Switzerland, 8063
- Recruiting
- Stadtspital Triemli; Klinik für medizinische Onkologie und Hämatologie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support
Participants will receive local SOC support
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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.
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Participants will receive local SOC support
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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.
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Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support
Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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)
Time Frame: Baseline, Week 12
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Baseline, Week 12
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Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B)
Time Frame: Cycle 6 (cycle length = 21 days)
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Cycle 6 (cycle length = 21 days)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of hospitalizations due to serious adverse events (SAEs) (Cohort A)
Time Frame: Up to approximately 28 months
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Up to approximately 28 months
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Number of cumulative days hospitalized due to SAEs (Cohort A)
Time Frame: Up to approximately 28 months
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Up to approximately 28 months
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Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A)
Time Frame: Up to approximately 28 months
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Up to approximately 28 months
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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)
Time Frame: Up to approximately 28 months
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Up to approximately 28 months
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Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A)
Time Frame: Up to approximately 28 months
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Up to approximately 28 months
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Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A)
Time Frame: Up to approximately 28 months
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Up to approximately 28 months
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Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A)
Time Frame: Up to approximately 28 months
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Up to approximately 28 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-LaRoche
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2023
Primary Completion (Estimated)
July 7, 2024
Study Completion (Estimated)
July 7, 2026
Study Registration Dates
First Submitted
December 20, 2022
First Submitted That Met QC Criteria
January 19, 2023
First Posted (Actual)
January 23, 2023
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MO42720
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org).
Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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