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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
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)
Participants will receive local SOC support
Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Monash Medical Centre Clayton
Clayton, Victoria, Australia
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
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)
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.
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Latrobe Regional Hospital
Traralgon, Victoria, Australia
Lkh-Univ. Klinikum Graz
Graz, Austria
Klinikum Klagenfurt am Wörtersee
Klagenfurt, Austria
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, Germany
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -
Stade, Germany
Helios Klinik Wuppertal
Wuppertal, Germany
Hospital del Mar
Barcelona, Spain
...and 4 more locations
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)
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)
Number of Cumulative Days Hospitalized Due to SAEs
Time frame: Up to approximately 16 months