NCT04809740

✓ Unanimous Initial: N/A Requery: N/A — This is a single-group implementation study without a concurrent control group, making it an observational/non-randomized study rather than an RCT.

✓ Unanimous Initial: fully powered RCT Requery: N/A — This is a single-group implementation study evaluating the deployment of an intervention across all eligible cancer patients, not a randomized controlled trial.

✓ Unanimous Initial: fully powered RCT Requery: N/A — This study is observational as it focuses on evaluating the implementation and impact of an intervention across multiple sites without randomization, despite using an intervention model.

✓ Unanimous Initial: yes Requery: no — The intervention is a single-modality health service intervention (navigator-delivered electronic patient-reported outcome [ePRO] symptom monitoring) without combining distinctly different intervention categories.

✓ Unanimous Initial: no Requery: yes — The intervention combines multiple distinct components including navigator-delivered patient support, electronic patient-reported outcome monitoring technology, automated clinical alerts, and systematic symptom management protocols that work together as an integrated care delivery system. Thinking: no — This is a single-modality electronic symptom monitoring system (Home ePRO) delivered through navigators, not a multi-component intervention combining different therapeutic categories.

✓ Unanimous Initial: no Requery: yes — The intervention combines electronic patient-reported outcome (ePRO) monitoring with navigator assistance, integrating technological and organizational components, making it a complex, multi-component intervention. Thinking: no — The study implements one health-service intervention—navigator-delivered electronic symptom monitoring—without combining it with separate pharmacologic, psychological, educational, or other distinct components.

✓ Unanimous Initial: no Requery: no — The study evaluates the implementation and impact of an ePRO symptom monitoring and management intervention rather than testing a screening tool to identify palliative care needs.

✓ Unanimous Initial: yes Requery: no — This study is implementing and evaluating a navigator-delivered electronic patient-reported outcome (ePRO) home symptom monitoring system, not testing a screening tool to identify palliative care needs.

✓ Unanimous Initial: yes Requery: no — The trial evaluates the implementation of a home symptom monitoring system (Home ePRO) and not a screening tool as the core intervention.

✓ Unanimous Initial: yes Requery: yes — The study evaluates the impact of Home ePRO (electronic patient-reported outcomes) on symptom monitoring, explicitly listing distress and depression as patient-level outcomes in Aim 3.

✓ Unanimous Initial: no Requery: yes — The study evaluates patient-level outcomes including distress and depression, which are symptom measures, through Home ePRO (electronic patient-reported outcomes) symptom monitoring.

✓ Unanimous Initial: yes Requery: yes — The trial involves assessing symptoms through Home ePRO, including depression and distress, which are symptom measures.

✓ Unanimous Initial: no

✓ Unanimous Initial: no Requery: yes — The study explicitly mentions that Home ePRO monitoring was previously associated with improved quality of life in Basch's trials, and the current study aims to assess similar clinical outcomes including functional status as part of evaluating the implementation impact. Thinking: no — The trial measures implementation outcomes and clinical outcomes (functional status, distress, depression, utilization, cost, survival) but does not mention any validated quality of life instruments.

✓ Unanimous Initial: yes Requery: no — The trial focuses on symptom monitoring rather than specific use of validated quality of life instruments such as EORTC QLQ-C30 or SF-36. Thinking: no — The protocol lists functional status and symptom/distress measures but does not specify any validated quality-of-life instruments such as EORTC QLQ, FACT, EQ-5D, or SF-36.