N/A
N=476
Behavioral Economic Strategies to Improve PRO Adherence
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06013176 ↗Enrolled (actual)
476
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: PRO Adherence — 50.0; 56.9; 34.9 pct. assigned questionnaires completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Encounter-based PRO monitoring (Other); Remote PRO monitoring (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PRO Adherence |
50.0; 56.9; 34.9 | — |
| SECONDARY Percent of Patients With at Least One Note Documenting PROs During Study Period |
67; 82; 96 | — |
| SECONDARY Percent of Patients With at Least One Note Documenting PROs Per Month During Study Period |
20; 16; 32 | — |
| SECONDARY Time to Alert Response (for Arms 2 and 3 Only) |
1.24; 1.20 | — |
| SECONDARY Percent of Patients Who Trigger an Alert for Triage Nurses (for Arms 2 and 3 Only) |
71; 84 | — |
| SECONDARY Acute Care Utilization |
48; 45; 51 | — |
| SECONDARY Treatment Modifications |
43; 35; 29 | — |
| SECONDARY Duration of Therapy |
56.82; 55.94; 53.66 | — |
Summary
The main purpose of this research study is to evaluate the implementation and effectiveness of patient- and nurse-directed strategies across in-clinic and remote patient reported outcome (PRO) monitoring settings, using a three-arm pragmatic cluster randomized controlled trial. Additionally, the goal is to evaluate moderators of implementation effects on PRO monitoring.
Eligible patients will be randomized independently to: (1) usual practice (i.e., encounter-based PRO administration via patient portal or tablet); (2) encounter-based PRO monitoring with patient reminders and nurse alerts; or (3) remote PRO monitoring with patient reminders and nurse alerts. The investigators hypothesize that nudges to patients and alerts to nurses will improve patient-level PRO completion and clinician-level PRO engagement.
Eligibility Criteria
Inclusion Criteria
- Patients must initiate a new line of systemic cancer therapy (i.e., intravenous chemotherapy or immunotherapy) at a participating Implementation Lab site
Exclusion Criteria
- Patient opts out of pragmatic research
Data sourced from ClinicalTrials.gov (NCT06013176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.