N/A
N=10,256
Symptom Management Implementation of Patient Reported Outcomes in Oncology
Other Cancer · Gastrointestinal Cancer · Thoracic Cancer · Gynecologic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03850912 ↗Enrolled (actual)
10,256
Serious AEs
—
Results posted
Aug 2025
Primary outcome: Primary: Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 — 5.8; 6.9; 5.3; 5.8 percentage of patients with event — p=0.214
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stakeholder Survey (Control Period) (Other); Stakeholder Survey (Intervention Period) (Other); Qualitative Interview (Other); SASS Questionnaire (Other); eSyM (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 |
5.8; 6.9; 5.3; 5.8; 5.4; 6.2 | 0.214 |
| SECONDARY Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90 |
11.6; 13.8; 8.8; 9.7; 9.5; 11.2 | 0.050 |
| SECONDARY Admissions Event Occurrence Status at Day 30 |
10.8; 10.7; 7.7; 8.2; 8.5; 9.1 | 0.978 |
| SECONDARY Admissions Event Occurrence Status at Day 90 |
20.8; 21.9; 12.8; 13.1; 14.7; 16.4 | 0.209 |
| SECONDARY Difference in Fatigue PROMIS Scores Reported by Participants Before and After eSyM Exposure |
57.4; 55.6; 51.1; 49.0 | 0.04 sig |
| SECONDARY Difference in Depression PROMIS Scores Reported by Participants Before and After eSyM Exposure |
50.0; 48.7; 47.9; 46.0 | 0.09 |
| SECONDARY Difference in Anxiety PROMIS Scores Reported by Participants Before and After eSyM Exposure |
52.4; 50.2; 49.9; 47.4 | 0.17 |
| SECONDARY Difference in Pain Interference PROMIS Scores Reported by Participants Before and After eSyM Exposure |
54.0; 52.7; 52.7; 51.8 | 0.2 |
| SECONDARY Difference in Self-Efficacy PROMIS Scores Reported by Participants Before and After eSyM Exposure |
47.6; 47.3; 50.1; 50.8 | 0.23 |
| SECONDARY Difference in Physical Function PROMIS Scores Reported by Participants Before and After eSyM Exposure |
42.3; 42.3; 47.9; 47.5 | 0.22 |
| SECONDARY Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders) |
5.7; 7.7; 5.1; 6.7; 5.3; 7.1 | <0.001 sig |
| SECONDARY Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders) |
12.1; 15.1; 8.6; 11.2; 9.9; 12.9 | <0.001 sig |
| SECONDARY Admissions Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders) |
7.5; 12.9; 6.2; 10.5; 6.7; 11.5 | <0.001 sig |
| SECONDARY Admissions Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders) |
18.8; 23.7; 10.8; 16.1; 13.7; 19.4 | <0.001 sig |
Summary
Deficits in the management of common symptoms cause substantial morbidity for cancer patients.Because the health care delivery system is structured to be reactive and not proactive, there are missed opportunities to optimize symptom control. Growth in Internet access and proliferation of smartphones has created an opportunity to re-engineer cancer care delivery. Electronic symptom tracking and feedback is a promising strategy to improve symptom control. Electronic patient reported outcome (ePRO) monitoring of cancer symptoms has been shown to decrease symptom burden, improve quality of life, reduce acute care and even extend survival. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM
Eligibility Criteria
Inclusion Criteria
Stakeholder Feedback and Stakeholder Qualitative Interviews Population:
- Age ≥ 18 years
- The potential stakeholders are: patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff
Cluster Randomized Trial, Patient QualitativeInterviews, Pilot Testing & SASS Questionnaire Population:
- Age ≥ 18 years
- Priority population will be patients who meet one of the following:
- Suspected thoracic cancer [lung or bronchus] AND is inpatient following thoracic surgery.
- Suspected gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND is inpatient following gastrointestinal surgery.
- Suspected gynecologic cancer [ovary, uterus, or cervix] AND is inpatient following gynecologic surgery.
- Diagnosis of thoracic cancer [lung or bronchus] AND scheduled to start a new treatment plan for thoracic cancer.
- Diagnosis of gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND scheduled to start a new treatment plan for gastrointestinal cancer.
- Diagnosis of gynecologic cancer [ovary, uterus, or cervix] AND scheduled to start a new treatment plan for gynecologic cancer.
- Total population allowed to use eSyM:
- Any patient at any participating site.
Exclusion Criteria
- Participants not meeting the inclusion critera above.
Data sourced from ClinicalTrials.gov (NCT03850912). 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.