Clinical trial · Interventional
Symptom Management Implementation of Patient Reported Outcomes in Oncology
SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Other Cancer | Digestive System Neoplasm | PROBABILISTIC | 0.70 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eSyM | Other | — | UNRESOLVED |
| Qualitative Interview | Other | — | UNRESOLVED |
| SASS Questionnaire | Other | — | UNRESOLVED |
| Stakeholder Survey (Control Period) | Other | — | UNRESOLVED |
| Stakeholder Survey (Intervention Period) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- OTHER
- label
- Stakeholder Feedback (Control Period)
- description
- Eligible stakeholders at each SIMPRO site were invited to provide feedback through focus groups, team meetings, and surveys before the trial rollout of eSyM to inform development and implementation. Stakeholders included: * patient advisory councils * health system leaders * clinicians * clinic support staff/administration * IT/Informatics
- interventionNames
- Other: Stakeholder Survey (Control Period)
- type
- OTHER
- label
- Stakeholder Feedback (Intervention Period)
- description
- Eligible stakeholders at each SIMPRO site were invited to provide feedback through surveys after the trial rollout of eSyM to inform intervention normalization and sustainability. Stakeholders included: * health system leaders * clinicians * clinic support staff/administration * IT/Informatics
- interventionNames
- Other: Stakeholder Survey (Intervention Period)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (22)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PMID 28055103
- BACKGROUNDCleeland CS. Symptom burden: multiple symptoms and their impact as patient-reported outcomes. J Natl Cancer Inst Monogr. 2007;(37):16-21. doi: 10.1093/jncimonographs/lgm005. PMID 17951226
- BACKGROUNDHofman M, Ryan JL, Figueroa-Moseley CD, Jean-Pierre P, Morrow GR. Cancer-related fatigue: the scale of the problem. Oncologist. 2007;12 Suppl 1:4-10. doi: 10.1634/theoncologist.12-S1-4. PMID 17573451
- BACKGROUNDTeunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manage. 2007 Jul;34(1):94-104. doi: 10.1016/j.jpainsymman.2006.10.015. Epub 2007 May 23. PMID 17509812
- BACKGROUNDTemel JS, Pirl WF, Lynch TJ. Comprehensive symptom management in patients with advanced-stage non-small-cell lung cancer. Clin Lung Cancer. 2006 Jan;7(4):241-9. doi: 10.3816/CLC.2006.n.001. PMID 16512977
- BACKGROUNDJanjan N. Palliation and supportive care in radiation medicine. Hematol Oncol Clin North Am. 2006 Feb;20(1):187-211. doi: 10.1016/j.hoc.2006.01.010. PMID 16580563
- BACKGROUNDFleishman SB. Treatment of symptom clusters: pain, depression, and fatigue. J Natl Cancer Inst Monogr. 2004;(32):119-23. doi: 10.1093/jncimonographs/lgh028. PMID 15263052
- BACKGROUNDHernandez-Boussard T, Graham LA, Desai K, Wahl TS, Aucoin E, Richman JS, Morris MS, Itani KM, Telford GL, Hawn MT. The Fifth Vital Sign: Postoperative Pain Predicts 30-day Readmissions and Subsequent Emergency Department Visits. Ann Surg. 2017 Sep;266(3):516-524. doi: 10.1097/SLA.0000000000002372.