Symptom Management Implementation of Patient Reported Outcomes in Oncology

NCT03850912 | Completed Results

• 2 other identifiers: 18-7341UM1CA233080-01
• Study Type: interventional
• Target: 42,808
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Other Cancer; Gastrointestinal Cancer; Thoracic Cancer; Gynecologic Cancer

Keywords

Other Cancer; Digital health; Patient reported outcomes; Symptom management

Outcome Measures

Primary Outcomes (1)

• Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30

  The primary study outcome of the stepped wedge cluster RCT (randomized controlled trial) is the EDTR rate. This outcome will be defined in relation to the date of discharge from hospital (surgical cohort) or the initiation date of a new intravenous chemo regimen (medical oncology cohort). This is a binary outcome and we will analyze the absolute difference and odds ratio for the medical oncology and surgical cohorts combined and independently.

  30 days

Secondary Outcomes (13)

• Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90

  90 days

• Admissions Event Occurrence Status at Day 30

  30 Days

• Admissions Event Occurrence Status at Day 90

  90 Days

• Difference in Fatigue PROMIS Scores Reported by Participants Before and After eSyM Exposure

  30-90 days before and after eSyM go-live

• Difference in Depression PROMIS Scores Reported by Participants Before and After eSyM Exposure

  30-90 days before and after eSyM go-live

Study Arms (9)

Stakeholder Feedback (Control Period)

OTHER

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

Other: Stakeholder Survey (Control Period)

Stakeholder Feedback (Intervention Period)

OTHER

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

Other: Stakeholder Survey (Intervention Period)

SASS Questionnaire Participants (Control Period)

OTHER

A subset of trial control patients were asked to complete a research questionnaire called the SASS Questionnaire before the roll-out of eSyM to assess patient outcomes including self-efficacy, attainment of informational needs, symptom burden, and satisfaction with care.

Other: SASS Questionnaire

SASS Questionnaire Participants (Intervention Period)

OTHER

A subset of trial intervention patients were asked to complete a research questionnaire called the SASS Questionnaire after the roll-out of eSyM to assess patient outcomes including self-efficacy, attainment of informational needs, symptom burden, and satisfaction with care.

Other: SASS Questionnaire

Patient Qualitative Interviews

OTHER

A subset of trial intervention patients were asked to participate in a one-time patient interview to provide feedback on facilitators and barriers to eSyM implementation and adoption after the roll-out of eSyM.

Other: Qualitative Interview

Stakeholder Qualitative Interviews

OTHER

A subset of eligible stakeholders at each site were asked to participate in a one-time interview to provide feedback on facilitators and barriers to eSyM implementation and adoption after the roll-out of eSyM.

Other: Qualitative Interview

Pilot Testing

OTHER

A subset of control patients at each site were selected to pilot test the eSyM intervention prior to trial start.

Other: eSyM

Cluster Randomized Trial (Control Patients)

NO INTERVENTION

These patients (and/or proxy) were seen at a participating site prior to the trial rollout of eSyM and were not exposed to the eSyM intervention.

Cluster Randomized Trial (Intervention Patients)

EXPERIMENTAL

These patients (and/or proxy) were seen at a participating site after the trial rollout of eSyM and were exposed to the eSyM intervention.

Other: eSyM

Interventions

Stakeholder Survey (Control Period) OTHER

Before eSyM go-live, study team members from each site will solicit input via emailed survey, remote meetings and/or in-person meeting on the use of ePROs in oncology from stakeholders to obtain input regarding adaptation, anticipated challenges, and implementation.

Stakeholder Feedback (Control Period)

Stakeholder Survey (Intervention Period) OTHER

After eSyM go-live and on an ongoing basis, we will evaluate the implementation process at each of the sites with a focus on adoption, appropriateness, acceptability, sustainability, penetration, and scalability. We will do so through emailed surveys and/or discussions with health system leadership, clinicians, clinic support staff, and informatics/IT staff.

Stakeholder Feedback (Intervention Period)

Qualitative Interview OTHER

A small subset of patients and stakeholders were invited to take part in qualitative interviews after the eSyM trial rollout.

Patient Qualitative Interviews; Stakeholder Qualitative Interviews

SASS Questionnaire OTHER

A subset of control and intervention patients will be asked to complete a research questionnaire called the "SASS Questionnaire" asking about their Self-efficacy, Attainment of information needs, Symptom burden, and Satisfaction with care.

SASS Questionnaire Participants (Control Period); SASS Questionnaire Participants (Intervention Period)

eSyM OTHER

The electronic symptom management (eSyM) program is the EHR-integrated ePRO program being evaluated through this trial.

Cluster Randomized Trial (Intervention Patients); Pilot Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• RTI International: collaborator
• Baptist Memorial Health Care Corporation: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• MaineHealth: collaborator
• West Virginia University: collaborator
• Lifespan: collaborator

Study Sites (6)

Maine Medical Center

Portland, Maine, 04101, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Brown University Health (formerly Lifespan Cancer Institute)

Providence, Rhode Island, 02905, United States

Location

Baptist Memoiral HealthCare

Memphis, Tennessee, 38120, United States

Location

West Virginia University Medical Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (21)

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• Cleeland 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 BACKGROUND

• Hofman 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 BACKGROUND

• Teunissen 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.

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• Temel 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 BACKGROUND

• Janjan 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.

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• Fleishman SB. Treatment of symptom clusters: pain, depression, and fatigue. J Natl Cancer Inst Monogr. 2004;(32):119-23. doi: 10.1093/jncimonographs/lgh028.

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• Hernandez-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.

  PMID: 28657940 BACKGROUND

• Kenzik KM, Ganz PA, Martin MY, Petersen L, Hays RD, Arora N, Pisu M. How much do cancer-related symptoms contribute to health-related quality of life in lung and colorectal cancer patients? A report from the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium. Cancer. 2015 Aug 15;121(16):2831-9. doi: 10.1002/cncr.29415. Epub 2015 Apr 17.

  PMID: 25891437 BACKGROUND

• Hassett MJ, Wong S, Osarogiagbon RU, Bian J, Dizon DS, Jenkins HH, Uno H, Cronin C, Schrag D; SIMPRO Co-Investigators. Implementation of patient-reported outcomes for symptom management in oncology practice through the SIMPRO research consortium: a protocol for a pragmatic type II hybrid effectiveness-implementation multi-center cluster-randomized stepped wedge trial. Trials. 2022 Jun 16;23(1):506. doi: 10.1186/s13063-022-06435-1.

  PMID: 35710449 BACKGROUND

• Hassett MJ, Cronin C, Tsou TC, Wedge J, Bian J, Dizon DS, Hazard-Jenkins H, Osarogiagbon RU, Wong S, Basch E, Austin T, McCleary N, Schrag D. eSyM: An Electronic Health Record-Integrated Patient-Reported Outcomes-Based Cancer Symptom Management Program Used by Six Diverse Health Systems. JCO Clin Cancer Inform. 2022 Jan;6:e2100137. doi: 10.1200/CCI.21.00137.

  PMID: 34985914 RESULT

• Paudel R, Enzinger AC, Uno H, Cronin C, Wong SL, Dizon DS, Hazard Jenkins H, Bian J, Osarogiagbon RU, Jensen RE, Mitchell SA, Schrag D, Hassett MJ. Effects of a change in recall period on reporting severe symptoms: an analysis of a pragmatic multisite trial. J Natl Cancer Inst. 2024 Jul 1;116(7):1137-1144. doi: 10.1093/jnci/djae049.

  PMID: 38445744 RESULT

• Paudel R, Tramontano AC, Cronin C, Wong SL, Dizon DS, Jenkins HH, Bian J, Osarogiagbon RU, Schrag D, Hassett MJ. Assessing Patient Readiness for an Electronic Patient-Reported Outcome-Based Symptom Management Intervention in a Multisite Study. JCO Oncol Pract. 2024 Jan;20(1):77-84. doi: 10.1200/OP.23.00339. Epub 2023 Nov 27.

  PMID: 38011613 RESULT

• Ivatury SJ, Hazard-Jenkins HW, Brooks GA, McCleary NJ, Wong SL, Schrag D. Translation of Patient-Reported Outcomes in Oncology Clinical Trials to Everyday Practice. Ann Surg Oncol. 2020 Jan;27(1):65-72. doi: 10.1245/s10434-019-07749-2. Epub 2019 Aug 26.

  PMID: 31452053 RESULT

• Phillips JD, Wong SL. Patient-Reported Outcomes in Surgical Oncology: An Overview of Instruments and Scores. Ann Surg Oncol. 2020 Jan;27(1):45-53. doi: 10.1245/s10434-019-07752-7. Epub 2019 Aug 28.

  PMID: 31463699 RESULT

• Hassett M, Dias S, Cronin C, Schrag D, McCleary N, Simpson J, Poirier-Shelton T, Bian J, Reich J, Dizon D, Begnoche M, Jenkins HH, Tasker L, Wong S, Pearson L, Paudel R, Osarogiagbon RU. Strategies for implementing an electronic patient-reported outcomes-based symptom management program across six cancer centers. BMC Health Serv Res. 2024 Nov 12;24(1):1386. doi: 10.1186/s12913-024-11536-5.

  PMID: 39533260 RESULT

• Paudel R, Dias S, Wade CG, Cronin C, Hassett MJ. Use of Patient-Reported Outcomes in Risk Prediction Model Development to Support Cancer Care Delivery: A Scoping Review. JCO Clin Cancer Inform. 2024 Nov;8:e2400145. doi: 10.1200/CCI-24-00145. Epub 2024 Nov 1.

  PMID: 39486014 RESULT

• Mallow J, Bailey A, Tasker L, Hazard H, Hassett M, Cronin C, Paudel R, Bian J, Dizon DS, Osarogiagbon RU, Schrag D, Wong SL. Perceptions of an Electronic Patient Symptom Reporting Tool by Clinicians. Comput Inform Nurs. 2026 Jan 1;44(1):e01313. doi: 10.1097/CIN.0000000000001313.

  PMID: 40257368 RESULT

• Beqari J, Hurd J, Tramontano AC, Cronin C, Potter A, Wong S, Schrag D, Dizon DS, Bian J, Osarogiagbon RU, Hazard-Jenkins H, Phillips JD, Abbas AE, Warikoo IM, Anderson M, Seastedt KP, Lanuti M, Colson YL, Wright CD, Hassett M, Jeffrey Yang CF. The implementation of an electronic symptom management system to monitor postoperative pain in thoracic surgery patients: A multicenter evaluation. JTCVS Open. 2025 Feb 25;25:485-499. doi: 10.1016/j.xjon.2025.02.010. eCollection 2025 Jun.

  PMID: 40631021 RESULT

• Cronin, C., Barrett, F., Dias, S., Wong, S. L., Pearson, L., Hazard-Jenkins, H., Bian, J. J., Dizon, D. S., Osarogiagbon, R. U., Schrag, D., & Hassett, M. J. (2024). Electronic Patient-Reported Outcomes in Oncology: Lessons from Six Cancer Centers. NEJM Catalyst Innovations in Care Delivery, 5(2). https://doi.org/10.1056/cat.23.0331

  RESULT

• Kuharic M, Merle JL, Cella D, Mitchell SA, DiMartino L, Ridgeway JL, Dizon DS, Paudel R, Austin JD, Wong SL, Flores AM, Cheville AL, Smith JD; IMPACT Consortium. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning. Implement Sci Commun. 2025 Jun 16;6(1):72. doi: 10.1186/s43058-025-00756-3.

  PMID: 40524282 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Michael Hassett
• Organization: Dana-Farber Cancer Institute

michael_hassett@dfci.harvard.edu

617-726-5200

Study Officials

• Michael Hassett, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The primary study design is a hybrid effectiveness-implementation stepped-wedge cluster randomized trial involving several different research activities to assess outcomes.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: July 25, 2019
• Primary Completion: March 31, 2023
• Study Completion: June 9, 2025
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: DFCI (Dana-Farber Cancer Institute) - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (6)