Other CancerSIMPRONCT03850912
Symptom Management Implementation of Patient Reported Outcomes in Oncology
A study testing Stakeholder Survey (Intervention Period), Qualitative Interview and SASS Questionnaire in people with Other Cancer and Gastrointestinal Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Cancer, Gastrointestinal Cancer, Thoracic Cancer
- What is being tested?
- Stakeholder Survey (Intervention Period), Qualitative Interview and SASS Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42,808 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Jul 2019to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- Participants not meeting the inclusion critera above.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Baptist Memoiral HealthCare
Memphis, Tennessee, 38120
West Virginia University Medical Center
Morgantown, West Virginia, 26506
Maine Medical Center
Portland, Maine, 04101
Brown University Health (formerly Lifespan Cancer Institute)
Providence, Rhode Island, 02905
About this study
Official title: SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice
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
Read the detailed description
A multi-disciplinary team of investigators from 6 health systems have formed the Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) Research Center. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM. eSyM is the name of the platform the team will refine, integrate, implement and evaluate. eSyM addresses each of the 4 evidence gaps by:
- Implementing eSyM in cancer centers in small, rural or community-based systems.
- Integrating eSyM into the EHR (electronic health record) of the predominant vendor used nationwide.
- Leveraging evidence-based tools, patient engagement, and population management.
- Executing this work using the Consolidated Framework for Implementation Research across all phases to maximize the chances that eSyM and similar systems achieve their intended goals and decrease the morbidity of cancer treatment at a population level.
This project contains 5 activities:
- Obtain stakeholder feedback
- Build and deploy eSyM
- Pilot test eSyM
- Pragmatic stepped-wedge cluster randomized trial
- Integration of eSyM data to develop algorithms to estimate the risk of experiencing an outcome, including, but not limited to, ED usage and hospitalization among cancer patients
- Being tested
- Stakeholder Survey (Control Period), Stakeholder Survey (Intervention Period), Qualitative Interview, SASS Questionnaire, eSyM
- Keywords
- Other Cancer, Digital health, Patient reported outcomes, Symptom management
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
Qualitative InterviewOther
A small subset of patients and stakeholders were invited to take part in qualitative interviews after the eSyM trial rollout.
SASS QuestionnaireOther
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.
eSyMOther
The electronic symptom management (eSyM) program is the EHR-integrated ePRO program being evaluated through this trial.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: eSyM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (13)
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90
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.
Measured: 90 days
Admissions Event Occurrence Status at Day 30
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.
Measured: 30 Days
Admissions Event Occurrence Status at Day 90
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.
Measured: 90 Days
Difference in Fatigue PROMIS Scores Reported by Participants Before and After eSyM Exposure
Difference in PROMIS fatigue scores between the pre-live and post-live eSyM cohorts. Since the two cohorts were comprised of different patients, comparisons were performed at the population level using mean T-scores. Fatigue was assessed using the PROMIS Fatigue 4-item short form with responses converted to T-scores (score range: 50 indicates the population mean with a standard deviation of 10; decrease in score indicates a positive change). All PROMIS items were scored using the standardized scoring tool kit. The differences in mean T-scores and the corresponding 95% confidence intervals (CI) were calculated for each PROMIS item, comparing the post-live versus pre-live cohort. When comparing group-level change in PROMIS scores, even trivial differences can be statistically significant if the sample size is large enough. The threshold to evaluate within-group change or to make a between-group comparison generally ranges between 2 and 6 T-score points (Terwee et al., 2021).
Measured: 30-90 days before and after eSyM go-live
Difference in Depression PROMIS Scores Reported by Participants Before and After eSyM Exposure
Difference in PROMIS depression scores between the pre-live and post-live eSyM cohorts. Since the two cohorts were comprised of different patients, comparisons were performed at the population level using mean T-scores. Depression was assessed using the PROMIS Emotional Distress-Depression 4-item short form with responses converted to T-scores (score range: 50 indicates the population mean with a standard deviation of 10; decrease in score indicates a positive change). All PROMIS items were scored using the standardized scoring tool kit. The differences in mean T-scores and the corresponding 95% confidence intervals (CI) were calculated for each PROMIS item, comparing the post-live versus pre-live cohort. When comparing group-level change in PROMIS scores, even trivial differences can be statistically significant if the sample size is large enough. The threshold to evaluate within-group change or to make a between-group comparison generally ranges between 2 and 6 T-score points.
Measured: 30-90 days before and after eSyM go-live
Difference in Anxiety PROMIS Scores Reported by Participants Before and After eSyM Exposure
Difference in PROMIS anxiety scores between the pre-live and post-live eSyM cohorts. Since the two cohorts were comprised of different patients, comparisons were performed at the population level using mean T-scores. Anxiety was assessed using the PROMIS Emotional Distress-Anxiety 4-item short form with responses converted to T-scores (score range: 50 indicates the population mean with a standard deviation of 10; decrease in score indicates a positive change). All PROMIS items were scored using the standardized scoring tool kit. The differences in mean T-scores and the corresponding 95% confidence intervals (CI) were calculated for each PROMIS item, comparing the post-live versus pre-live cohort. When comparing group-level change in PROMIS scores, even trivial differences can be statistically significant if the sample size is large enough. The threshold to evaluate within-group change or to make a between-group comparison generally ranges between 2 and 6 T-score points.
Measured: 30-90 days before and after eSyM go-live
Difference in Pain Interference PROMIS Scores Reported by Participants Before and After eSyM Exposure
Difference in PROMIS pain interference scores between the pre-live and post-live eSyM cohorts. Since the two cohorts were comprised of different patients, comparisons were performed at the population level using mean T-scores. Pain interference was assessed using the PROMIS Pain Interference 4-item short form with responses converted to T-scores (score range: 50 indicates the population mean with a standard deviation of 10; decrease in score indicates a positive change). All PROMIS items were scored using the standardized scoring tool kit. The differences in mean T-scores and the corresponding 95% confidence intervals (CI) were calculated for each PROMIS item, comparing the post-live versus pre-live cohort. When comparing group-level change in PROMIS scores, even trivial differences can be statistically significant if the sample size is large enough. The threshold to evaluate within-group change or to make a between-group comparison generally ranges between 2 and 6 T-score points.
Measured: 30-90 days before and after eSyM go-live
Difference in Self-Efficacy PROMIS Scores Reported by Participants Before and After eSyM Exposure
Difference in PROMIS self-efficacy scores between pre-live and post-live eSyM cohorts. Since the two cohorts were comprised of different patients, comparisons were performed at the population level using mean T-scores. Self-efficacy was assessed using the PROMIS Self-Efficacy for Managing Symptoms 8-item short form with responses converted to T-scores (score range: 50 indicates the population mean with a standard deviation of 10; decrease in score indicates a positive change). All PROMIS items were scored using the standardized scoring tool kit. The differences in mean T-scores and the corresponding 95% confidence intervals were calculated for each PROMIS item, comparing the post-live versus pre-live cohort. When comparing group-level change in PROMIS scores, even trivial differences can be statistically significant if the sample size is large enough. The threshold to evaluate within-group change or to make a between-group comparison generally ranges between 2 and 6 T-score points.
Measured: 30-90 days before and after eSyM go-live
Difference in Physical Function PROMIS Scores Reported by Participants Before and After eSyM Exposure
Difference in PROMIS physical function scores between the pre-live and post-live eSyM cohorts. Since the two cohorts were comprised of different patients, comparisons were performed at the population level using mean T-scores. Physical function was assessed using the PROMIS Physical Function 4-item short form with responses converted to T-scores (score range: 50 indicates the population mean with a standard deviation of 10; decrease in score indicates a positive change). All PROMIS items were scored using the standardized scoring tool kit. The differences in mean T-scores and the corresponding 95% confidence intervals (CI) were calculated for each PROMIS item, comparing the post-live versus pre-live cohort. When comparing group-level change in PROMIS scores, even trivial differences can be statistically significant if the sample size is large enough. The threshold to evaluate within-group change or to make a between-group comparison generally ranges between 2 and 6 T-score points).
Measured: 30-90 days before and after eSyM go-live
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)
The secondary study outcome of the stepped wedge cluster RCT (randomized controlled trial) is the difference in the EDTR rate between eSyM responders and non-responders. 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.
NOTE: The total number of intervention participants in this analysis is greater than the number of intervention participants included in the primary analyses (outcomes 1-4). For outcomes outcomes 1-4, we used the patient's first event during the entire study period. To conduct this analysis of eSyM responders, we used the patient's first event during the intervention period. Approximately 10% of patients in this analysis were counted as a control event in the prior analyses.
Measured: 30 days
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)
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.
NOTE: The total number of intervention participants in this analysis is greater than the number of intervention participants included in the primary analyses (outcomes 1-4). For outcomes outcomes 1-4, we used the patient's first event during the entire study period. To conduct this analysis of eSyM responders, we used the patient's first event during the intervention period. Approximately 10% of patients in this analysis were counted as a control event in the prior analyses.
Measured: 90 days
Admissions Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)
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.
NOTE: The total number of intervention participants in this analysis is greater than the number of intervention participants included in the primary analyses (outcomes 1-4). For outcomes outcomes 1-4, we used the patient's first event during the entire study period. To conduct this analysis of eSyM responders, we used the patient's first event during the intervention period. Approximately 10% of patients in this analysis were counted as a control event in the prior analyses.
Measured: 30 Days
Admissions Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)
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.
NOTE: The total number of intervention participants in this analysis is greater than the number of intervention participants included in the primary analyses (outcomes 1-4). For outcomes outcomes 1-4, we used the patient's first event during the entire study period. To conduct this analysis of eSyM responders, we used the patient's first event during the intervention period. Approximately 10% of patients in this analysis were counted as a control event in the prior analyses.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start25 Jul 2019
- Primary completion31 Mar 2023
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Other CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary study design is a hybrid effectiveness-implementation stepped-wedge cluster randomized trial involving several different research activities to assess outcomes.
- Masking
- None (open label)
- Enrolment
- 42,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), RTI International, Baptist Memorial Health Care Corporation, Dartmouth-Hitchcock Medical Center, MaineHealth, West Virginia University, Lifespan
- Responsible party
- Principal investigator, Michael Hassett, MD, Dana-Farber Cancer Institute
- Investigators
- Michael Hassett, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850912
- Sponsor's protocol ID
- 18-734
- Other IDs
- 1UM1CA233080-01
- Acronym
- SIMPRO
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2019
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research data set used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Publications
Siegel 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.
PubMed 28055103Cleeland 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.
PubMed 17951226Hofman 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.
PubMed 17573451Teunissen 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.
PubMed 17509812Temel 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.
PubMed 16512977Janjan 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.
PubMed 16580563Fleishman SB. Treatment of symptom clusters: pain, depression, and fatigue. J Natl Cancer Inst Monogr. 2004;(32):119-23. doi: 10.1093/jncimonographs/lgh028.
PubMed 15263052Hernandez-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.
PubMed 28657940Kenzik 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.
PubMed 25891437Hassett 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.
PubMed 35710449Hassett 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.
PubMed 34985914Paudel 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.
PubMed 38445744Paudel 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.
PubMed 38011613Ivatury 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.
PubMed 31452053Phillips 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.
PubMed 31463699
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice
- ClinicalTrials.gov ID
- NCT03850912
- Acronym / sponsor ID
- SIMPRO / 18-734
- Keywords
- Other Cancer, Digital health, Patient reported outcomes, Symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42,808 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), RTI International, Baptist Memorial Health Care Corporation, Dartmouth-Hitchcock Medical Center, MaineHealth, West Virginia University, Lifespan
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A multi-disciplinary team of investigators from 6 health systems have formed the Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) Research Center. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM. eSyM is the name of the platform the team will refine, integrate, implement and evaluate. eSyM addresses each of the 4 evidence gaps by:
- Implementing eSyM in cancer centers in small, rural or community-based systems.
- Integrating eSyM into the EHR (electronic health record) of the predominant vendor used nationwide.
- Leveraging evidence-based tools, patient engagement, and population management.
- Executing this work using the Consolidated Framework for Implementation Research across all phases to maximize the chances that eSyM and similar systems achieve their intended goals and decrease the morbidity of cancer treatment at a population level.
This project contains 5 activities:
- Obtain stakeholder feedback
- Build and deploy eSyM
- Pilot test eSyM
- Pragmatic stepped-wedge cluster randomized trial
- Integration of eSyM data to develop algorithms to estimate the risk of experiencing an outcome, including, but not limited to, ED usage and hospitalization among cancer patients
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- The primary study design is a hybrid effectiveness-implementation stepped-wedge cluster randomized trial involving several different research activities to assess outcomes.
| Arm | Type | Receives |
|---|---|---|
| Stakeholder Feedback (Control Period) | Other | Other: Stakeholder Survey (Control Period)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 |
| Stakeholder Feedback (Intervention Period) | Other | Other: Stakeholder Survey (Intervention Period)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 |
| SASS Questionnaire Participants (Control Period) | Other | Other: SASS QuestionnaireA 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. |
| SASS Questionnaire Participants (Intervention Period) | Other | Other: SASS QuestionnaireA 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. |
| Patient Qualitative Interviews | Other | Other: Qualitative InterviewA 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. |
| Stakeholder Qualitative Interviews | Other | Other: Qualitative InterviewA 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. |
| Pilot Testing | Other | Other: eSyMA subset of control patients at each site were selected to pilot test the eSyM intervention prior to trial start. |
| 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 | Other: eSyMThese patients (and/or proxy) were seen at a participating site after the trial rollout of eSyM and were exposed to the eSyM intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (1 listed)
- Participants not meeting the inclusion critera above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stakeholder Survey (Control Period)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. | Other | Stakeholder Feedback (Control Period) |
| Stakeholder Survey (Intervention Period)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. | Other | Stakeholder Feedback (Intervention Period) |
| Qualitative InterviewA small subset of patients and stakeholders were invited to take part in qualitative interviews after the eSyM trial rollout. | Other | Patient Qualitative Interviews, Stakeholder Qualitative Interviews |
| SASS QuestionnaireA 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. | Other | SASS Questionnaire Participants (Control Period), SASS Questionnaire Participants (Intervention Period) |
| eSyMThe electronic symptom management (eSyM) program is the EHR-integrated ePRO program being evaluated through this trial. | Other | Cluster Randomized Trial (Intervention Patients), Pilot Testing |
Primary outcome
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30
Time frame: 30 days
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.
13 secondary outcomes
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90
Time frame: 90 days
Admissions Event Occurrence Status at Day 30
Time frame: 30 Days
Admissions Event Occurrence Status at Day 90
Time frame: 90 Days
Difference in Fatigue PROMIS Scores Reported by Participants Before and After eSyM Exposure
Time frame: 30-90 days before and after eSyM go-live
Difference in Depression PROMIS Scores Reported by Participants Before and After eSyM Exposure
Time frame: 30-90 days before and after eSyM go-live
Difference in Anxiety PROMIS Scores Reported by Participants Before and After eSyM Exposure
Time frame: 30-90 days before and after eSyM go-live
Difference in Pain Interference PROMIS Scores Reported by Participants Before and After eSyM Exposure
Time frame: 30-90 days before and after eSyM go-live
Difference in Self-Efficacy PROMIS Scores Reported by Participants Before and After eSyM Exposure
Time frame: 30-90 days before and after eSyM go-live
Difference in Physical Function PROMIS Scores Reported by Participants Before and After eSyM Exposure
Time frame: 30-90 days before and after eSyM go-live
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)
Time frame: 30 days
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)
Time frame: 90 days
Admissions Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)
Time frame: 30 Days
Admissions Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28055103Siegel 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.
- Background: PubMed 17951226Cleeland 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.
- Background: PubMed 17573451Hofman 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.
- Background: PubMed 17509812Teunissen 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.
- Background: PubMed 16512977Temel 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.
- Background: PubMed 16580563Janjan 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.
- Background: PubMed 15263052Fleishman SB. Treatment of symptom clusters: pain, depression, and fatigue. J Natl Cancer Inst Monogr. 2004;(32):119-23. doi: 10.1093/jncimonographs/lgh028.
- Background: PubMed 28657940Hernandez-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.
- Background: PubMed 25891437Kenzik 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.
- Background: PubMed 35710449Hassett 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.
- Results publication: PubMed 34985914Hassett 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.
- Results publication: PubMed 38445744Paudel 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.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research data set used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hassett, MD principal investigator
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stakeholder Survey (Intervention Period), Qualitative Interview and SASS Questionnaire in people with Other Cancer and Gastrointestinal Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03850912, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.