Symptom Management Implementation of Patient Reported Outcomes in Oncology (SIMPRO)

• ClinicalTrials.gov Identifier: NCT03850912
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2019
• Last Update Posted: April 30, 2024
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); RTI International; Baptist Memorial Health Care Corporation; Dartmouth-Hitchcock Medical Center; MaineHealth; West Virginia University; Lifespan
• Information provided by (Responsible Party): Michael Hassett, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: February 20, 2019
• First Posted Date: February 22, 2019
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: July 25, 2019
• Actual Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 25, 2024)

'Emergency Department - Treat and Release' (EDTR) Rate at 30-days [ 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 oncology) or the initiation date of a new intravenous chemo regimen (medical oncology). The investigators will evaluate the # of EDTR visits for patients using the eSyM app. 30-day EDTR rates are estimated to vary between 8% to 15% for the control group. The investigators hypothesize that EDTR rates will be 3-4% lower in the eSyM+ group. Control group rates were estimated based on EDTR rates derived from HCUP (Healthcare Cost and Utilization Project) data, institutional data and early phase analyses from CMMI's Oncology Care Model for Baptist Memorial, the only Oncology Care Model participant among our 6 sites.

Original Primary Outcome Measures (submitted: February 21, 2019)

'Emergency Department - Treat and Release' (EDTR) Rate at 30-days [ Time Frame: 30 days ]

The primary study outcome of the stepped wedge cluster RCT is the EDTR rate. This outcome will be defined in relation to the date of discharge from hospital (surgical oncology) or the initiation date of a new intravenous chemo regimen (medical oncology). We will evaluate the # of EDTR visits for patients using the eSyM app. 30-day EDTR rates are estimated to vary between 8% to 15% for the control group. We hypothesize that EDTR rates will be 3-4% lower in the eSyM+ group. Control group rates were estimated based on EDTR rates derived from HCUP data, institutional data and early phase analyses from CMMI's Oncology Care Model for Baptist Memorial, the only Oncology Care Model participant among our 6 sites.

Current Secondary Outcome Measures (submitted: April 25, 2024)

• Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage [ Time Frame: One time survey (30-60 days after surgery or first dose of chemo) ]
  Patients (both Surg Onc and Med Onc) from each of the 6 sites will be surveyed in the period before and after rollout according to the stepped wedge design schema. Assuming a 75% response rate, the investigators expect to survey 400 patients per site (2400 total) to obtain 300 (1800 total) responses split evenly between eSyM+ and eSyM- subjects. Additional survey participants can readily be identified if the 75% response rate is not achieved. Yost and Cella have reported minimally important difference (MID) ranges for five PROMIS (Patient-Reported Outcomes Measurement Information System) domains including fatigue, pain, depression, anxiety, and physical functioning217, 130 Cella recommends using 0.5 SD (Standard Deviation) as the MID for PROMIS scales218,219.
• Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's (Agency for Healthcare Research and Quality) CAHPS (Consumer Assessment of Healthcare Providers & Systems) Analysis Program [ Time Frame: One time survey (30-60 days after surgery or first dose of chemo) ]
  The investigators will use the AHRQ's CAHPS Analysis Program to compare scores for eSyM+ and eSyM-, adjusting for case mix. Table Aim 2d (in the protocol) shows differences in satisfaction scores the investigators can detect with 80% power. For example, with 360 patients (e.g., those who have GI surgery) the investigators have >80% power to detect effect size >0.44, a meaningful difference in CAHPS scores. Patients will complete a subset of the CAHPS Cancer Care Survey. Items assessed will include: cancer care delivery, patient experience, and patient satisfaction. Responses will be assessed through the following options: a) (Never, Sometimes, Usually, Always) b) (Yes, definitely, Yes, somewhat, No) c) 0-10.
• eSyM sustainability at the patient, clinic and health system level [ Time Frame: 1-year medical record abstraction ]
  The investigators will be evaluating patient adoption rates and clinician usage rates by analyzing EHR data based on eSyM utilization patterns. Appropriateness and acceptability will be ascertained using Weiner's IAM (Intervention Appropriateness Measure) and AIM (Acceptability of Intervention Measure) surveys (8-items total, less than 3 minutes to complete) which will be administered along with CAHPS surveys. Appropriateness and acceptability ratings will be defined based on the % of respondents who "agree" or "completely agree" with the survey items compared to the % who are neutral, disagree, or completely disagree and characterized using descriptive statistics.81
• Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year [ Time Frame: 1-year medical record abstraction ]
  The investigators will be using the EHR to evaluate the timing of first dose to the last dose of a specific chemotherapy regimen. The investigators expect that patients exposed to eSyM may be able to: 1) initiate adjuvant therapy sooner; 2) remain on their chemotherapy regimens for longer duration. These time intervals are straightforward to measure from EHR encounter and date fields. For medical oncology patients, the outcome is time from the first dose to the last dose of a specific regimen. The investigators will censor follow-up at 1 year. The investigators will use generalized linear mixed-effect models to compare treatment duration for eSyM+ vs. eSyM- patients. For surgical oncology patients, the denominator population consists of patients who receive any adjuvant chemotherapy within 6 postoperative months. Tumor registry stage distribution at our 6 sites indicates that this will be 202 patients per site or 1212 in total.
• Sustainability of ePRO symptom management within a health system [ Time Frame: 1-year medical record abstraction ]
  The investigators will evaluate sustainability at the patient, clinic and health system level using simple rates and proportions. To evaluate sustainability, the investigators will examine the consequences of withdrawing grant-funded nursing support for symptom management in the post-implementation period. The investigators will compare outcomes from Period 6 (study month 45-50, all sites eSyM+) and the post-Implementation (Post-I; study months 51-56). Sites are trained and empowered to manage eSyM autonomously without research study staff. Then, during post-implementation, dedicated nursing support to monitor eSyM is tapered in half the sites (see Figure C2). To examine whether backing off on the study support attenuates the effect, the investigators will perform difference in difference analysis.

Original Secondary Outcome Measures (submitted: February 21, 2019)

• Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage [ Time Frame: One time survey (30-60 days after surgery or first dose of chemo) ]
  Patients (both Surg Onc and Med Onc) from each of the 6 sites will be surveyed in the period before and after rollout according to the stepped wedge design schema. Assuming a 75% response rate, we expect to survey 400 patients per site (2400 total) to obtain 300 (1800 total) responses split evenly between eSyM+ and eSyM- subjects. Additional survey participants can readily be identified if the 75% response rate is not achieved. Yost and Cella have reported minimally important difference (MID) ranges for five PROMIS domains including fatigue, pain, depression, anxiety, and physical functioning217, 130 Cella recommends using 0.5 SD as the MID for PROMIS scales218,219.
• Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program [ Time Frame: One time survey (30-60 days after surgery or first dose of chemo) ]
  We will use the AHRQ's CAHPS Analysis Program to compare scores for eSyM+ and eSyM-, adjusting for case mix. Table Aim 2d (in the protocol) shows differences in satisfaction scores we can detect with 80% power. For example, with 360 patients (e.g., those who have GI surgery) we have >80% power to detect effect size >0.44, a meaningful difference in CAHPS scores.
• eSyM sustainability at the patient, clinic and health system level [ Time Frame: 1-year medical record abstraction ]
  We will be evaluating patient adoption rates and clinician usage rates by analyzing EHR data based on eSyM utilization patterns. Appropriateness and acceptability will be ascertained using Weiner's IAM and AIM surveys (8-items total, less than 3 minutes to complete) which will be administered along with CAHPS surveys. Appropriateness and acceptability ratings will be defined based on the % of respondents who "agree" or "completely agree" with the survey items compared to the % who are neutral, disagree, or completely disagree and characterized using descriptive statistics.81
• Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year [ Time Frame: 1-year medical record abstraction ]
  We will be using the EMR to evaluate the timing of first dose to the last dose of a specific chemotherapy regimen. We expect that patients exposed to eSyM may be able to: 1) initiate adjuvant therapy sooner; 2) remain on their chemotherapy regimens for longer duration. These time intervals are straightforward to measure from EHR encounter and date fields. For medical oncology patients, the outcome is time from the first dose to the last dose of a specific regimen. We will censor follow-up at 1 year. We will use generalized linear mixed-effect models to compare treatment duration for eSyM+ vs. eSyM- patients. For surgical oncology patients, the denominator population consists of patients who receive any adjuvant chemotherapy within 6 postoperative months. Tumor registry stage distribution at our 6 sites indicates that this will be 202 patients per site or 1212 in total.
• Sustainability of ePRO symptom management within a health system [ Time Frame: 1-year medical record abstraction ]
  We will evaluate sustainability at the patient, clinic and health system level using simple rates and proportions. To evaluate sustainability, we will examine the consequences of withdrawing grant-funded nursing support for symptom management in the post-implementation period. We will compare outcomes from Period 6 (study month 45-50, all sites eSyM+) and the post-Implementation (Post-I; study months 51-56). Sites are trained and empowered to manage eSyM autonomously without research study staff. Then, during post-implementation, dedicated nursing support to monitor eSyM is tapered in half the sites (see Figure C2). To examine whether backing off on the study support attenuates the effect, we will perform difference in difference analysis.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Symptom Management Implementation of Patient Reported Outcomes in Oncology
• Official Title: SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice
• 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

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:

1. Obtain stakeholder feedback
2. Build and deploy eSyM
3. Pilot test eSyM
4. Pragmatic stepped-wedge cluster randomized trial
5. 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Other Cancer
• Gastrointestinal Cancer
• Thoracic Cancer
• Gynecologic Cancer

Intervention

• Other: eSyM App Usage
  Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM
• Other: SASS Questionnaire
  A subset of eSyM+ and eSyM- 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 (see PROMIS, CAHPS, IAM/AIM question banks - Appendices C through G). The questionnaire will stop being administered once 1800 total surveys have been received.

Study Arms

• No Intervention: Activity 1: Stakeholder Feedback

  Obtain stakeholder feedback to inform eSyM finalization and implementation from:

  • patient advisory councils
  • health system leaders
  • clinicians
  • clinic support staff/administration
  • IT/Informatics
• No Intervention: Activity 2: eSym Build
  • Build and deploy eSyM
  • Finalize training materials based on findings from stakeholder engagement
• Experimental: Activity 3: Pilot Test eSyM App

  Pilot testing of the eSyM app will include:

  • Activity 3a (eSyM app usage by patients)
  • Activity 3b (User acceptability testing)
  • Activity 3c (Medical record abstraction)
  Intervention: Other: eSyM App Usage
• Experimental: Activity 4: eSyM+ Participants
  • These patients (and/or proxy) will report their symptoms in eSyM
  • A subset of these patients will be asked to complete a research questionnaire called the "SASS (Self-Efficacy, Attainment of informational needs, Symptom Burden, and Satisfaction with care) Questionnaire (eSyM+ version or eSyM-Non-Responder version)"
  • A medical record abstraction will be completed for all eSyM+ patients
  Interventions:

  • Other: eSyM App Usage
  • Other: SASS Questionnaire
• Experimental: Activity 4: eSyM- Participants
  • These patients (and/or proxy) will NOT report their symptoms in eSyM
  • A subset of these patients will be asked to complete a research questionnaire called the "SASS Questionnaire (eSyM- version)"
  • A medical record abstraction will be completed for all eSyM- patients
  Intervention: Other: SASS Questionnaire

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 20, 2023): 25000
• Original Estimated Enrollment (submitted: February 21, 2019): 18000
• Estimated Study Completion Date: September 30, 2024
• Actual Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Activity 1 Population:

• Age ≥ 18 years
• The potential stakeholders are: patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff

Activity 3 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.

Activity 4 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03850912
• Other Study ID Numbers: 18-734; 1UM1CA233080-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (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

• Current Responsible Party: Michael Hassett, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Deborah Schrag, MD, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Michael Hassett, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: April 2024