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

Primary Purpose

Other Cancer, Gastrointestinal Cancer, Thoracic Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

eSyM App Usage

SASS Questionnaire

About this trial

This is an interventional health services research trial for Other Cancer focused on measuring Other Cancer, Digital health, Patient reported outcomes, Symptom management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Maine Medical Center
Dana Farber Cancer Institute
Dartmouth-Hitchcock Medical Center
Lifespan
Baptist Memoiral HealthCare
West Virginia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Arm Label

Activity 1: Stakeholder Feedback

Activity 2: eSym Build

Activity 3: Pilot Test eSyM App

Activity 4: eSyM+ Participants

Activity 4: eSyM- Participants

Arm Description

Obtain stakeholder feedback to inform eSyM finalization and implementation from: patient advisory councils health system leaders clinicians clinic support staff/administration IT/Informatics

Build and deploy eSyM Finalize training materials based on findings from stakeholder engagement

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)

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 Questionnaire (eSyM+ version or eSyM-Non-Responder version)" A medical record abstraction will be completed for ALL eSyM+ patients

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

Outcomes

Primary Outcome Measures

'Emergency Department - Treat and Release' (EDTR) Rate at 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). 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 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.

Secondary Outcome Measures

Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage

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 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

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

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 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

The investigators will be using the EMR 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

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.

Full Information

NCT ID

NCT03850912

First Posted

February 20, 2019

Last Updated

June 20, 2023

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

1. Study Identification

Unique Protocol Identification Number

NCT03850912

Brief Title

Symptom Management Implementation of Patient Reported Outcomes in Oncology

Acronym

SIMPRO

Official Title

SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 25, 2019 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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 4 activities: Obtain stakeholder feedback Build and deploy eSyM Pilot test eSyM Pragmatic stepped-wedge cluster randomized trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Cancer, Gastrointestinal Cancer, Thoracic Cancer, Gynecologic Cancer

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Activity 1: Stakeholder Feedback

Arm Type

No Intervention

Arm Description

Obtain stakeholder feedback to inform eSyM finalization and implementation from: patient advisory councils health system leaders clinicians clinic support staff/administration IT/Informatics

Arm Title

Activity 2: eSym Build

Arm Type

No Intervention

Arm Description

Build and deploy eSyM Finalize training materials based on findings from stakeholder engagement

Arm Title

Activity 3: Pilot Test eSyM App

Arm Type

Experimental

Arm Description

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)

Arm Title

Activity 4: eSyM+ Participants

Arm Type

Experimental

Arm Description

Arm Title

Activity 4: eSyM- Participants

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

eSyM App Usage

Intervention Description

Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM

Intervention Type

Other

Intervention Name(s)

SASS Questionnaire

Intervention Description

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.

Primary Outcome Measure Information:

Title

'Emergency Department - Treat and Release' (EDTR) Rate at 30-days

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage

Description

Time Frame

One time survey (30-60 days after surgery or first dose of chemo)

Title

Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program

Description

Time Frame

One time survey (30-60 days after surgery or first dose of chemo)

Title

eSyM sustainability at the patient, clinic and health system level

Description

Time Frame

1-year medical record abstraction

Title

Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year

Description

Time Frame

1-year medical record abstraction

Title

Sustainability of ePRO symptom management within a health system

Description

Time Frame

1-year medical record abstraction

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Hassett, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maine Medical Center

City

Portland

State/Province

Maine

ZIP/Postal Code

04101

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Lifespan

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

Facility Name

Baptist Memoiral HealthCare

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

West Virginia University Medical Center

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

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Symptom Management Implementation of Patient Reported Outcomes in Oncology

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