Symptom Management Implementation of Patient Reported Outcomes in Oncology

Not Applicable

Completed

Conditions: Gynecologic Cancer
Gastrointestinal Cancer
Other Cancer
Thoracic Cancer

Registration Number: NCT03850912

Lead Sponsor: Dana-Farber Cancer Institute

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42808

Inclusion Criteria

Stakeholder Feedback and Stakeholder Qualitative Interviews Population:

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

Cluster Randomized Trial, Patient QualitativeInterviews, Pilot Testing & SASS Questionnaire Population:

Age ≥ 18 years
Priority population will be patients who meet one of the following:
- Suspected thoracic cancer [lung or bronchus] AND is inpatient following thoracic surgery.
- Suspected gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND is inpatient following gastrointestinal surgery.
- Suspected gynecologic cancer [ovary, uterus, or cervix] AND is inpatient following gynecologic surgery.
- Diagnosis of thoracic cancer [lung or bronchus] AND scheduled to start a new treatment plan for thoracic cancer.
- Diagnosis of gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND scheduled to start a new treatment plan for gastrointestinal cancer.
- Diagnosis of gynecologic cancer [ovary, uterus, or cervix] AND scheduled to start a new treatment plan for gynecologic cancer.
Total population allowed to use eSyM:
- Any patient at any participating site.

Exclusion Criteria

- Participants not meeting the inclusion critera above.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30	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.

Secondary Outcome Measures

Name	Time	Method
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90	90 days	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.
Admissions Event Occurrence Status at Day 30	30 Days	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.
Admissions Event Occurrence Status at Day 90	90 Days	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.
Difference in Fatigue PROMIS Scores Reported by Participants Before and After eSyM Exposure	30-90 days before and after eSyM go-live	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).
Difference in Depression PROMIS Scores Reported by Participants Before and After eSyM Exposure	30-90 days before and after eSyM go-live	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.
Difference in Anxiety PROMIS Scores Reported by Participants Before and After eSyM Exposure	30-90 days before and after eSyM go-live	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.
Difference in Pain Interference PROMIS Scores Reported by Participants Before and After eSyM Exposure	30-90 days before and after eSyM go-live	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.
Difference in Self-Efficacy PROMIS Scores Reported by Participants Before and After eSyM Exposure	30-90 days before and after eSyM go-live	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.
Difference in Physical Function PROMIS Scores Reported by Participants Before and After eSyM Exposure	30-90 days before and after eSyM go-live	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).
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)	30 days	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.
Emergency Department Treat/Release [EDTR] Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)	90 days	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.
Admissions Event Occurrence Status at Day 30 (Comparing eSyM Intervention Responders Versus Non-Responders)	30 Days	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.
Admissions Event Occurrence Status at Day 90 (Comparing eSyM Intervention Responders Versus Non-Responders)	90 Days	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.

Trial Locations

Locations (6): Brown University Health (formerly Lifespan Cancer Institute)
🇺🇸
Providence, Rhode Island, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Baptist Memoiral HealthCare
🇺🇸
Memphis, Tennessee, United States
West Virginia University Medical Center
🇺🇸
Morgantown, West Virginia, United States
Brown University Health (formerly Lifespan Cancer Institute)
🇺🇸Providence, Rhode Island, United States