Trial Outcomes & Findings for Symptom Management Implementation of Patient Reported Outcomes in Oncology (NCT NCT03850912)

Eligible patients and stakeholders were recruited at the six participating sites between Jan. 2018 and Feb. 2023. As this was a stepped wedge trial, each period has distinct enrollment. For the entire trial, grand total enrollment was 39,942 patients (21,112 control patients and 18,830 intervention patients).

Symptom Management Implementation of Patient Reported Outcomes in Oncology

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.

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.

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.

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 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 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 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 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 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 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).

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.

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.

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.

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.