Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial

This early phase I trial investigates enhanced, electronic health record (EHR)-facilitated cancer system control. Cancer and its treatment are often associated with severe, disabling symptoms that have been causally linked to diminished survival, increased healthcare utilization, degraded quality of life, unemployment, and non-adherence to recommended cancer treatments. Collaborative case management for control of moderate or worse sleep disturbance, pain, anxiety, depression, fatigue (SPADE symptoms), and physical dysfunction among cancer survivors and patients with cancer may improve quality of life, symptom severity, and adherence to cancer treatment, and may also reduce need for acute care.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Interview

Detailed Description

PRIMARY OBJECTIVES:

I. Conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that a symptom control-focused enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) intervention will significantly reduce sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom and physical dysfunction scores, reduce unplanned hospitalizations and emergency department visits, improve adherence to cancer therapies, and improve self-reported quality of life.

II. Evaluate the hypothesis that use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 system will result in improvements in implementation and clinical outcomes.

III. Conduct a mixed methods evaluation to detect, understand and reduce disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer.

OUTLINE:

The first Primary Objective involves a stepped wedge enrollment into the study intervention. Involvement is based off the patients' responses to the pain questionnaire (low pain = no involvement, moderate pain = offer of patient education materials, severe pain = involvement of a Symptom Care Manager). Symptom Care Managers will work with interested patients who endorse high pain to help address and manage their pain. The third objective involves a subset of patients included in the E2C2 who are offered to participate in a one-time interview lasting 30-45 minutes. Providers and stakeholders also will be invited to participate in an interview lasting 15-30 minutes.

• Study Type: Interventional
• Enrollment (Actual): 50207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site or for a solid tumor at Mayo Clinic Rochester

Exclusion Criteria:

• No Minors (under age 18) will receive the questionnaires but no further exclusions can be made based on the standard of care for questionnaire assignment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (interview); Patients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Interview; Participate in interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.	Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.	Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
Physical Function Numerical Rating Scale (NRS) Scores	Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of >=4/10 modeled jointly as a co-primary outcome.	Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Score	Measured PROMIS-CAT T-scores up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.	Baseline to 46 months
Change in Depression Score	Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.	Baseline to 46 months
Change in Average Pain Interference Over the Past Week	Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.	Baseline to 46 months
Change in Physical Function Score	Measured PROMIS-CAT up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a better outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.	Baseline to 46 months
Health Care Utilization	ER visits, hospitalizations, and ICU admissions	Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)
Adherence to Cancer Treatment	Number of doses of docetaxel and cyclophosphamide administered.	Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)
Number of Deceased Participants	Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index	Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andrea L Cheville, Mayo Clinic in Rochester

Publications and helpful links

General Publications

• Kuharic M, Merle JL, Cella D, Mitchell SA, DiMartino L, Ridgeway JL, Dizon DS, Paudel R, Austin JD, Wong SL, Flores AM, Cheville AL, Smith JD; IMPACT Consortium. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning. Implement Sci Commun. 2025 Jun 16;6(1):72. doi: 10.1186/s43058-025-00756-3.
• Finney Rutten LJ, Ruddy KJ, Chlan LL, Griffin JM, Herrin J, Leppin AL, Pachman DR, Ridgeway JL, Rahman PA, Storlie CB, Wilson PM, Cheville AL. Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2). Trials. 2020 Jun 5;21(1):480. doi: 10.1186/s13063-020-04335-w.
• Minteer SA, Ridgeway JL, Pachman DR, Austin JD, Griffin JM, Ruddy KJ, Cheville AL. Barriers and facilitators to using practice facilitators to implement a remote cancer symptom management intervention: a mixed methods study. BMC Health Serv Res. 2025 Sep 3;25(1):1189. doi: 10.1186/s12913-025-13378-1.
• Austin JD, Finney Rutten LJ, Fischer K, Ridgeway J, Minteer S, Griffin JM, Pachman DR, Ruddy KJ, Cheville A. Advancing Care Team Adoption of Electronic Health Record Systems for Cancer Symptom Management: Findings From a Hybrid Type II, Cluster-Randomized, Stepped-Wedge Trial. JCO Oncol Pract. 2025 Feb;21(2):209-217. doi: 10.1200/OP.24.00280. Epub 2024 Aug 6.
• Ridgeway JL, Cheville AL, Fischer KJ, Tesch NK, Austin JD, Minteer SA, Pachman DR, Chlan LL, Ruddy KJ, Griffin JM. Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention. Contemp Clin Trials Commun. 2024 Feb 9;38:101269. doi: 10.1016/j.conctc.2024.101269. eCollection 2024 Apr.
• Kroenke K, Lam V, Ruddy KJ, Pachman DR, Herrin J, Rahman PA, Griffin JM, Cheville AL. Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer. J Pain Symptom Manage. 2023 May;65(5):367-377. doi: 10.1016/j.jpainsymman.2023.01.020. Epub 2023 Feb 2.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: 18-007779 (Mayo Clinic in Rochester); P30CA015083 (U.S. NIH Grant/Contract); NCI-2020-06973 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); UM1CA233033 (U.S. NIH Grant/Contract); E2C2 (Other Identifier: Mayo Clinic Physical Medicine and Rehabilitation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No