Clinical trial · Interventional
Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial
Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial
NCT03892967CI-TRIAL-00096381completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interview | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (interview)
- description
- 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.
- interventionNames
- Other: Interview
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
- timeFrame
- Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDFinney 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. PMID 32503661
- DERIVEDCheville AL, Herrin J, Pachman DR, Grzegorczyk V, Kroenke K, Ridgeway JL, Minteer SA, Austin JD, Griffin JM, Chlan L, Tofthagen C, Mitchell SA, Smith A, Ruddy KJ. Electronic health record-facilitated symptom surveillance and collaborative care intervention in oncology (E2C2): a cluster-randomised, population-level, stepped-wedge, pragmatic trial. Lancet Oncol. 2026 Jan;27(1):125-136. doi: 10.1016/S1470-2045(25)00526-1. Epub 2025 Dec 1. PMID 41344348
- DERIVEDMinteer 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. PMID 40903741
- DERIVEDKuharic 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. PMID 40524282
- DERIVEDAustin 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. PMID 39106420
- DERIVEDRidgeway 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.