Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT03892967
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2019-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-06973 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA233033 | NIH | None | https://reporter.nih.gov/quic… | View |
| E2C2 | OTHER | Mayo Clinic Physical Medicine and Rehabilitation | View |