Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial (E2C2)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    15000
  • sponsor
    Mayo Clinic
Updated on 4 October 2022
cancer
depression
anxiety
fatigue
sleep disturbances
solid tumor
depressed mood
sleep problem

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.

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

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.

Details
Condition Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Treatment questionnaire administration, quality-of-life assessment, Interview, E2C2 Collaborative Care
Clinical Study IdentifierNCT03892967
SponsorMayo Clinic
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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