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

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ClinicalTrials.gov Identifier: NCT03892967
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrea Cheville, Mayo Clinic

Brief Summary:
The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) pragmatic clinical trial will test the population-level implementation of validated approaches to detect and effectively manage sleep disturbance, pain, anxiety, depression, energy deficit/fatigue, and functional decline among patients with all types and stages of cancer using a cluster-randomized, stepped wedge design.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Pain Anxiety Depression Fatigue Other: E2C2 Collaborative Care Not Applicable

Detailed Description:
The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial tests whether systematically assessing patient reported outcomes for sleep disturbance, pain, anxiety, depression, and fatigue among patients with solid and liquid malignancies and using these data to increase the frequency of guideline-concordant care by: 1) reporting these data to their clinical teams, 2) providing patients with needs-matched symptom self-management education, and 3) suggesting evidence-based symptom management strategies to their care teams improves patients' quality of life, symptoms, and adherence to cancer treatment, while reducing their unplanned use of healthcare resources. This population-based trial uses a cluster-randomized, stepped wedge design to evaluate the full population of patients managed within Mayo Clinic Midwest medical oncology practices irrespective of cancer type or stage.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: We will conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that the E2C2 intervention will significantly reduce SPADE symptom scores, reduce unplanned hospitalizations and emergency department visits, increase adherence to cancer therapies, improve physical function, and enhance quality of life (QoL).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Fatigue

Arm Intervention/treatment
Experimental: E2C2 Collaborative Care
A guideline-informed intervention that combines low touch automated provision of symptom self-management education, coupled with EHR clinical decision support, for moderate symptoms with conventional, high-touch, collaborative care provided by a nurse-physician team for more intense symptoms. Additionally, the E2C2 intervention will increase the frequency of symptom and function screening. Prior to E2C2 intervention initiation, patients will only be assessed in association with a physician or allied health provider encounter. They will not be assessed when seen for nurse-only visits, or for systemic treatments. Following E2C2 intervention activation, they will be assessed every other week which will require remote, portal-based assessment for patients who lack clinic appointments.
Other: E2C2 Collaborative Care
Stepped collaborative care to address moderate and severe levels of sleep disturbance, pain, anxiety, depression, fatigue, and functional decline.
Other Name: Enhanced EHR-facilitated Cancer Symptom Control




Primary Outcome Measures :
  1. Change in sleep disturbance [ Time Frame: Baseline, every two weeks for up to 3 years ]
    The Brief Symptom and Function Screen numerical rating scale will be used to measure self-reported sleep disturbance at the time of administration. The single item scale is scored 0 (no sleep disturbance) to 10 (as bad as you can imagine). Total scores range from 0 to 10.

  2. Change in pain interference [ Time Frame: Baseline, every two weeks for up to 3 years ]
    The Brief Symptom and Function Screen numerical rating scale will be used to measure self-reported pain interference at the time of administration. The single item scale is scored 0 (no pain interference) to 10 (as bad as you can imagine). Total scores range from 0 to 10.

  3. Change in anxiety [ Time Frame: Baseline, every two weeks for up to 3 years ]
    The Brief Symptom and Function Screen numerical rating scale will be used to measure self-reported anxiety at the time of administration. The single item scale is scored 0 (no anxiety) to 10 (as bad as you can imagine). Total scores range from 0 to 10.

  4. Change in emotional distress [ Time Frame: Baseline, every two weeks for up to 3 years ]
    The Brief Symptom and Function Screen numerical rating scale will be used to measure self-reported emotional distress at the time of administration. The single item scale is scored 0 (no emotional distress) to 10 (as bad as you can imagine). Total scores range from 0 to 10.

  5. Change in physical function [ Time Frame: Baseline, every two weeks for up to 3 years ]
    The Brief Symptom and Function Screen numerical rating scale will be used to measure self-reported physical function limitations at the time of administration. The single item scale is scored 0 (no physical function limitations) to 10 (as bad as you can imagine). Total scores range from 0 to 10.

  6. Change in fatigue [ Time Frame: Baseline, every two weeks for up to 3 years ]
    The Brief Symptom and Function Screen numerical rating scale will be used to measure self-reported fatigue at the time of administration. The single item scale is scored 0 (no fatigue) to 10 (as bad as you can imagine). Total scores range from 0 to 10.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing treatment, or have undergone treatment, for cancer at a Mayo Clinic Midwest medical oncology clinic.

Exclusion Criteria:

  • Lack of English Fluency
  • Membership in a vulnerable population - Prisoner
  • Membership in a vulnerable population - Mentally handicapped
  • Membership in a vulnerable population - Axis I psychiatric condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892967


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amanda M Nelson    507-422-6252    nelson.amanda2@mayo.edu   
Principal Investigator: Andrea L Cheville         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andrea L Cheville Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Andrea Cheville, Mayo Clinic:

Additional Information:
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Responsible Party: Andrea Cheville, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03892967     History of Changes
Other Study ID Numbers: 18-007779
1UM1CA233033-01 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The PLANET portal was designed to provide easy access to resources that can facilitate the transfer of evidence-based research findings into practice. The site is public access and supports storage and downloading of all file types; all Adobe and Microsoft, multimedia, and compressed files. The resource is designed to help clinicians, planners, program staff, and researchers to design, implement and evaluate evidence-based cancer control programs, including symptom management. Specifically, Cancer Control P.L.A.N.E.T was expressly developed to allow for free accessing and downloading of evidence-based programs and products.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data availability is estimated to be June 30, 2025 after review by the National Cancer Institute.
Access Criteria: All material will have undergone stringent usability and cognitive testing, as well as being vetted by the other IMPACT Centers before being made publically available via the National Cancer Institute's Cancer Control Plan, Link, Act, Network with Evidence-based Tools (P.L.A.N.E.T) portal.
URL: https://cancercontrolplanet.cancer.gov/about.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrea Cheville, Mayo Clinic:
SPADE
Cancer Control
Sleep Disturbance
Electronic Health Record
Pain
Anxiety
Depression
Fatigue

Additional relevant MeSH terms:
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Depression
Fatigue
Dyssomnias
Sleep Wake Disorders
Parasomnias
Behavioral Symptoms
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Neurologic Manifestations