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NCT03892967 Clinical Trial

Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03892967
Other study ID # 18-007779
Secondary ID NCI-2020-06973P3
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 28, 2019
Est. completion date August 2024

Study information
Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 52371
Est. completion date August 2024
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Interview
Participate in interview
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom scores Measured by 11-point Numeric Rating Scale (NRS) every 30 days, up to 12 Months after last assessment Up to 12 Months after last assessment
Primary Physical function numerical rating scale (NRS) scores Measured by 11-point Numeric Rating Scale (NRS) every 30 days, up to 12 Months after last assessment Up to 12 Months after last assessment
Secondary Anxiety Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment Up to 12 Months after last assessment
Secondary Depression Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment Up to 12 Months after last assessment
Secondary Average Pain Interference over the past week Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment Up to 12 Months after last assessment
Secondary Physical function Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment Up to 12 Months after last assessment
Secondary Health care utilization ER visits & hospitalizations Up to 12 Months after last assessment
Secondary Adherence to cancer treatment Examine frequency of missed imaging, medical oncology clinic visits, and chemotherapy appointments and capture any unplanned hiatuses in cancer treatment or dose reductions Up to 12 Months after last assessment
Secondary Vital Status Vital status as determined by Accurint record search across multiple sources, including the Social Security Death Index Up to 12 Months after last assessment/until 4 months after completion of intervention delivery
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