Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

Not Applicable

Active, not recruiting

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03892967
• Lead Sponsor: Mayo Clinic

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:

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.

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-03-28
• Primary Completion: 2023-01-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52371

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (interview)	Quality-of-Life Assessment	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.
Supportive care (interview)	Questionnaire Administration	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.
Supportive care (interview)	Interview	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.

Primary Outcome Measures

Name	Time	Method
Sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom scores	Up to 12 Months after last assessment	Measured by 11-point Numeric Rating Scale (NRS) every 30 days, up to 12 Months after last assessment
Physical function numerical rating scale (NRS) scores	Up to 12 Months after last assessment	Measured by 11-point Numeric Rating Scale (NRS) every 30 days, up to 12 Months after last assessment

Secondary Outcome Measures

Name	Time	Method
Average Pain Interference over the past week	Up to 12 Months after last assessment	Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment
Depression	Up to 12 Months after last assessment	Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment
Physical function	Up to 12 Months after last assessment	Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment
Vital Status	Up to 12 Months after last assessment/until 4 months after completion of intervention delivery	Vital status as determined by Accurint record search across multiple sources, including the Social Security Death Index
Anxiety	Up to 12 Months after last assessment	Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment
Health care utilization	Up to 12 Months after last assessment	ER visits \& hospitalizations
Adherence to cancer treatment	Up to 12 Months after last assessment	Examine frequency of missed imaging, medical oncology clinic visits, and chemotherapy appointments and capture any unplanned hiatuses in cancer treatment or dose reductions

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States