Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

Not Applicable

Completed

Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm

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:

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50207

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

Primary Outcome Measures

Name	Time	Method
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.	Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)	Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.
Physical Function Numerical Rating Scale (NRS) Scores	Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)	Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes. Changes in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of \>=4/10 modeled jointly as a co-primary outcome.

Secondary Outcome Measures

Name	Time	Method
Health Care Utilization	Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)	ER visits, hospitalizations, and ICU admissions
Adherence to Cancer Treatment	Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)	Number of doses of docetaxel and cyclophosphamide administered.
Change in Anxiety Score	Baseline to 46 months	Measured PROMIS-CAT T-scores up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Change in Depression Score	Baseline to 46 months	Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Change in Physical Function Score	Baseline to 46 months	Measured PROMIS-CAT up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a better outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Change in Average Pain Interference Over the Past Week	Baseline to 46 months	Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.
Number of Deceased Participants	Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)	Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index