Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 50,207
- Locations
- 2
- Primary Endpoint
- Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.
Time Frame: 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
Time Frame: 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 Outcomes
- 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))
- Adherence to Cancer Treatment(Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study))
- Change in Anxiety Score(Baseline to 46 months)
- Change in Depression Score(Baseline to 46 months)
- Change in Physical Function Score(Baseline to 46 months)
- Change in Average Pain Interference Over the Past Week(Baseline to 46 months)
- Number of Deceased Participants(Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study))