Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial (E2C2)
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- STATUS
- Recruiting
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- End date
- Aug 31, 2023
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- participants needed
- 15000
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- sponsor
- Mayo Clinic
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.
Details
| Condition | Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm |
|---|---|
| Treatment | questionnaire administration, quality-of-life assessment, Interview, E2C2 Collaborative Care |
| Clinical Study Identifier | NCT03892967 |
| Sponsor | Mayo Clinic |
| Last Modified on | 4 October 2022 |
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