Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

Status Active, not recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Neoplasms

Clinical Trial Details

NCT number	NCT03892967
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 28, 2019
Completion date	August 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06030427` - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT05660421` - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors	Phase 2
Suspended	`NCT04060849` - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY	Phase 1
Recruiting	`NCT06192875` - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed	`NCT04122118` - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor	N/A
Active, not recruiting	`NCT04940299` - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma	Phase 2
Active, not recruiting	`NCT03168737` - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients	Phase 1
Active, not recruiting	`NCT06062901` - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors	N/A
Active, not recruiting	`NCT02444741` - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer	Phase 1/Phase 2
Terminated	`NCT04081298` - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors	N/A
Active, not recruiting	`NCT04555837` - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer	Phase 1/Phase 2
Completed	`NCT04983901` - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN	Phase 2
Active, not recruiting	`NCT04602026` - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer	N/A
Recruiting	`NCT04871542` - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting	`NCT04592250` - Financial Toxicity in Cancer Patients
Recruiting	`NCT05112614` - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting	`NCT04296305` - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain	Phase 4
Recruiting	`NCT05873608` - Communication Issues in Patient and Provider Discussions of Immunotherapy	N/A
Recruiting	`NCT02464696` - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure	N/A