Clinical trial NCT03892967: Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial
Official title: Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-27
Enrollment: 52371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom scores
timeFrame: Up to 12 Months after last assessment
measure: Physical function numerical rating scale (NRS) scores
timeFrame: Up to 12 Months after last assessment
Secondary outcomes:
measure: Anxiety
timeFrame: Up to 12 Months after last assessment
measure: Depression
timeFrame: Up to 12 Months after last assessment
measure: Average Pain Interference over the past week
timeFrame: Up to 12 Months after last assessment
measure: Physical function
timeFrame: Up to 12 Months after last assessment
measure: Health care utilization
timeFrame: Up to 12 Months after last assessment
measure: Adherence to cancer treatment
timeFrame: Up to 12 Months after last assessment
measure: Vital Status
timeFrame: Up to 12 Months after last assessment/until 4 months after completion of intervention delivery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Andrea L Cheville
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finney Rutten LJ, Ruddy KJ, Chlan LL, Griffin JM, Herrin J, Leppin AL, Pachman DR, Ridgeway JL, Rahman PA, Storlie CB, Wilson PM, Cheville AL. Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2). Trials. 2020 Jun 5;21(1):480. doi: 10.1186/s13063-020-04335-w.