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EHR-Facilitated Case Management for Cancer (E2C2 Trial)

N/A
Waitlist Available
Led By Andrea L Cheville
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after last assessment
Awards & highlights

E2C2 Trial Summary

This trial is investigating whether collaborative case management for cancer patients can improve quality of life and symptom severity.

Who is the study for?
This trial is for cancer patients at Midwest Mayo Clinic sites experiencing severe symptoms like sleep issues, pain, anxiety, depression, fatigue (SPADE), and physical dysfunction. It aims to help manage these symptoms through case management.Check my eligibility
What is being tested?
The study tests an enhanced system using the electronic health record (EHR) to improve symptom control in cancer patients. Participants will undergo interviews, quality-of-life assessments, and questionnaires as part of the trial.See study design
What are the potential side effects?
Since this trial involves non-medical interventions such as interviews and questionnaires rather than drugs or medical procedures, traditional side effects are not expected.

E2C2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am being treated for cancer at a Midwest Mayo Clinic site.

E2C2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after last assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after last assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Physical function numerical rating scale (NRS) scores
Sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom scores
Secondary outcome measures
Adherence to cancer treatment
Anxiety
Average Pain Interference over the past week
+4 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Hypothyroidism
2%
Hemorrhoids
2%
Blurred vision
2%
Palpitations
2%
Acute kidney injury
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

E2C2 Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (interview)Experimental Treatment3 Interventions
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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,861,613 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,705,940 Total Patients Enrolled
Andrea L ChevillePrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
86,726 Total Patients Enrolled

Media Library

E2C2 Collaborative Care Clinical Trial Eligibility Overview. Trial Name: NCT03892967 — N/A
Blood Cancers Research Study Groups: Supportive care (interview)
Blood Cancers Clinical Trial 2023: E2C2 Collaborative Care Highlights & Side Effects. Trial Name: NCT03892967 — N/A
E2C2 Collaborative Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT03892967 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently accepting participants?

"Confirmed, the trial is actively enrolling patients. It was first advertised on March 28th 2019 and its most recent update was issued on August 23rd 2022 (per clinicaltrials.gov)."

Answered by AI

How many individuals is the trial attempting to recruit?

"Affirmative. According to clinicaltrials.gov, this medical research is still recruiting participants since its inception on March 28th 2019 and the most recent update on August 23rd 2022. The trial requires 15000 patients from a single site."

Answered by AI
~8728 spots leftby Mar 2025