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TEAM-based Care for Cancer (ONE TEAM Trial)

N/A
Recruiting
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic Lymphocytic Leukemia or small lymphocytic lymphoma on first or second line treatment
Diagnosed with Stage I-III breast, colorectal, endometrial, head/neck, and non-small cell lung cancer, or Stage I-IV prostate cancer
Must not have
Uterine sarcomas
Patients who are coming to Duke for surgery only and not planning to return
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new way of managing care for cancer patients with comorbidities. 800 patients will be randomly assigned to either usual care or care that includes their primary care physician as an active member of their cancer care team. The goal is to improve chronic disease management and communication among cancer survivors.

Who is the study for?
Adults aged 18-79 with Stage I-III breast, colorectal, endometrial, head/neck, non-small cell lung cancer or Stage I-IV prostate cancer. They must have visited their PCP in the last year and have at least one CVD comorbidity (hypertension, diabetes, hypercholesterolemia). Exclusions include severe kidney disease (eGFR <30), certain heart conditions (Stage III-IV heart failure or recent myocardial infarction), language barriers, and specific tumor types.
What is being tested?
The ONE TEAM Study tests a new care approach for cancer survivors with cardiovascular diseases. It involves two interventions: iGuide 2 Intervention (tailored/targeted) and iGuide Intervention (self-guided), compared to standard care. The study aims to improve chronic disease management by involving primary care physicians more actively in the cancer treatment team.
What are the potential side effects?
Since this trial focuses on care coordination rather than medication or surgical intervention, traditional side effects are not applicable. However, participants may experience varying levels of satisfaction with healthcare services and differences in health outcomes based on the intervention received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on my first or second treatment for CLL or SLL.
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I have been diagnosed with early to mid-stage cancer in specific areas or any stage of prostate cancer.
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I am between 18 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with uterine sarcoma.
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I am having surgery at Duke but won't return for follow-up.
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My heart is weak, functioning below 30% efficiency.
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I have had a heart attack in the last 2 years.
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I have had surgery to remove lymph nodes under both arms.
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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diversity supplement : 90-day postoperative cardiovascular complications
HEDIS quality measure of management hypertension
HEDIS quality measure of management of diabetes
+3 more
Secondary study objectives
Clinical laboratory values
Financial burden
Medication adherence defined through patient self-report
+3 more
Other study objectives
PCP-reported care coordination
Risk index for cardiovascular complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: iGuide InterventionExperimental Treatment2 Interventions
40 PCP clinics; 400 patients
Group II: ControlExperimental Treatment1 Intervention
40 PCP clinics; 400 patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15780

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,968,120 Total Patients Enrolled
13 Trials studying Diabetes
34,760 Patients Enrolled for Diabetes

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT04258813 — N/A
Diabetes Research Study Groups: iGuide Intervention, Control
Diabetes Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT04258813 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258813 — N/A
~0 spots leftby Dec 2024
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