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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

ONE TEAM Trial 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.Check my eligibility
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.See study design
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.

ONE TEAM Trial 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.

ONE TEAM Trial 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

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

ONE TEAM 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
2,360 Previous Clinical Trials
3,419,530 Total Patients Enrolled

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT04258813 — N/A
Non-Small Cell Lung Cancer Research Study Groups: iGuide Intervention, Control
Non-Small Cell Lung Cancer Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT04258813 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258813 — N/A

Frequently Asked Questions

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

Do you accept individuals aged 35 and older into this research project?

"In compliance with the stipulated eligibility criteria, individuals must be between 18 and 79 years old to participate in this clinical trial."

Answered by AI

What is the size of the patient cohort participating in this experiment?

"Affirmative. According to clinicaltrials.gov, the medical trial posted on June 14th 2021 is actively recruiting candidates. 800 patients are required from a single centre for this study which was most recently updated on May 20th 2022."

Answered by AI

What are the objectives of this experiment?

"This 18 month clinical trial aims to assess the HEDIS quality measure of diabetes management. Secondary objectives include evaluating patient activation, provider-reported care coordination, and financial burden. To evaluate patient activation, researchers will use the Patient Activation Measure (PAM), which is a 13-item test that places patients into four levels based on their knowledge, skills, and confidence in managing health conditions. Provider-reported care coordination will be evaluated using two separate surveys: The Coordination of Specialty Care - Specialist Survey (13 items) and the Coordination of Specialty Care - Primary Care Survey (24 items). Finally, financial burden or '"

Answered by AI

Does my profile satisfy the criteria necessary to join this research endeavor?

"This clinical trial specifically seeks 800 individuals with hypertension aged between 18 and 79. For eligibility, participants must have had a physical check-up within the past 12 months, alongwith having at least one of three comorbid cardiovascular diseases (hypertension, diabetes or hypercholesterolemia). In addition to these applicants, 2800-3000 patients will be selected from Duke Cancer Registry who are over 65 years old and possess any of the aforementioned CVDs. These selected retrospective cohorts will then proceed on cancer surgery for solid tumors such as breast, prostate and colorectal cancers before December 31st 2019."

Answered by AI

Are there any enrollment opportunities for this experiment currently available?

"Exactly, the data accessible through clinicaltrials.gov portrays this medical trial as actively seeking volunteers. It was initially published on June 14th 2021 and has been recently amended on May 20th 2022. 800 participants are in need of recruitment from a single location."

Answered by AI
~152 spots leftby Dec 2024