Study 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.
Eligible Conditions
- High Blood Pressure
- Cancer
- Endometrial Cancer
- Liver Cancer
- Renal Cell Cancer
- Ovarian Cancer
- Colorectal Cancer
- Breast Cancer
- Diabetes
- Pancreatic Cancer
- Prostate Cancer
- Esophageal Cancer
- High Cholesterol
- Head and Neck Cancer
- Non-Small Cell Lung Cancer
- Cardiovascular Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 6 Secondary · Reporting Duration: 18 months
12 months
PCP-reported care coordination
18 months
Clinical laboratory values
Financial burden
HEDIS quality measure of management hypertension
HEDIS quality measure of management of diabetes
HEDIS quality measure of management of statin use
Medication adherence
Medication adherence defined through patient self-report
Patient activation
Patient-Centered Communication in Cancer Care
Patient-reported care coordination
Provider-reported care coordination
90 days
Diversity supplement : 90-day postoperative cardiovascular complications
Risk index for cardiovascular complications
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
iGuide Intervention
1 of 2
Control
1 of 2
Experimental Treatment
800 Total Participants · 2 Treatment Groups
Primary Treatment: iGuide Intervention (Self-guided) · No Placebo Group · N/A
iGuide InterventionExperimental Group · 2 Interventions: iGuide Intervention (Self-guided), iGuide 2 Intervention (Tailored/Targeted) · Intervention Types: Behavioral, Behavioral
Control
Behavioral
Experimental Group · 1 Intervention: Control · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15680
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,173 Previous Clinical Trials
3,199,127 Total Patients Enrolled
Eligibility Criteria
Age 18 - 79 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a physician who has provided care to ≥1 older adult patient who has undergone cancer surgery within a 12-month period at Duarte University Health System.
You have at least one of three CVD comorbidities (hypertension, diabetes, or hypercholesterolemia) - based upon whether the patient is currently on a medication for the comorbidity at time of recruitment.
This study is evaluating whether older adults with cancer who have CVD are more likely to have complications after surgery.
References
- Zullig, Leah L., Mohammad Shahsahebi, Benjamin Neely, Terry Hyslop, Renee A. V. Avecilla, Brittany M. Griffin, Kacey Clayton-Stiglbauer, et al.. 2021. “Low-touch, Team-based Care for Co-morbidity Management in Cancer Patients: The ONE TEAM Randomized Controlled Trial”. BMC Family Practice. Springer Science and Business Media LLC. doi:10.1186/s12875-021-01569-8.
- 2021. "Onco-primary Care Networking to Support TEAM-based Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258813.
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Conditions
Cancer Related
Treatments