Onco-primary Care Networking to Support TEAM-based Care

Running, not enrolling · Not applicable

Conditions studied: Blood Pressure, Hypertension, Cancer, Cancer, Breast, Cancer of Prostate, Cancer Colorectal, Cancer, Endometrial, Cancer of Head and Neck, Non Small Cell Lung Cancer, CVD - Cardiovascular Disease, Diabetes Mellitus, Hypercholesterolemia, Diabetes, Cancer of Esophagus, Cancer of Liver, Cancer, Renal Cell, Cancer of Pancreas, Cancer Ovaries

In brief

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

Key facts

Study ID: NCT04258813
Run by: Duke University
People needed: 313
Starts: 2021-06-14
Expected to finish: 2026-07-31
Last updated by the study team: 2026-02-20

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

A total of 800 individuals who fall under the following criteria will be enrolled:
Diagnosed with -
Stage I-III breast [female], colorectal, endometrial (carcinomas), head/neck [H/N] and non-small cell lung cancer [NSCLC]
Stage I-IV prostate cancer
Organ transplant recipients are not excluded as long as kidney function is within eligible range
Chronic Lymphocytic Leukemia or small lymphocytic lymphoma on first or second line treatment
Treated with curative intent (not applicable for patients diagnosed with CLL/SLL)
18-79 years old
Has 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
Had a visit with their PCP in the previous 12 months
Patients will be approached for study participation within 120 days of starting their cancer treatment at Duke (except for men with prostate cancer on androgen deprivation therapy [ADT] and those previously on active surveillance). Those coming off active surveillance to receive treatment will be approached within the next 120 days. Men with prostate cancer that are on ADT can be approached for consent at any time while on treatment.
Supplement:
A sample size of 2800-3000 patients will be pulled from the Duke Cancer Registry. The retrospective cohort will consist of older adults ≥65 years who have ≥1 CVD comorbidity (hypertension, type 2 diabetes, dyslipidemia) and underwent cancer surgery for solid tumors (breast, prostate, colorectal, endometrial, gastric, esophageal, liver, pancreatic, renal cell, bladder, ovarian, head/neck, and non-small cell lung cancer) at DUHS from January 1st, 2017 to December 31st 2019.
The qualitative component of the supplement (Appendix IV: Aim 3) will involve 12-20 PCPs who arepart of the Duke Primary Care Research Consortium. Eligible PCP participants will be English-speaking providers who have provided care to ≥1 older adult patient who has undergone cancer surgery within a 12-month period at DUHS.

You may not qualify if…

Individuals with a history of the following conditions will be ineligible:
Myocardial infarction in the previous 24 months
Stage III-IV heart failure (EF <30%)
Stage IV-V chronic kidney disease (eGFR <30)
Neuroendocrine tumors
Uterine sarcomas
Bilateral axillary dissections - due to the inability to collect an upper extremity BP
Patients who are coming to Duke for surgery only and not planning to return are ineligible. Patients who cannot read, are blind or do not understand/speak English will not be enrolled.
Participants who progress to metastatic disease during the course of the 18-month study period will be allowed to continue to participate unless they voluntarily withdraw from the study.
Additional health information may be assessed on a case by case basis by the PI to determine if the individual is an appropriate candidate for the intervention.

Where it is running

Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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