TEAM-based Care for Cancer
(ONE TEAM Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am on my first or second treatment for CLL or SLL.

I am a man with prostate cancer currently receiving hormone therapy.

I had an organ transplant, but my kidney function is normal.

+8 more

Exclusion Criteria

I can stay in the study if my cancer spreads, unless I choose to leave.

I have been diagnosed with uterine sarcoma.

Patients who cannot read, are blind or do not understand/speak English

+6 more

Participant Groups

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.

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