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Improving Comprehensive Care of Cancer Patients
NCT05323409 · View on ClinicalTrials.gov ↗
Study Summary
Cancer survivors have unique healthcare needs, including managing serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% of survivors have at least one comorbid chronic condition in addition to cancer, which complicates the delivery of quality cancer care. Medically underserved patients, who bear the highest burden of multiple chronic conditions, are at increased risk for poor outcomes during and after cancer treatment. Enhancing communication and collaboration between oncologists and primary care providers (PCPs) could improve health outcomes and care transitions for these patients, who often lack healthcare knowledge and access to supportive care. This study evaluates a novel shared care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary Care Partnership to Improve Comprehensive Survivorship Care), in the largest safety-net healthcare system in Houston, Texas. Three hundred newly diagnosed breast, gastrointestinal, and hematological cancer patients being treated with curative intent and having comorbidities requiring ongoing management will be randomized to either OPTIMISE or Usual Medical Care (UMC). UMC patients will receive cancer treatment directed by their oncologist, a survivorship care plan (SCP) at the end of active treatment, and surveillance visits based on national guidelines. OPTIMISE patients will: 1) have an oncology nurse navigator assigned to their care team at diagnosis to facilitate oncologist-PCP communication; 2) receive coordinated care between their oncologist and PCP throughout cancer treatment and surveillance, facilitated by structured communication and referral processes; 3) receive an SCP that incorporates comorbidity management; and 4) follow a risk-stratified shared care model where some routine oncologist follow-up visits are replaced by PCP visits. Aim 1a evaluates OPTIMISE's impact on patient chronic disease self-m
Conditions Studied
Interventions
- BEHAVIORAL OPTIMISE
Study Locations (1)
Texas
- Baylor College of Medicine — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2026-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05323409
The ClinicalTrials.gov registry entry for NCT05323409 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which OPTIMISE is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05323409 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05323409 about?
NCT05323409 is a clinical study titled "Improving Comprehensive Care of Cancer Patients". Cancer survivors have unique healthcare needs, including managing serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% of survivors have at least one comorbid chronic condition in addition to cancer, which complicates ...
What is the current status of trial NCT05323409?
This trial is currently recruiting. It is a NA study. The enrollment target is 340 participants. The study started on 2022-04-01. Estimated completion is 2026-06.
What conditions does trial NCT05323409 study?
This clinical trial studies the following conditions: Breast Cancer, Gastrointestinal Cancer, Hematologic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05323409?
The interventions under investigation include: OPTIMISE (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05323409?
This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05323409 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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