Actively Recruiting
Optimise: Improving Comprehensive Care of Cancer Patients With Comorbidities
Led by Baylor College of Medicine · Updated on 2025-09-19
340
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cancer survivors often face challenges managing ongoing health issues alongside their cancer care, especially those with multiple chronic conditions and limited access to healthcare. This research evaluates OPTIMISE, a new shared care model designed to improve communication between oncologists and primary care providers for underserved patients with breast, gastrointestinal, or hematologic cancers who have additional health conditions. The study focuses on enhancing self-management of chronic diseases, quality of life, and care coordination from diagnosis through survivorship. Participants are randomly assigned to either the OPTIMISE program or usual medical care. OPTIMISE includes a bilingual oncology nurse navigator to coordinate care, culturally tailored self-management plans, structured communication between cancer specialists and primary care doctors, and a risk-based shared care approach where some cancer follow-up visits are replaced by primary care visits. Usual care involves standard oncologist-led treatment and surveillance with survivorship care plans provided at treatment completion. Throughout the study, patients complete surveys at multiple points from diagnosis through 12 months after survivorship care plan delivery. The nurse navigator supports patients with referrals, distress screening, action planning, and follow-up reminders. Researchers assess patient activation in managing chronic diseases, quality of life, healthcare usage, unmet needs, and provider attitudes toward care coordination. Interviews with patients and providers explore experiences and barriers to adopting the OPTIMISE model, aiming to improve care transitions and outcomes for medically underserved cancer survivors.
CONDITIONS
Brief Title
Improving Comprehensive Care of Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis or within three months of treatment start for early-stage breast (I-IIIB), gastrointestinal (Stage I-III), or hematologic (Stage I-III) cancer
- Receiving standard, definitive cancer treatments
- Having one or more chronic health conditions or unhealthy lifestyle habits needing ongoing management during cancer treatment
- Age over 18 years
- Able to speak and understand English or Spanish
- Able to provide informed consent
- Assigned to a Harris Health oncologist and primary care provider who agree to participate
You will not qualify if you...
- Significant cognitive impairment or inability to provide informed consent for patients
- No exclusion criteria listed for healthcare providers
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine clinic visit to introduce the study and obtain informed consent
Duration - From diagnosis through cancer treatment completion (variable duration)
Participants receive either usual medical care or the OPTIMISE behavioral intervention to support comorbidity self-management and coordination of care between oncologists and primary care providers during cancer treatment.
Routine clinic visits including initial oncology consult and subsequent visits at 2 and 4 months after treatment initiation
Duration - From diagnosis through cancer treatment completion (variable duration)
Participants randomized to OPTIMISE receive additional support including bilingual oncology nurse navigator care coordination, distress screening, tailored comorbidity self-management action planning, and communication between oncologists and primary care providers.
Routine oncology clinic visits at baseline, 2 months, and 4 months with follow-up by nurse navigator
Duration - Duration of survivorship care planning and transition period (variable)
After cancer treatment completion, participants meet with a survivorship nurse practitioner to review the survivorship care plan (SCP) and receive education on surveillance, late effects, and lifestyle behaviors. Participants receiving OPTIMISE collaborate with the nurse navigator to develop a tailored survivorship self-management action plan and receive referrals for primary care follow-up.
1 transition review visit with survivorship nurse practitioner and 1 follow-up visit with oncology nurse navigator
Duration - Up to 12 months post-treatment
Participants undergo cancer surveillance visits following either traditional oncologist-led care or a risk-stratified shared care model involving primary care providers, with reminders and follow-up support provided.
3 to 4 oncology surveillance visits and 1 or more primary care visits depending on risk stratification
Duration - Up to 12 months post-treatment
Participants complete scheduled surveys at baseline, during treatment, at survivorship care plan delivery, and up to 12 months after to assess patient activation, self-management, quality of life, and supportive care needs.
Surveys completed at baseline, 2 and 4 months after treatment start, at SCP delivery, and at 3, 6, and 12 months post SCP delivery
Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Hoda J. Badr, PhD
A
Aylin Diaz-Valladares, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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