Improving Comprehensive Care of Cancer Patients
Baylor College of Medicine · NCT05323409
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 340
- US sites recruiting
- 1
- Study start
- April 1, 2022
- Record last updated
- June 30, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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-management (primary outcome) and quality of life (secondary outcome). Aim 1b explores OPTIMISE's effects on healthcare use and patient unmet needs during and after treatment. Aim 2 examines OPTIMISE's impact on oncologist and PCP attitudes and care coordination. Aim 3 elucidates patient- and system-level factors influencing implementation outcomes. If effective, OPTIMISE could expand to other cancers and enhance care transitions in various medical settings.
Being studied: OPTIMISE
Conditions: Breast Cancer; Gastrointestinal Cancer; Hematologic Cancer
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- For patients: 1) new diagnosis or within three months of treatment initiation for early-stage breast (I-IIIB), GI (Stage I-III), or hematologic (Stage I-III) cancer 2) treatment with standard, definitive therapies (may include one or more modalities) 3) presence of one or more chronic comorbidities (e.g., diabetes, hypertension) and/or unhealthy lifestyle behaviors (e.g., overweight/obesity, current smoker, alcohol use) that require ongoing management during cancer treatment 4) age >18 years 5) fluency in English or Spanish 6) ability to provide informed consent 7) assignment to a Harris Health oncologist and PCP who are willing to participate and will provide informed consent.
For healthcare providers: 1) Person is an oncologist or PCP who treats patients with breast, GI, or hematologic malignancies at Harris Health BT/Smith Clinic
Exclusion Criteria
- For Patients: Significant cognitive impairment or Lack of capacity to consent For Providers: None
Recruiting US locations
Baylor College of Medicine
Houston, TX 77030
Site contact: Hoda Badr, PhD · 7137981588 · hoda.badr@bcm.edu
Study contacts (from the official record)
- Hoda J. Badr, PhD · 7137981588 · hoda.badr@bcm.edu
- Aylin Diaz-Valladares, MA · 7137985025 · aylin.diaz-Valladares@bcm.edu
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