Comprehensive Care Model for Cancer Survivors
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on managing chronic conditions alongside cancer treatment, so it's likely you can continue your medications, but you should confirm with the trial coordinators.
What data supports the effectiveness of the treatment OPTIMISE, Lynparza for cancer survivors?
The research highlights the importance of comprehensive care models for cancer survivors, which can address physical and psychological needs. While specific data on OPTIMISE, Lynparza is not provided, integrated care models have shown improvements in areas like pain and depression, suggesting potential benefits for similar treatments.12345
How is the Comprehensive Care Model for Cancer Survivors different from other treatments?
The Comprehensive Care Model for Cancer Survivors is unique because it integrates palliative care (supportive care for serious illness) into survivorship care, addressing not just physical health but also psychological and social needs. This model shifts from a traditional medical approach to a wellness-focused approach, aiming to improve coordination of care and address long-term health needs after cancer treatment.13567
Research Team
Hoda Badr, PhD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for adults over 18 with a new or recent diagnosis of early-stage breast, GI, or blood cancer who are undergoing standard treatments. They must also have chronic conditions like diabetes or hypertension, engage in unhealthy lifestyle behaviors, and be fluent in English or Spanish. Both their oncologist and primary care provider must agree to participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cancer treatment with either OPTIMISE or Usual Medical Care (UMC) models, including coordination between oncologists and PCPs for comorbidity management.
Survivorship Care Planning
Participants receive a survivorship care plan (SCP) at the end of active treatment, which includes reviews of therapies received, recommended surveillance, and lifestyle modifications.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up surveys at 3, 6, and 12 months post SCP delivery.
Treatment Details
Interventions
- OPTIMISE
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor