Improving Comprehensive Care of Cancer Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05323409
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • OPTIMISE — BEHAVIORAL
    OPTIMISE is a multilevel intervention that seeks to improve patient activation for comorbidity self-management during cancer treatment and coordination of care between oncologists and primary care physicians from point of diagnosis through the first year of post-treatment survivorship.

Study Details

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.

Key Dates

Start date
Apr 1, 2022
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: OPTIMISE
    OPTIMISE components to facilitate Patient self-management support are: 1) a bilingual oncology nurse navigator (ONN) and care coordination; 2) distress screening; 3) tailored comorbidity self-management action planning, 4) tailored survivorship action planning, and 5) surveillance reminders and follow-up. OPTIMISE components to facilitate provider decision support are: 1) when the initial referral is made, the ONN will send the PCP treatment plan summary (based on the ASCO treatment plan template) and standardized fact sheets on treatment toxicities; 2) throughout treatment, there will be bi-directional and structured communication between oncologist and PCP facilitated by the ONN; 3) The ONN will send the SCP to the PCP describing surveillance guidelines and summary of late effects. Finally, OPTIMISE will adopt a risk-stratified shared care model of post-treatment survivorship care.
  • No Intervention: Usual Medical Care (UMC)
    UMC consists of standard oncologic care from point of diagnosis. Cancer patients with comorbidities are encouraged by their oncologist to follow up with their PCP regarding comorbidity management but no formal referral process is in place. At the end of cancer treatment (with standard, definitive therapies), patients meet with a nurse (Survivorship Nurse Practitioner, NP) to review the SCP, which is based on ASCO templates and populated from the EHR. The Survivorship NP also reviews therapies received, recommended surveillance, common late effects, and recommended lifestyle behaviors. Patients are given a printed copy of the SCP and are encouraged to share this information with their PCP. Cancer surveillance follows the traditional oncologist led model regardless of patient risk for recurrence.

Primary Outcome Measure

Patient Activation Measure (PAM) [ Time Frame: 4 month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Hoda Badr, PhD
[email protected]
7137981588
Hoda Badr, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Baylor College of Medicine· Houston, TX

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