Improving Comprehensive Care of Cancer Patients

NCT05323409 | Recruiting

• 1 other identifier: H-49731
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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-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.

Conditions

Breast Cancer; Gastrointestinal Cancer; Hematologic Cancer

Outcome Measures

Primary Outcomes (2)

• Patient Activation Measure (PAM)

  self-management attitudes

  4 month follow-up

• Instrument to measure Self-Management (IMSM)

  self-management behaviors

  4 month follow-up

Secondary Outcomes (2)

• Function Assessment of Cancer Therapy (FACT-G)

  4 month follow-up

• Supportive Care Needs Survey (SCNS)

  4 month follow-up

Study Arms (2)

OPTIMISE

EXPERIMENTAL

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.

Behavioral: OPTIMISE

Usual Medical Care (UMC)

NO INTERVENTION

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.

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.

OPTIMISE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For Patients: Significant cognitive impairment or Lack of capacity to consent For Providers: None

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hoda Badr

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoda J. Badr, PhD

CONTACT

7137981588; hoda.badr@bcm.edu

Aylin Diaz-Valladares, MA

CONTACT

7137985025; aylin.diaz-Valladares@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: April 12, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)