Comprehensive Care Model for Cancer Survivors

Overseen By Aylin Diaz-Valladares, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 months

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for caring for cancer survivors with additional health issues, such as diabetes or high blood pressure. The goal is to enhance communication between cancer specialists and primary care doctors, simplifying health management for patients during and after cancer treatment. Participants will either receive this new approach or continue with standard care. This trial is ideal for individuals recently diagnosed with early-stage breast, gastrointestinal, or blood cancers who are also managing other chronic conditions. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could improve the quality of life for many.

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 prior data suggests that the OPTIMISE model is safe for cancer survivors with chronic comorbidities?

Research has shown that the OPTIMISE program aims to improve care for cancer survivors with other chronic health issues by enhancing communication between doctors. This program does not involve a new drug or risky procedure, resulting in very few safety concerns. A nurse will be assigned to help manage care and ensure effective collaboration among doctors.

Since this trial does not test a new medicine, the usual safety data from drug trials is not applicable. However, if OPTIMISE posed potential harm, it likely would not have reached this testing stage. The main goal is to improve communication and care, which carries minimal risk. Participants will receive coordinated care from healthcare providers, enhancing overall health management without introducing significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OPTIMISE protocol for cancer survivors because it offers a comprehensive approach to post-treatment care. Unlike standard care, which often lacks structured follow-up, OPTIMISE includes a bilingual oncology nurse navigator to coordinate care and ensure communication between oncologists and primary care providers. It also involves tailored action plans for managing comorbidities and cancer survivorship, along with regular distress screenings and surveillance reminders. This risk-stratified, shared care model aims to enhance patient self-management and improve overall outcomes, making it a promising advancement in survivorship care.

What evidence suggests that the OPTIMISE model is effective for improving care for cancer survivors with chronic comorbidities?

Research has shown that collaboration between cancer specialists and general practitioners can improve health outcomes for cancer survivors with other ongoing health issues. Studies indicate that clear communication and referral systems address these additional health needs effectively. In this trial, the OPTIMISE model, one of the study arms, aims to enhance communication between healthcare providers, which is believed to improve chronic disease management and increase patient satisfaction. This shared care approach is designed to make healthcare more accessible and effective for patients with complex medical needs. Meanwhile, the Usual Medical Care (UMC) arm follows standard oncologic care practices. For cancer survivors, timely and well-organized care can reduce the risk of complications and enhance their overall quality of life. ^{1 2 6 7 8}

Who Is on the Research Team?

Hoda Badr, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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

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

I am unable to understand or make decisions due to cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cancer treatment with either OPTIMISE or Usual Medical Care (UMC) models, including coordination between oncologists and PCPs for comorbidity management.

4 months

Routine clinic visits at 2 and 4 months after treatment initiation

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.

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up surveys at 3, 6, and 12 months post SCP delivery.

12 months

Surveys at 3, 6, and 12 months post SCP delivery

What Are the Treatments Tested in This Trial?

Interventions

• OPTIMISE

Trial Overview The OPTIMISE program is being tested against usual medical care. It includes an oncology nurse navigator to help coordinate between the patient's cancer doctor and primary care provider during treatment and survivorship planning that incorporates managing other health conditions.

How Is the Trial Designed?

Group I: OPTIMISE Experimental Treatment 1 Intervention

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.

Group II: Usual Medical Care (UMC) Active Control 1 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.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

The Ned algorithm is a nurse-led survivorship care model designed for men with prostate cancer, developed through collaboration with 20 clinical experts and 3 patient partners, aiming to improve decision-making and continuity of care.

This algorithm includes a structured alert system based on patient responses, allowing for timely interventions and empowering patients to manage their symptoms, although further validation through trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Actionable Expert-System Algorithm to Support Nurse-Led Cancer Survivorship Care: Algorithm Development Study. Pfisterer, KJ., Lohani, R., Janes, E., et al.[2023]

A systematic review of 11 studies, including 8 randomized controlled trials, found that the shared care model for cancer survivors is as effective as usual care in terms of quality of life and clinical outcomes, while also being highly acceptable to patients and practitioners.

Patient satisfaction with shared care was reported to be higher than with usual care, suggesting that improved communication between primary and hospital care can enhance follow-up for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. Zhao, Y., Brettle, A., Qiu, L.[2022]

The Cancer Treatment Summary and Follow-Up Care Plan is a new model designed to support breast cancer survivors in transitioning from active treatment to ongoing care, addressing complex health issues that may arise post-treatment.

This survivorship care plan promotes better coordination of services and encourages oncology nurses to play a key role in facilitating interdisciplinary collaboration, shifting the focus from acute care to a wellness-oriented approach for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a survivorship care plan for patients with breast cancer. Miller, R.[2022]

Integrating palliative care (PC) into survivorship care for cancer survivors shows promise, with 20 articles reviewed highlighting various multidisciplinary models that address physical, psychological, and social needs.

Some studies indicated that this integrated approach can lead to improvements in pain management, self-efficacy, depression, and overall function, but the overall evidence is limited, suggesting a need for more rigorous research to evaluate outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the gap: Palliative care integration into survivorship care. Morgan, B., Kapadia, V., Crawford, L., et al.[2023]

The review analyzed 25 studies on survivorship care models for cancer survivors, focusing on breast, colorectal, and adolescent/young adult (AYA) cancers, highlighting the shared-care model as common across all types and the multidisciplinary model as key for AYA survivors.

Despite the comprehensiveness of these models, there is a significant gap in rigorous evaluations of their effectiveness, particularly in care coordination, which needs improvement to enhance quality of life and health outcomes for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care models for breast cancer, colorectal cancer, and adolescent and young adult (AYA) cancer survivors: a systematic review. Ke, Y., Ng, T., Chan, A.[2019]

Cancer survivors face lifelong risks of late effects from their treatment, which can lead to serious health issues, highlighting the importance of regular long-term follow-up care.

The 'Personalized Cancer Survivorship Care Model' developed in this study emphasizes personalized, multidisciplinary care that empowers survivors and supports self-management, aiming to improve health outcomes and cost-effectiveness across various healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Survivorship Care: Person Centered Care in a Multidisciplinary Shared Care Model. Loonen, JJ., Blijlevens, NM., Prins, J., et al.[2020]

A review of 12 systematic studies involving 53 primary studies found that different models of post-treatment cancer survivorship care, including nurse-led and primary care provider-led models, are equally effective in managing survivors' physical and psychosocial outcomes.

Implementing these alternative care models could lead to cost savings for both cancer survivors and healthcare systems, but barriers such as limited resources and communication issues hinder their widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and implementation of models of cancer survivorship care: an overview of systematic reviews. Chan, RJ., Crawford-Williams, F., Crichton, M., et al.[2023]

Citations

1. merck.com merck.com/news/lynparza-olaparib-demonstrated-clinically-meaningful-prolonged-survival-benefit-in-early-breast-cancer-in-olympia-phase-3-trial/

LYNPARZA® (olaparib) Demonstrated Clinically ... LYNPARZA (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.01549

Overall Survival With Maintenance Olaparib at a 7-Year ... Results indicate a clinically meaningful, albeit not statistically significant, improvement in OS with maintenance olaparib versus placebo, with ...

3. astrazeneca.com astrazeneca.com/media-centre/press-releases/2024/lynparza-demonstrated-clinically-meaningful-prolonged-survival-benefit-in-early-breast-cancer-in-olympia-phase-iii-trial.html

Lynparza demonstrated clinically meaningful prolonged ... 87.5% of patients treated with Lynparza were alive at six years vs. 83.2% in the comparator arm. First and only PARP inhibitor to improve ...

4. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2024/lynparza-demonstrated-clinically-meaningful-prolonged-survival-benefit-in-early-breast-cancer-in-olympia-phase-iii-trial.html

LYNPARZA® (olaparib) demonstrated clinically meaningful ... 87.5% of patients treated with LYNPARZA were alive at six years vs. 83.2% in the comparator arm. First and only PARP inhibitor to improve ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223334/

Cancer treatment and survivorship statistics, 2025 The number of people living in the United States with a history of cancer is rising because of advances in detection and treatment that have improved survival.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36082969/

Overall Survival With Maintenance Olaparib at a 7 ... - PubMed At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not ...

7. aacr.org aacr.org/about-the-aacr/newsroom/news-releases/parp-inhibition-shows-long-term-survival-benefits-for-patients-with-high-risk-brca-positive-breast-cancer-in-olympia-trial/

PARP Inhibition Shows Long-term Survival Benefits ... At six years, 79.6% of olaparib-treated patients remained free of invasive recurrence and 83.5% remained free of distant recurrence, compared to ...

8. lynparzahcp.com lynparzahcp.com/ovarian-cancer/efficacy/solo-1.html

LYNPARZA SOLO-1 Trial: Efficacy in Ovarian Cancer | For HCPs In SOLO-1, treatment with LYNPARZA was continued for up to 2 years or until disease progression or unacceptable toxicity.