Educational Intervention for Financial Burden in Gynecologic Cancers

(PCOC Trial)

SC
Overseen ByShu-Fan Chen, BS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help patients manage the costs associated with gynecologic cancer treatment. It tests an educational program called Proactive Costs of Care, a one-time, 30-minute session guiding patients on handling treatment expenses. The researchers aim to determine if this program can be effectively delivered and if it boosts confidence while reducing financial stress. This trial might suit someone diagnosed with gynecologic cancer, currently undergoing treatment at Cedars-Sinai Medical Center, and able to communicate in English. Participants will attend the educational session and complete two surveys to share their experiences. As an unphased trial, this study offers a unique opportunity to contribute to research that could ease financial burdens for future patients.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. It focuses on an educational session about managing the costs of cancer care.

What prior data suggests that this educational intervention is safe for patients with gynecologic cancers?

Research on the Proactive Costs of Care program is ongoing. So far, no published safety information or reports of problems exist for this specific program. This educational program aims to help patients manage cancer care costs and includes a one-time session with a guide and a cost tracker. Although documented safety data is not yet available, educational programs like this typically carry low risk because they do not involve medications or medical procedures. Participants will engage in discussions and complete surveys, which are generally easy and safe activities.12345

Why are researchers excited about this trial?

Researchers are excited about the Proactive Costs of Care Intervention because it addresses the financial burden faced by patients with gynecologic cancers, which is an aspect often overlooked in current treatment options. While standard treatments focus on medical and therapeutic approaches, this intervention is unique as it proactively educates patients about the costs associated with their care. By empowering patients with financial information and planning strategies, it aims to alleviate stress and improve overall well-being, potentially leading to better health outcomes. This innovative approach could pave the way for integrating financial education into cancer care, offering a more holistic treatment experience.

What evidence suggests that this educational intervention is effective for reducing financial distress in gynecologic cancer patients?

Research has shown that the costs of gynecologic cancer care can be very high and stressful. For example, the average yearly cost for ovarian cancer care exceeds $200,000. This financial stress can add to the emotional distress patients experience. In this trial, participants will receive the Proactive Costs of Care program, designed to help patients manage these expenses better. By teaching patients how to handle costs, this program may increase their confidence and reduce financial worries. Although specific data on the program's effectiveness is limited, focusing on financial education appears to be a promising way to ease financial burdens.678910

Who Is on the Research Team?

ML

Margaret Liang, MD, MS

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with gynecologic cancers who are starting new treatments and facing financial hardship. It's designed to help them manage the costs of cancer care. Participants must be willing to complete a 30-minute session and two surveys, one before and another three months after the intervention.

Inclusion Criteria

Receiving treatment at Cedars-Sinai Medical Center
Can speak, read, and understand English
I am 18 years old or older.
See 2 more

Exclusion Criteria

Cannot speak, read, or understand English
Patients whose records are flagged 'break the glass' or 'research opt out'
I am not willing to participate in the study or complete surveys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete the Proactive Costs of Care intervention, a one-time 30-minute session with a lay educator

1 day
1 visit (in-person, video, or phone)

Follow-up

Participants complete a follow-up survey to assess changes in financial distress and self-efficacy

3 months
1 survey (remote)

What Are the Treatments Tested in This Trial?

Interventions

  • Proactive Costs of Care Intervention
Trial Overview The Proactive Costs of Care Study tests an educational program aimed at improving patients' ability to handle the financial aspects of cancer treatment. The study measures success by participant completion rates, increased confidence in managing costs, and reduced financial distress.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Patient Arm of Proactive Costs of Care StudyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39159781/
Cost of ovarian cancer by the phase of care in the United StatesThe mean cost per year for ovarian cancer care was >$200,000 during the start of care, between $26,000 and $88,000 during the continuing care ...
Cost-effectiveness analyses in gynecologic oncologyThe total cost of cancer care in the United States was than US$180 billion dollars in 2000 [2]. In California alone, the total cost for gynecologic cancer care ...
GynOnc Healthcare EquityGynecologic cancers remain among the most lethal for women worldwide, causing the deaths of more than 600,000 women globally each year.
Gynecologic Cancer Prevention and Control in the ...Ovarian cancer was the most costly ($292 million), followed by cervical cancer ($206 million) and uterine cancer ($126 million). There are several evidence- ...
Cost of ovarian cancer by the phase of care in the United ...The mean cost per year for ovarian cancer care was >$200,000 during the start of care, between $26,000 and $88,000 during the continuing care ...
Proactive Costs of Care StudyStudy Results. Results pending. The study team has not published outcome measurements, participant flow, or safety data for this trial yet.
Proactive costs of care (PCOC) intervention for newly ...Results are presented in Table 1. COST score improved significantly over 6 months for PCOC vs. UC group (p = 0.02). Conclusions: This ...
The impact of comprehensive pharmaceutical care on ...Therefore, this study aimed to evaluate the impact of comprehensive pharmaceutical care on key medication safety outcomes in patients with ...
The Role of Preventive Nursing Interventions in Reducing ...The findings align with previous research, indicating that preventive nursing interventions can enhance clinical outcomes during complex cancer ...
Financial Toxicity in Patients With Gynecological Cancers87% of cervical cancer patients in Kenya delay care due to costs and 75% cannot afford diagnostic tests [31]. Patients in LMICs face a. 2.3 ...
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