Proactive Costs of Care Study

NCT ID: NCT07217262

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-04-30

Brief Summary

The Proactive Costs of Care intervention is an educational intervention designed to help patients deal with the cost of cancer care. The main goal of this trial is to evaluate whether the Proactive Costs of Care intervention can be successfully delivered to cancer patients who are starting a new treatment by looking at how many participants complete the intervention. The other questions the trial aims to answer are whether the intervention can:

• Improve confidence in solving problems related to costs of care
• Reduce distress related to finances

Participants will complete the Proactive Costs of Care intervention, which is an approximately 30-minute one-time session with a lay educator reviewing the Proactive Costs of Care Guide and Cost Tracker. The intervention can be completed in person, by video, and by phone. Participants will also complete two surveys- one to be completed before the intervention and one to be completed 3 months after the intervention.

Detailed Description

The Proactive Costs of Care (PCOC) study aims to assess whether the Proactive Costs of Care intervention can be successfully delivered to cancer patients and help them deal with the costs of cancer care. Patients who are over 18 years of age or older, diagnosed with gynecologic cancer (e.g. endometrial/uterine, cervical, ovarian, vulvar cancers), on active systemic therapy within 30 days of enrollment, receiving treatment at Cedars-Sinai Medical Center, and can speak, read, and understand English are eligible to participate.

The Proactive Costs of Care Guide and Cost Tracker were developed with the input of patients, caregivers, social workers, nurses, doctors, and other healthcare workers to address financial burden due to the cost of cancer care. The Proactive Costs of Care Guide covers 3 main topics; health insurance, employment, and personal and community support. The Proactive Costs of Care Cost Tracker helps patients track their medical costs. All of the materials are available in a paper version or electronic version.

Participants will complete a baseline survey before the intervention and a follow-up survey 3 months after the intervention. The survey will collect demographic information and ask questions about confidence in solving problems, health insurance literacy, financial distress or well-being, and emotional well-being.

Conditions

Financial Burden; Financial Toxicity; Financial Stress; Financial Navigation; Gynecologic Cancers

Keywords

Financial Navigation; Financial Toxicity; Financial Distress; Financial Burden; Gynecologic Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient Arm of Proactive Costs of Care Study

No comparator group

Group Type: OTHER

Educational Intervention

Intervention Type: BEHAVIORAL

Participants will receive the Proactive Costs of Care Guide that covers health insurance, employment, and finding personal and community support. They will also receive the Proactive Costs of Care Cost Tracker to help track medical costs. This one-time intervention can be completed in-person, by video, or by phone. A trained lay educator will spend approximately 30 minutes reviewing health insurance and discussing the 2-3 topics most relevant to the participant. All of the materials are available in a paper version or electronic version.

Interventions

Educational Intervention

Participants will receive the Proactive Costs of Care Guide that covers health insurance, employment, and finding personal and community support. They will also receive the Proactive Costs of Care Cost Tracker to help track medical costs. This one-time intervention can be completed in-person, by video, or by phone. A trained lay educator will spend approximately 30 minutes reviewing health insurance and discussing the 2-3 topics most relevant to the participant. All of the materials are available in a paper version or electronic version.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals 18 years old or older are included.
• Individuals diagnosed with gynecologic cancer
• On active systemic therapy within 30 days of enrollment
• Receiving treatment at Cedars-Sinai Medical Center
• Can speak, read, and understand English

Exclusion Criteria

• Any patients whose records are flagged "break the glass" or "research opt out."
• Cannot speak, read, or understand English
• Not willing to participate in the intervention or complete surveys

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Margaret Liang

Principal Investigator, Staff Physician OBGYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret Liang, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Central Contacts

Shu-Fan Chen, BS

Role: CONTACT

Phone: (323) 413-7804

Email: Shu-Fan.Chen@cshs.org

Facility Contacts

Shu-Fan Chen

Role: primary

Other Identifiers

00003960

Identifier Type: -

Identifier Source: org_study_id