Proactive Costs of Care support for people with gynecologic cancer
An Open, Single-arm, Single-site Study to Evaluate the Proactive Costs of Care (PCOC) Intervention Delivered by a Trained Lay Educator to Test Feasibility With the Goal of Improving Self-efficacy Among Patients With Gynecologic Cancer on Active Therapy and Their Caregivers
NA · Cedars-Sinai Medical Center · NCT07217262
This one-time, 30-minute educational session tries to help adults with gynecologic cancer (or their caregivers) who are starting a new systemic therapy learn to track medical costs, understand insurance and resources, and reduce financial stress.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07217262 on ClinicalTrials.gov |
What this trial studies
The Proactive Costs of Care (PCOC) intervention is a single approximately 30-minute session led by a lay educator who reviews a Proactive Costs of Care Guide and a Cost Tracker; materials are available on paper or electronically. The session can be delivered in person, by video, or by phone to patients with gynecologic cancers who are starting systemic therapy and to their caregivers at Cedars‑Sinai. Participants complete a baseline survey before the intervention and a follow-up survey three months later to measure completion, confidence in solving cost-related problems, health insurance literacy, and financial distress. The main goal is to measure feasibility (completion rate), with secondary interest in changes in confidence and financial distress.
Who should consider this trial
Good fit: Adults (18+) with gynecologic cancer who are on active systemic therapy within 30 days of enrollment, receiving care at Cedars‑Sinai Medical Center, English-speaking, or their caregivers are ideal candidates.
Not a fit: People who do not speak or read English, are not receiving care at Cedars‑Sinai, are not on active systemic therapy, or are unwilling to complete the session and surveys are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could help patients and caregivers feel more confident managing insurance, employment, and out-of-pocket medical costs and reduce financial distress.
How similar studies have performed: Prior financial-navigation and educational interventions have shown modest improvements in financial distress and patient confidence in some settings, but results vary and this specific guide/tracker combination is a newer approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Patient Participants: * 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 Inclusion Criteria for Caregiver Participants: \- Caregivers to patients who satisfy the criteria above Exclusion Criteria for Patient and Caregiver Participants: * 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
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Margaret Liang, MD, MS — Cedars-Sinai Medical Center
- Study coordinator: Shu-Fan Chen, BS
- Email: Shu-Fan.Chen@cshs.org
- Phone: (323) 413-7804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Financial Burden, Financial Toxicity, Financial Stress, Financial Navigation, Gynecologic Cancers, Caregiver Burnout, Financial Distress