An interventional study of Educational Intervention in Financial Burden, Financial Toxicity and Financial Stress, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Supportive care
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 and their caregivers by looking at how many participants complete the intervention. The other questions the trial aims to answer are whether the intervention can:
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.
The Proactive Costs of Care (PCOC) study aims to assess whether the Proactive Costs of Care intervention can be successfully delivered to cancer patients or their caregivers 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. Caregivers of patients who meet the eligibility criteria above are also 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 or their caregivers 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 patient 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. The caregiver survey will collect demographic information, confidence in solving problems, health insurance literacy, financial distress or well-being, and caregiver strain.
93 studies on the registry are indexed under Financial Stress; 32 are open to participants now.
This study's planned enrollment of 36 is below the median of 124 across 55 interventional studies indexed under Financial Stress.
Browse Financial Stress studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Patient Participants:
Inclusion Criteria for Caregiver Participants:
- Caregivers to patients who satisfy the criteria above
Exclusion Criteria for Patient and Caregiver Participants:
No comparator group
Behavioral: 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.
Participant Completion Rate of Educational Intervention
The number of participants who completed the intervention divided by the total number of participants who consented to the study
Time frame: From enrollment to 2 months
Change in Self-Efficacy using PROMIS Self-Efficacy
Scores range from 10-50, with higher scores indicating more self-efficacy
Time frame: From intervention to 3 months
Change in financial distress using InCharge Financial Distress/Financial Well-Being Scale
Scores range from 1-10, with higher scores indicating less financial distress
Time frame: From intervention to 3 months
Plan to share: No
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Cedars-Sinai Medical Center