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NCT Number: NCT07217262

Proactive Costs of Care Study

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:

* 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Shu-Fan Chen

CONTACT

[email protected]

(323) 413-7804

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational intervention

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.

Primary outcomes

  1. Participant Completion Rate of Educational Intervention

    Time frame: From enrollment to 2 months

    The number of participants who completed the intervention divided by the total number of participants who consented to the study

Secondary outcomes

  1. Change in Self-Efficacy using PROMIS Self-Efficacy

    Time frame: From intervention to 3 months

    Scores range from 10-50, with higher scores indicating more self-efficacy

  2. Change in financial distress using InCharge Financial Distress/Financial Well-Being Scale

    Time frame: From intervention to 3 months

    Scores range from 1-10, with higher scores indicating less financial distress

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-Fan Chen, BS

CONTACT

[email protected]

(323) 413-7804

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Foundation for Women's Cancers
  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: PCOC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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