Proactive Costs of Care Study

NCT07217262 | Recruiting

• 1 other identifier: 00003960
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to 2 months

Secondary Outcomes (2)

• Change in Self-Efficacy using PROMIS Self-Efficacy

  From intervention to 3 months

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

  From intervention to 3 months

Study Arms (1)

Patient and Caregiver Arm of Proactive Costs of Care Study

EXPERIMENTAL

No comparator group

Behavioral: Educational Intervention

Interventions

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.

Patient and Caregiver Arm of Proactive Costs of Care Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- Caregivers to patients who satisfy the criteria above

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator
• Foundation for Women's Cancers: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Financial Stress; Caregiver Burden

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Margaret Liang, MD, MS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Fan Chen, BS

CONTACT

(323) 413-7804; Shu-Fan.Chen@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Staff Physician OBGYN

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 15, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)