Financial BurdenPCOCNCT07217262
Proactive Costs of Care Study
A study testing Educational Intervention in people with Financial Burden and Financial Toxicity, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Financial Burden, Financial Toxicity, Financial Stress
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Shu-Fan Chen, (323) 413-7804, Shu-Fan.Chen@cshs.org
About this study
Official 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
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.
Read the 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 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.
- Conditions
- Financial Burden, Financial Toxicity, Financial Stress, Financial Navigation, Gynecologic Cancers, Caregiver Burnout
- Being tested
- Educational Intervention
- Keywords
- Financial Navigation, Financial Toxicity, Financial Distress, Financial Burden, Gynecologic Cancers, Caregiver Burnout
- Medical subject headings
- Financial Stress, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient and Caregiver Arm of Proactive Costs of Care Study | Experimental | No comparator group Receives: Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 2 months
Secondary outcomes (2)
Change in Self-Efficacy using PROMIS Self-Efficacy
Scores range from 10-50, with higher scores indicating more self-efficacy
Measured: 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
Measured: From intervention to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start22 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Foundation for Women's Cancers
- Responsible party
- Principal investigator, Margaret Liang, Cedars-Sinai Medical Center
- Investigators
- Margaret Liang, MD, MS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217262
- Sponsor's protocol ID
- 00003960
- Acronym
- PCOC
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07217262
- Acronym / sponsor ID
- PCOC / 00003960
- Conditions
- Financial Burden, Financial Toxicity, Financial Stress, Financial Navigation, Gynecologic Cancers, Caregiver Burnout
- Keywords
- Financial Navigation, Financial Toxicity, Financial Distress, Financial Burden, Gynecologic Cancers, Caregiver Burnout
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Foundation for Women's Cancers
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient and Caregiver Arm of Proactive Costs of Care Study | Experimental | Behavioral: Educational InterventionNo comparator group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionParticipants 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. | Behavioural | Patient and Caregiver Arm of Proactive Costs of Care Study |
Primary outcome
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
2 secondary outcomes
Change in Self-Efficacy using PROMIS Self-Efficacy
Time frame: From intervention to 3 months
Change in financial distress using InCharge Financial Distress/Financial Well-Being Scale
Time frame: From intervention to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret Liang, MD, MS principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Financial Burden and Financial Toxicity, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu-Fan Chen, BS ((323) 413-7804, Shu-Fan.Chen@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Completion Rate of Educational Intervention (time frame: From enrollment to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.