Caregiver Burnout, Financial Burden, Financial Navigation, Financial Stress, Financial Toxicity, Gynecologic Cancers
Conditions
Keywords
Financial Navigation, Financial Toxicity, Financial Distress, Financial Burden, Gynecologic Cancers, Caregiver Burnout
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.
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.
Interventions
BEHAVIORALEducational 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.
Sponsors
Cedars-Sinai Medical Center
Merck Sharp & Dohme LLC
Foundation for Women's Cancers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Completion Rate of Educational Intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Efficacy using PROMIS Self-Efficacy | From intervention to 3 months | Scores range from 10-50, with higher scores indicating more self-efficacy |
| Change in financial distress using InCharge Financial Distress/Financial Well-Being Scale | From intervention to 3 months | Scores range from 1-10, with higher scores indicating less financial distress |
Countries
United States
Contacts
CONTACTShu-Fan Chen, BS
PRINCIPAL_INVESTIGATORMargaret Liang, MD, MS
Cedars-Sinai Medical Center
Outcome results
None listed