跳至主要内容
临床试验/NCT07217262
NCT07217262招募中不适用

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

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Participant Completion Rate of Educational Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Patient and Caregiver Arm of Proactive Costs of Care Study

Experimental

No comparator group

干预措施: Educational Intervention (Behavioral)

结局指标

主要结局

Participant Completion Rate of Educational Intervention

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Liang

Principal Investigator, Staff Physician OBGYN

Cedars-Sinai Medical Center

研究点 (1)

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