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临床试验/NCT05829070
NCT05829070招募中不适用

A Randomized Controlled Trial to Improve Health Insurance Literacy and Surveillance Among Young Adult Cancer Survivors

University of Utah3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年11月8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
300
试验地点
3
主要终点
Health Insurance Literacy Measure (HILM)

研究概览

简要总结

We will conduct a randomized controlled trial to test a 4-session virtual health insurance navigation intervention that will increase knowledge about health insurance, reduce financial burden, and improve surveillance for recurrence among 300 young adult cancer survivors ages 26 to 39. We will combine self-reported survey data with electronic health records and claims data to examine the trial outcomes and efficacy. We will also conduct an economic evaluation using cost-effectiveness and budget impact analyses, to establish the sustainability of the intervention at improving outcomes of young adult survivors through increasing their health insurance knowledge and decreasing their financial burden.

详细描述

The first year after cancer treatment ends is a critical time to establish survivorship care for young adult (YA) cancer survivors ages 26 to 39. Receipt of evidence-based survivorship care, including surveillance for cancer recurrence based on national guidelines, remain low among YA survivors. At the same time, YAs ages 26 to 39 have the highest rate of both uninsurance and underinsurance among adults in the United States. Our team's prior work demonstrated that YA cancer survivors report low understanding of their health insurance and the services it covers, which affects their ability to navigate care. Together, these issues can lead to significant access to care barriers and severe medical cost consequences for this population. This proposal addresses the urgent need to improve YA cancer survivors' health insurance literacy and decrease financial toxicity, thus improving their ability to receive recommended survivorship care. Guided by Andersen and Aday's Behavioral Model of Health Services Use, we developed and pilot-tested a 4-session virtual patient navigation intervention for YA cancer survivors that was adapted from a pilot program for childhood cancer survivors. Initial results support feasibility, acceptability, and preliminary efficacy of both of these pilot trials with YA survivors ages 26 to 39. We now propose a randomized controlled trial to test the efficacy of this program ("CHAT-S," Cancer Health insurAnce Tools with Survivors) to improve health insurance literacy, financial toxicity due to medical costs, and post-treatment surveillance for recurrence among YA cancer survivors ages 26 to 39 (up to age 45). We plan to randomize N=300 (N=200 intervention; N=100 usual care) YAs with breast, testicular, lymphoma, sarcoma, and colorectal cancer who have completed initial treatment within the past year from 14 locations in the University of Utah Healthcare (UUHC) and Intermountain Healthcare (IH) systems. UUHC and IH have many rural (20%) and Hispanic/Latinx (18%) YA cancer survivors; we will oversample these important subgroups. We will determine whether CHAT-S improves health insurance literacy and financial toxicity at 6-month follow-up (primary outcomes). Further, UUHC and IH have an integrated data infrastructure which allows us to capture electronic health records and claims data to investigate whether CHAT-S improves surveillance care for recurrence at 18-month follow-up (secondary outcome). We will explore moderators (e.g., rurality, ethnicity) of the intervention effects. Finally, to inform future dissemination, we will conduct a budget impact analysis and a short-term and long-term time horizon cost-effectiveness analysis of CHAT-S. This proposal addresses the National Cancer Institute's goal of improving the care of cancer survivors and mitigating financial toxicity. We will demonstrate that a virtual health insurance literacy intervention can improve insurance literacy, financial toxicity, and surveillance care among YA cancer survivors, and provide guidance to improving survivorship care across the United States.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
26 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants are eligible for this study if they:
  • Were diagnosed with breast, testicular, lymphoma, sarcoma, and colorectal cancer,
  • Are between the ages of 26 to 45 years (preferably between 26-39, but no older than 45),
  • Have completed initial treatment (i.e., radiation, chemotherapy, or surgery) within the past year,
  • Are a patient at the University of Utah/Huntsman Cancer Institute or Intermountain Healthcare, and
  • Speak English.

排除标准

  • Potential participants will be excluded if they:
  • Are unable to participate due to developmental delay, and
  • Speak a language other than English, and
  • Unable to participate through either phone or a video capable computer or mobile device (e.g., smartphone, laptop, etc.).

研究组 & 干预措施

CHAT-S

Experimental

CHAT-S consists of 4 bi-weekly 35-45 minute videoconferencing sessions with a patient navigator and a patient booklet on insurance, costs, and survivorship care.

干预措施: CHAT-S (Behavioral)

Usual Care

Placebo Comparator

Usual care will consist of a resource list sent by the navigator.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Health Insurance Literacy Measure (HILM)

时间窗: Baseline

The degree to which individuals have the knowledge, ability, and confidence to find and evaluate information about health plans, select the best plan for their own (or their family's) financial and health circumstances, and use the plan. Determined by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not all confident).

COmprehensive Score for financial Toxicity (COST)

时间窗: 12 months

Financial distress related to medical costs. Determined by rating statements regarding financial distress on a 5-point scale (very much, quite a bit, somewhat, a little bit, not at all).

Health Insurance Literacy Measure

时间窗: 12 months

The degree to which individuals have the knowledge, ability, and confidence to find and evaluate information about health plans, select the best plan for their own (or their family's) financial and health circumstances, and use the plan. Determined by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not all confident).

COmprehensive Score for financial Toxicity (COST)

时间窗: Baseline

Financial distress related to medical costs. Determined by rating statements regarding financial distress on a 5-point scale (very much, quite a bit, somewhat, a little bit, not at all).

Health Insurance Literacy Measure

时间窗: 6 months

The degree to which individuals have the knowledge, ability, and confidence to find and evaluate information about health plans, select the best plan for their own (or their family's) financial and health circumstances, and use the plan. Determined by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not all confident).

COmprehensive Score for financial Toxicity (COST)

时间窗: 6 months

Financial distress related to medical costs. Determined by rating statements regarding financial distress on a 5-point scale (very much, quite a bit, somewhat, a little bit, not at all).

次要结局

  • Surveillance for Recurrence(18 months)
  • Survivorship Care Receipt(18 months)
  • Insurance Coverage(12 months)
  • Familiarity with the Affordable Care Act and other insurance legislation(12 months)
  • Feasibility of enrollment and session completion(6 months)
  • Acceptability:(6 months)
  • Patient Satisfaction with Interpersonal Relationship with Navigator(6 months)
  • Cost related literacy(12 months)
  • Insurance Coverage(Baseline)
  • Insurance Coverage(6 months)
  • Familiarity with the Affordable Care Act and other insurance legislation(Baseline)
  • Familiarity with the Affordable Care Act and other insurance legislation(6 months)
  • Cost related literacy(Baseline)
  • Cost related literacy(6 months)

研究者

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

Anne Kirchhoff

Associate Professor, Pediatrics

University of Utah

研究点 (3)

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