- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05829070
Improving Health Insurance Literacy Among Young Adult Cancer Survivors (CHAT-S)
A Randomized Controlled Trial to Improve Health Insurance Literacy and Surveillance Among Young Adult Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah
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Contact:
- Anne C Kirchhoff, PhD
- Phone Number: 801-587-4084
- Email: anne.kirchhoff@hci.utah.edu
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Contact:
- Perla Vaca Lopez, BA
- Email: Perla.VacaLopez@hci.utah.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHAT-S
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.
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The CHAT-S intervention will include 4 videoconference sessions over a 2-month time period that is delivered by a patient navigator.
Session 1 will include content to educate participants about survivorship care and common types of follow-up care required for their specific cancer, as well as, basic insurance terms and concepts.
Session 2 will teach participants about their own insurance plan (e.g., coverage, benefits, breakdown of bills, and explanation of benefits) so they can better navigate both the medical and insurance systems.
Session 3 reviews health insurance laws (e.g., ACA, FMLA, No Surprises Act) and how to proceed with an appeals process.
Session 4 explains how to manage the costs through budgeting and cost-of-care conversations with their medical providers.
|
Placebo Comparator: Usual Care
Usual care will consist of a resource list sent by the navigator.
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Usual care will consist of a resource list that describes organizational and community resources available on insurance, financial burden, and survivorship care.
Further, we will track whether participants were referred or engaged in services using the follow-up surveys and via the EHR/claims data.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Insurance Literacy Measure (HILM)
Time Frame: 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).
|
Baseline
|
COmprehensive Score for financial Toxicity (COST)
Time Frame: 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).
|
Baseline
|
Health Insurance Literacy Measure
Time Frame: 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).
|
6 months
|
COmprehensive Score for financial Toxicity (COST)
Time Frame: 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).
|
6 months
|
Health Insurance Literacy Measure
Time Frame: 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).
|
12 months
|
COmprehensive Score for financial Toxicity (COST)
Time Frame: 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).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surveillance for Recurrence
Time Frame: 18 months
|
Met (partly or fully) or failed to meet cancer surveillance for recurrence within the past year (looking from 6 months-18 months after baseline)
|
18 months
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Survivorship Care Receipt
Time Frame: 18 months
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Gathering information regarding receiving other survivorship care (other than surveillance care) including shared, coordinated care (e.g., using current procedural terminology codes to designate having visits in the past year-6-18 months following baseline-with both primary care providers and oncologists).
|
18 months
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Insurance Coverage
Time Frame: Baseline
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Questions asking about the type of insurance coverage participants have (having participants indicate if their coverage is public/private, policy holder, number of people covered etc).
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Baseline
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Insurance Coverage
Time Frame: 6 months
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Questions asking about the type of insurance coverage participants have (having participants indicate if their coverage is public/private, policy holder, number of people covered etc).
|
6 months
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Insurance Coverage
Time Frame: 12 months
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Questions asking about the type of insurance coverage participants have (having participants indicate if their coverage is public/private, policy holder, number of people covered etc).
|
12 months
|
COVID-19 Health Care Impacts
Time Frame: Baseline, 6 months, 12 months
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Questions regarding effects of pandemic on medical care access and financial consequences (including multiple choice options like "I stopped working completely," or "I changed my school status from full-time to part-time.")
|
Baseline, 6 months, 12 months
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COVID-19 Health Care Impacts
Time Frame: Baseline
|
Questions regarding effects of pandemic on medical care access and financial consequences (including multiple choice options like "I stopped working completely," or "I changed my school status from full-time to part-time.")
|
Baseline
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COVID-19 Health Care Impacts
Time Frame: 6 months
|
Questions regarding effects of pandemic on medical care access and financial consequences (including multiple choice options like "I stopped working completely," or "I changed my school status from full-time to part-time.")
|
6 months
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Familiarity with the Affordable Care Act and other insurance legislation
Time Frame: Baseline
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Knowledge of protections (e.g., appeals), avenues for insurance coverage, and legal protections.
Indicated using statements regarding familiarity with insurance legislation rated using a 4-point scale (very familiar, somewhat familiar, not too familiar, not at all familiar).
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Baseline
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Familiarity with the Affordable Care Act and other insurance legislation
Time Frame: 6 months
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Knowledge of protections (e.g., appeals), avenues for insurance coverage, and legal protections.
Indicated using statements regarding familiarity with insurance legislation rated using a 4-point scale (very familiar, somewhat familiar, not too familiar, not at all familiar).
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6 months
|
Familiarity with the Affordable Care Act and other insurance legislation
Time Frame: 12 months
|
Knowledge of protections (e.g., appeals), avenues for insurance coverage, and legal protections.
Indicated using statements regarding familiarity with insurance legislation rated using a 4-point scale (very familiar, somewhat familiar, not too familiar, not at all familiar).
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12 months
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Feasibility of enrollment and session completion
Time Frame: 6 months
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Percentage enrolled calculated from number approached for participation and sessions completed calculated from total number enrolled in the intervention.
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6 months
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Acceptability:
Time Frame: 6 months
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5-point scales of satisfaction with CHAT-S. Rating statements regarding the study with a 5-point scale (very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied). assistance that you wanted? How helpful has this program been for you for accessing survivorship care?) |
6 months
|
Patient Satisfaction with Interpersonal Relationship with Navigator
Time Frame: 6 months
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Experiences with communication and services provided by the navigator.
Using statements from the Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I).
Using a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
|
6 months
|
Cost related literacy
Time Frame: Baseline
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Confidence in dealing with medical costs indicated by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not at all confident).
|
Baseline
|
Cost related literacy
Time Frame: 6 months
|
Confidence in dealing with medical costs indicated by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not at all confident).
|
6 months
|
Cost related literacy
Time Frame: 12 months
|
Confidence in dealing with medical costs indicated by rating statements using a 4-point scale (very confident, somewhat confident, not too confident, not at all confident).
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01CA276825 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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