- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448678
Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients (HIAYA CHAT)
Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this research is to refine and pilot test an existing health insurance education program (HIEP) to improve health insurance and cost-related literacy among adolescent and young adult (AYA) individuals who have recently been diagnosed with cancer. This study will be conducted within the Huntsman-Intermountain Adolescent and Young Adult (HI-AYA) Cancer Care Program, which is a unique collaboration between the Huntsman Cancer Institute and Intermountain Healthcare, the largest oncology providers in Utah. Initially, age-related differences related to health insurance and cost literacy among AYAs diagnosed with cancer ages 18-26 and 27-39 years will be identified, and the HIEP materials will be adapted accordingly. The HIEP delivered by the HI-AYA patient navigators, will be investigated to see if it improves participants' health insurance and cost-related literacy.
Upon enrollment, participants will fill out a survey containing questions about their current health insurance plan, financial status, demographics, health insurance knowledge, and financial toxicity. Participants will then be randomized into separate trial arms after which participants in both groups will meet with a HI-AYA patient navigator. Participants in the interventional arm will receive 4 educational sessions surrounding health insurance use and laws (four sessions total occurring approximately every two weeks). These educational sessions will be conducted, in person, over video conference calls, or over the telephone, and will cover:
- health insurance terms and concepts
- insurance coverage (insurance cards, bills, schedule and explanation on benefits)
- health insurance laws, rights and the appeals process
- budgeting and resources. These sessions will be scheduled with each participant according to their availability, with the goal of meeting every other week.
Approximately three months after meeting with the patient navigator, participants in both arms of the trial will fill out a second survey, including similar questions to those in the first survey as well as questions surrounding satisfaction with the HIEP and the patient navigator delivery for those who received the HIEP. After the post survey is complete, a small subset of participants in both the intervention and control arm will be randomly selected to complete an interview to better understand satisfaction with patient navigation, the intervention, recommendations for modifications on delivery modality, and recommendations for intervention topics and content modifications to identify components of the HIEP that require refinement prior to potential scaling of the intervention to a larger sample. Another small subset of participants will be randomly selected to complete an interview from the control arm to discuss their satisfaction with their patient navigation and to ask how they found resources concerning health insurance during their treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utah
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Murray, Utah, United States, 84107
- Intermountain Medical Center
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Were diagnosed with cancer between the ages of 18 and 39 AND
- Are within 1 year of a cancer diagnosis AND
- Are actively receiving chemotherapy, surgery, radiation, and/or hormonal therapy AND
- Are currently insured AND
- A patient at Primary Children's Hospital, Intermountain Medical Center or Huntsman Cancer Institute AND
- Speak English AND
- Have access to an electronic device compatible with video conferencing (e.g., smartphone, laptop, etc.).
Exclusion Criteria:
- Are unable to participate due to developmental delay OR
- Speak a language other than English OR
- Are currently uninsured OR
- Do not have access to an electronic device compatible with video conferencing (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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIEP intervention
Participants will be randomized to receive the insurance navigation intervention from patient navigators, which includes four, one hour long, educational learning sessions.
Randomization will be done by age at diagnosis and site.
|
[See arm/group descriptions]
|
Active Comparator: Usual Care
Participants will be randomized to receive standard navigation provided by patient navigators ("usual care").
|
[See arm/group descriptions]
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility Measurement
Time Frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
|
Comparing total number of individuals enrolled and randomized vs completed study (completion of both surveys for control or both surveys and all of the sessions for intervention.)
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Post-Assessment survey (Weeks 13 (+/- 2 weeks))
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Acceptability - Module Satisfaction
Time Frame: Post-Assessment interview (Weeks 18 (+/- 2 weeks))
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Questions surrounding satisfaction with the HIEP.
These will be asked at the post-assessment interview and will consist of participants responses surrounding satisfaction with the HIEP.
We will report percentages of participants who did 1 or more session and reported satisfaction with the HIEP.
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Post-Assessment interview (Weeks 18 (+/- 2 weeks))
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Navigator Satisfaction
Time Frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
|
Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey.
This score ranges from 0-45 with higher scores indicating higher satisfaction.
We will report the mean and standard deviation.
|
Post-Assessment survey (Weeks 13 (+/- 2 weeks))
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Efficacy- Health Insurance Literacy
Time Frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
|
Differences between Health Insurance Literacy Measure (HILM) reported at the intro baseline and exit post-assessment survey.
For this study, the last two sections (3&4) of the HILM were used.
Scores range from 9-36 with lower scores indicate lower health insurance literacy and worse outcomes.
Differences will be examined by age group and by treatment arm.
We report mean and standard deviation.
Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
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Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
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Changes in Efficacy- Affordable Care Act (ACA) Familiarity
Time Frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
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Questions surrounding familiarity with the ACA reported at the baseline and post-assessment survey.
Values range from 0 to 28 with higher scores indicating better familiarity with ACA concepts.
We will report the mean and standard deviation of the difference in response scores between baseline and post assessment for the control and intervention.
Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
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Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
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Changes in Efficacy-Financial Distress
Time Frame: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
|
Differences between COmprehensive Score for financial Toxicity (COST) reported at the baseline and post-assessment survey.
Values range from 0 to 44 where lower COST scores indicate worse financial toxicity.
Differences will be examined by age group and by treatment arm.
We will report mean and standard deviation.
Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
|
Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne C Kirchhoff, PhD, MPH, University of Utah Department of Pediatrics
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- IRB_00127029
- 1R01CA242729-01 (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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