Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients

Cancer Clinical Trial

— HIAYA CHAT  

Official title:

Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448678
• Other study ID #: IRB_00127029
• Secondary ID: 1R01CA242729-01
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: September 20, 2022

Study information

• Verified date: January 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a test of an existing health insurance education program (HIEP) in adolescent and young adult (AYA) individuals (aged 18-39) diagnosed with cancer. The study will evaluate whether the HIEP delivered by patient navigators improves participants' health insurance and cost-related literacy compared to usual navigation care, which does not include education on insurance and medical costs. The study team hypothesizes that: The HIEP will improve participants' health insurance and cost-related literacy compared to usual navigation care. Specifically, that participants in the intervention arm will report greater 1) health insurance and cost literacy, including confidence with provider communication about costs, 2) familiarity with ACA policies, and 3) improvement in financial distress related to medical costs. Participants will fill out a survey upon enrollment and a follow up survey 3 months after meeting with a patient navigator where they may or may not receive the HIEP.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Adolescent
• Cancer
• Young Adult

Intervention

Behavioral:
• Health Insurance Education Program (HIEP)
[See arm/group descriptions]

Other:
• Usual Care
[See arm/group descriptions]

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (5)

Lead Sponsor	Collaborator
University of Utah	Intermountain Health Care, Inc., Massachusetts General Hospital, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Measurement	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.)	Post-Assessment survey (Weeks 13 (+/- 2 weeks))
Primary	Acceptability - Module Satisfaction	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.	Post-Assessment interview (Weeks 18 (+/- 2 weeks))
Primary	Navigator Satisfaction	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))
Secondary	Changes in Efficacy- Health Insurance Literacy	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.	Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Secondary	Changes in Efficacy- Affordable Care Act (ACA) Familiarity	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.	Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Secondary	Changes in Efficacy-Financial Distress	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))