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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA242729-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Intermountain Health Care, Inc. | OTHER |
| Massachusetts General Hospital | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIEP intervention | Experimental | 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. |
|
| Usual Care | Active Comparator | Participants will be randomized to receive standard navigation provided by patient navigators ("usual care"). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Insurance Education Program (HIEP) | Behavioral | [See arm/group descriptions] |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
| 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)) |
| 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne C Kirchhoff, PhD, MPH | University of Utah Department of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84107 | United States | ||
| Huntsman Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36706435 | Derived | Vaca Lopez PL, Warner EL, Waters AR, van Thiel Berghuijs KM, Anderson JS, Ray N, Tsukamoto T, Kaddas HK, Fair D, Lewis M, Park ER, Perez GK, Kirchhoff AC. Adaptation and Development of a Health Insurance Education Program for Adolescent and Young Adult Cancer Patients. J Adolesc Young Adult Oncol. 2023 Oct;12(5):692-700. doi: 10.1089/jayao.2022.0103. Epub 2023 Jan 27. | |
| 35986416 | Derived | Mann K, Waters AR, Park ER, Perez GK, Vaca Lopez PL, Kaddas HK, Warner EL, Ray N, Tsukamoto T, Allen K, Haaland B, Fair DB, Lewis MA, Kirchhoff AC. HIAYA CHAT study protocol: a randomized controlled trial of a health insurance education intervention for newly diagnosed adolescent and young adult cancer patients. Trials. 2022 Aug 19;23(1):682. doi: 10.1186/s13063-022-06590-5. |
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We decided to overshoot our original target just to have the extra data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Health Insurance Education Program (HIEP): [See arm/group descriptions] |
| FG001 | Usual Care | Participants will be randomized to receive standard navigation provided by patient navigators ("usual care"). Usual Care: [See arm/group descriptions] |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Health Insurance Education Program (HIEP): [See arm/group descriptions] |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network. | Posted | Count of Participants | Participants | Post-Assessment survey (Weeks 13 (+/- 2 weeks)) |
|
Adverse events were not monitored for this study;.
As this study was an educational intervention on health insurance, mortality, serious and non-serious adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Health Insurance Education Program (HIEP): [See arm/group descriptions] |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Kirchhoff | University of Utah | 801-587-4084 | Anne.Kirchhoff@hci.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2020 | Oct 27, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2023 | Nov 3, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: UniversityofUtah | Mar 2, 2020 | Oct 15, 2020 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: IntermountainHealthCare | May 7, 2020 | Oct 15, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| NIH |
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Participants will not know who is receiving additional health insurance navigation or standard navigation. The outcome assessor will also be blinded to which participants received health insurance navigation. Blinding for the outcome assessor will be kept throughout the entirety of the analysis. Groups will be identified for analysis with ambiguous categories such as group 1 and group 2.
| Usual Care | Other | [See arm/group descriptions] |
|
| Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)) |
| 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)) |
| 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)) |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Usual Care |
Participants will be randomized to receive standard navigation provided by patient navigators ("usual care"). Usual Care: [See arm/group descriptions] |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| COmprehensive Score for financial Toxicity (COST) | The COST Score is a validated patient reported outcome measure which screens for financial toxicity in cancer patients. Lower scores indicate increased financial toxicity or worse outcomes. Scores range from 0-44. | Some of the participants (n=4) did not fill in all of the fields required for us to analyze their COST score. | Mean | Standard Deviation | Score on a scale |
|
| Health Insurance Literacy Measure (HILM) | The HILM is a validated measure that assess a patients health insurance literacy and which areas a patient may need additional assistance with insurance issues. Traditionally, the measure consists of 4 categories, confidence choosing health insurance, comparing health plans, confidence using health insurance and being proactive with health insurance. For this study, we focused on sections concerning confidence using health insurance and being proactive with health insurance. Scores range from 9-36. Lower scores indicate lower health insurance literacy and worse outcomes. | Some of the participants (n=1) did not fill in all of the fields required for us to analyze their HILM score. | Mean | Standard Deviation | Score on a scale |
|
Number of participants who were randomized into the Health Insurance Educational Program versus those who completed the study (all 4 sessions and the follow up survey).
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| 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. | Analysis of participants satisfaction from questions asked in the exit interview. Only including participants who were randomized into the intervention, then the exit interviews, and completed at least one session of the HIEP. | Posted | Count of Participants | Participants | Post-Assessment interview (Weeks 18 (+/- 2 weeks)) |
|
|
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| 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. | Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network. | Posted | Mean | Standard Deviation | score on a scale | Post-Assessment survey (Weeks 13 (+/- 2 weeks)) |
|
|
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| 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. | Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)) |
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|
|
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| 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. | Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)) |
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| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks)) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | Participants will be randomized to receive standard navigation provided by patient navigators ("usual care"). Usual Care: [See arm/group descriptions] | 0 | 0 | 0 | 0 | 0 | 0 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Combined (18-39) |
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