AdolescentHIAYA CHATNCT04448678
Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients
A study testing Health Insurance Education Program (HIEP) in people with Adolescent and Young Adult, run by University of Utah at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Adolescent, Young Adult, Cancer
- What is being tested?
- Health Insurance Education Program (HIEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Oct 2020to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.).
Who cannot join
- 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.).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Intermountain Medical Center
Murray, Utah, 84107
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
Official title: Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study
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.
Read the 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.
- Conditions
- Adolescent, Young Adult, Cancer
- Being tested
- Health Insurance Education Program (HIEP), Usual Care
- Keywords
- Education, Insurance
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Insurance Education Program (HIEP)Behavioural
[See arm/group descriptions]
Usual CareOther
[See arm/group descriptions]
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health Insurance Education Program (HIEP) |
| Usual Care | Active comparator | Participants will be randomized to receive standard navigation provided by patient navigators ("usual care"). Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: 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.
Measured: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start21 Oct 2020
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdolescentStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Health Care, Inc., Massachusetts General Hospital, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anne Kirchhoff, University of Utah
- Investigators
- Anne C Kirchhoff, PhD, MPH, Principal investigator, University of Utah Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448678
- Sponsor's protocol ID
- IRB_00127029
- Other IDs
- 1R01CA242729-01
- Acronym
- HIAYA CHAT
- Status last verified
- Jan 2024
- First submitted
- 22 Jun 2020
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36706435Mann 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.
PubMed 35986416
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huntsman Intermountain Adolescent and Young Adult Cancer Care Program- Cancer Health Insurance Tool Study
- ClinicalTrials.gov ID
- NCT04448678
- Acronym / sponsor ID
- HIAYA CHAT / IRB_00127029
- Conditions
- Adolescent, Young Adult, Cancer
- Keywords
- Education, Insurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Health Care, Inc., Massachusetts General Hospital, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIEP intervention | Experimental | Behavioral: Health Insurance Education Program (HIEP)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 | Other: Usual CareParticipants will be randomized to receive standard navigation provided by patient navigators ("usual care"). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Insurance Education Program (HIEP)[See arm/group descriptions] | Behavioural | HIEP intervention |
| Usual Care[See arm/group descriptions] | Other | Usual Care |
Primary outcome
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.)
Acceptability - Module Satisfaction
Time frame: Post-Assessment interview (Weeks 18 (+/- 2 weeks))
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.
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.
3 secondary outcomes
Changes in Efficacy- Health Insurance Literacy
Time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Changes in Efficacy- Affordable Care Act (ACA) Familiarity
Time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Changes in Efficacy-Financial Distress
Time frame: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36706435Vaca 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.
- Derived from this study: PubMed 35986416Mann 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.
- Individual participant dataSharing planned: No
Related trials for Adolescent
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne C Kirchhoff, PhD, MPH principal investigator
University of Utah Department of Pediatrics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Insurance Education Program (HIEP) in people with Adolescent and Young Adult, run by University of Utah at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Measurement (time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448678, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.