CancerCHAT-SNCT05829070
Improving Health Insurance Literacy Among Young Adult Cancer Survivors
A study testing CHAT-S in people with Cancer, run by University of Utah at 2 sites in United States.
Trial summary
We will conduct a randomized controlled trial to test a 4-session virtual health insurance navigation intervention that will increase knowledge about health insurance, reduce financial burden, and improve surveillance for recurrence among 300 young adult cancer survivors ages 26 to 39. Read more about this study
- Who is it for?
- Ages 26 to 45 years
- Conditions the study is for
- Cancer
- What is being tested?
- CHAT-S
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2023to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 26 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cindy Turner, MPH contact
United States2 sites, 2 recruiting
- Recruiting
Intermountain Health
Murray, Utah, 84107
Mark Lewis, MD, 801-507-3630
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Anne C Kirchhoff, PhD, 801-587-4084, anne.kirchhoff@hci.utah.edu
Perla Vaca Lopez, BA, Perla.VacaLopez@hci.utah.edu
About this study
Official title: A Randomized Controlled Trial to Improve Health Insurance Literacy and Surveillance Among Young Adult Cancer Survivors
We will conduct a randomized controlled trial to test a 4-session virtual health insurance navigation intervention that will increase knowledge about health insurance, reduce financial burden, and improve surveillance for recurrence among 300 young adult cancer survivors ages 26 to 39. We will combine self-reported survey data with electronic health records and claims data to examine the trial outcomes and efficacy. We will also conduct an economic evaluation using cost-effectiveness and budget impact analyses, to establish the sustainability of the intervention at improving outcomes of young adult survivors through increasing their health insurance knowledge and decreasing their financial burden.
Read the detailed description
The first year after cancer treatment ends is a critical time to establish survivorship care for young adult (YA) cancer survivors ages 26 to 39. Receipt of evidence-based survivorship care, including surveillance for cancer recurrence based on national guidelines, remain low among YA survivors. At the same time, YAs ages 26 to 39 have the highest rate of both uninsurance and underinsurance among adults in the United States. Our team's prior work demonstrated that YA cancer survivors report low understanding of their health insurance and the services it covers, which affects their ability to navigate care. Together, these issues can lead to significant access to care barriers and severe medical cost consequences for this population. This proposal addresses the urgent need to improve YA cancer survivors' health insurance literacy and decrease financial toxicity, thus improving their ability to receive recommended survivorship care. Guided by Andersen and Aday's Behavioral Model of Health Services Use, we developed and pilot-tested a 4-session virtual patient navigation intervention for YA cancer survivors that was adapted from a pilot program for childhood cancer survivors. Initial results support feasibility, acceptability, and preliminary efficacy of both of these pilot trials with YA survivors ages 26 to 39. We now propose a randomized controlled trial to test the efficacy of this program ("CHAT-S," Cancer Health insurAnce Tools with Survivors) to improve health insurance literacy, financial toxicity due to medical costs, and post-treatment surveillance for recurrence among YA cancer survivors ages 26 to 39 (up to age 45). We plan to randomize N=300 (N=200 intervention; N=100 usual care) YAs with breast, testicular, lymphoma, sarcoma, and colorectal cancer who have completed initial treatment within the past year from 14 locations in the University of Utah Healthcare (UUHC) and Intermountain Healthcare (IH) systems. UUHC and IH have many rural (20%) and Hispanic/Latinx (18%) YA cancer survivors; we will oversample these important subgroups. We will determine whether CHAT-S improves health insurance literacy and financial toxicity at 6-month follow-up (primary outcomes). Further, UUHC and IH have an integrated data infrastructure which allows us to capture electronic health records and claims data to investigate whether CHAT-S improves surveillance care for recurrence at 18-month follow-up (secondary outcome). We will explore moderators (e.g., rurality, ethnicity) of the intervention effects. Finally, to inform future dissemination, we will conduct a budget impact analysis and a short-term and long-term time horizon cost-effectiveness analysis of CHAT-S. This proposal addresses the National Cancer Institute's goal of improving the care of cancer survivors and mitigating financial toxicity. We will demonstrate that a virtual health insurance literacy intervention can improve insurance literacy, financial toxicity, and surveillance care among YA cancer survivors, and provide guidance to improving survivorship care across the United States.
- Conditions
- Cancer
- Being tested
- CHAT-S, Usual Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAT-SBehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CHAT-S | Experimental | 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. Receives: Behavioral: CHAT-S |
| Usual Care | Placebo comparator | Usual care will consist of a resource list sent by the navigator. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Insurance Literacy Measure (HILM)
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).
Measured: Baseline
COmprehensive Score for financial Toxicity (COST)
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).
Measured: Baseline
Health Insurance Literacy Measure
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).
Measured: 6 months
COmprehensive Score for financial Toxicity (COST)
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).
Measured: 6 months
Health Insurance Literacy Measure
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).
Measured: 12 months
COmprehensive Score for financial Toxicity (COST)
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).
Measured: 12 months
Secondary outcomes (14)
Surveillance for Recurrence
Met (partly or fully) or failed to meet cancer surveillance for recurrence within the past year (looking from 6 months-18 months after baseline)
Measured: 18 months
Survivorship Care Receipt
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).
Measured: 18 months
Insurance Coverage
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).
Measured: Baseline
Insurance Coverage
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).
Measured: 6 months
Insurance Coverage
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).
Measured: 12 months
Familiarity with the Affordable Care Act and other insurance legislation
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).
Measured: Baseline
Familiarity with the Affordable Care Act and other insurance legislation
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).
Measured: 6 months
Familiarity with the Affordable Care Act and other insurance legislation
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).
Measured: 12 months
Feasibility of enrollment and session completion
Percentage enrolled calculated from number approached for participation and sessions completed calculated from total number enrolled in the intervention.
Measured: 6 months
Acceptability:
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?)
Measured: 6 months
Patient Satisfaction with Interpersonal Relationship with Navigator
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).
Measured: 6 months
Cost related literacy
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).
Measured: Baseline
Cost related literacy
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).
Measured: 6 months
Cost related literacy
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start8 Nov 2023
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Health Care, Inc., Massachusetts General Hospital, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anne Kirchhoff, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829070
- Sponsor's protocol ID
- 00164028
- Other IDs
- R01CA276825
- Acronym
- CHAT-S
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Improve Health Insurance Literacy and Surveillance Among Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05829070
- Acronym / sponsor ID
- CHAT-S / 00164028
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Health Care, Inc., Massachusetts General Hospital, National Cancer Institute (NCI)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will conduct a randomized controlled trial to test a 4-session virtual health insurance navigation intervention that will increase knowledge about health insurance, reduce financial burden, and improve surveillance for recurrence among 300 young adult cancer survivors ages 26 to 39. We will combine self-reported survey data with electronic health records and claims data to examine the trial outcomes and efficacy. We will also conduct an economic evaluation using cost-effectiveness and budget impact analyses, to establish the sustainability of the intervention at improving outcomes of young adult survivors through increasing their health insurance knowledge and decreasing their financial burden.
Detailed description
The first year after cancer treatment ends is a critical time to establish survivorship care for young adult (YA) cancer survivors ages 26 to 39. Receipt of evidence-based survivorship care, including surveillance for cancer recurrence based on national guidelines, remain low among YA survivors. At the same time, YAs ages 26 to 39 have the highest rate of both uninsurance and underinsurance among adults in the United States. Our team's prior work demonstrated that YA cancer survivors report low understanding of their health insurance and the services it covers, which affects their ability to navigate care. Together, these issues can lead to significant access to care barriers and severe medical cost consequences for this population. This proposal addresses the urgent need to improve YA cancer survivors' health insurance literacy and decrease financial toxicity, thus improving their ability to receive recommended survivorship care. Guided by Andersen and Aday's Behavioral Model of Health Services Use, we developed and pilot-tested a 4-session virtual patient navigation intervention for YA cancer survivors that was adapted from a pilot program for childhood cancer survivors. Initial results support feasibility, acceptability, and preliminary efficacy of both of these pilot trials with YA survivors ages 26 to 39. We now propose a randomized controlled trial to test the efficacy of this program ("CHAT-S," Cancer Health insurAnce Tools with Survivors) to improve health insurance literacy, financial toxicity due to medical costs, and post-treatment surveillance for recurrence among YA cancer survivors ages 26 to 39 (up to age 45). We plan to randomize N=300 (N=200 intervention; N=100 usual care) YAs with breast, testicular, lymphoma, sarcoma, and colorectal cancer who have completed initial treatment within the past year from 14 locations in the University of Utah Healthcare (UUHC) and Intermountain Healthcare (IH) systems. UUHC and IH have many rural (20%) and Hispanic/Latinx (18%) YA cancer survivors; we will oversample these important subgroups. We will determine whether CHAT-S improves health insurance literacy and financial toxicity at 6-month follow-up (primary outcomes). Further, UUHC and IH have an integrated data infrastructure which allows us to capture electronic health records and claims data to investigate whether CHAT-S improves surveillance care for recurrence at 18-month follow-up (secondary outcome). We will explore moderators (e.g., rurality, ethnicity) of the intervention effects. Finally, to inform future dissemination, we will conduct a budget impact analysis and a short-term and long-term time horizon cost-effectiveness analysis of CHAT-S. This proposal addresses the National Cancer Institute's goal of improving the care of cancer survivors and mitigating financial toxicity. We will demonstrate that a virtual health insurance literacy intervention can improve insurance literacy, financial toxicity, and surveillance care among YA cancer survivors, and provide guidance to improving survivorship care across the United States.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHAT-S | Experimental | Behavioral: CHAT-SCHAT-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. |
| Usual Care | Placebo comparator | Behavioral: Usual CareUsual care will consist of a resource list sent by the navigator. |
Who may qualify
- Ages
- 26 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.).
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 |
|---|---|---|
| CHAT-SThe 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. | Behavioural | CHAT-S |
| Usual CareUsual 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. | Behavioural | Usual Care |
Primary outcome
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).
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).
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).
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).
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).
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).
14 secondary outcomes
Surveillance for Recurrence
Time frame: 18 months
Survivorship Care Receipt
Time frame: 18 months
Insurance Coverage
Time frame: Baseline
Insurance Coverage
Time frame: 6 months
Insurance Coverage
Time frame: 12 months
Familiarity with the Affordable Care Act and other insurance legislation
Time frame: Baseline
Familiarity with the Affordable Care Act and other insurance legislation
Time frame: 6 months
Familiarity with the Affordable Care Act and other insurance legislation
Time frame: 12 months
Feasibility of enrollment and session completion
Time frame: 6 months
Acceptability:
Time frame: 6 months
Patient Satisfaction with Interpersonal Relationship with Navigator
Time frame: 6 months
Cost related literacy
Time frame: Baseline
Cost related literacy
Time frame: 6 months
Cost related literacy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Cindy Turner, MPH contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAT-S in people with Cancer, run by University of Utah at 2 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 6 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Chevrier, BS (8018881803, amy.chevrier@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Insurance Literacy Measure (HILM) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.