Adolescent, Cancer, Young Adult
Conditions
Keywords
Education, Insurance
Brief 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.
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.
Interventions
\[See arm/group descriptions\]
OTHERUsual Care
\[See arm/group descriptions\]
Sponsors
Intermountain Health Care, Inc.
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Measurement | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Efficacy- Health Insurance Literacy | 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. |
| Changes in Efficacy- Affordable Care Act (ACA) Familiarity | Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks)) | 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. |
| Changes in Efficacy-Financial Distress | 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. |
Countries
United States
Participant flow
Recruitment details
We decided to overshoot our original target just to have the extra data.
Participants by arm
| Arm | Count |
|---|---|
| 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): \[See arm/group descriptions\] | 45 |
| Usual Care Participants will be randomized to receive standard navigation provided by patient navigators (usual care).
Usual Care: \[See arm/group descriptions\] | 41 |
| Total | 86 |
Baseline characteristics
| Characteristic | Usual Care | HIEP Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 45 Participants | 86 Participants |
| Age, Continuous | 28.71 Years STANDARD_DEVIATION 6.15 | 28.96 Years STANDARD_DEVIATION 7.19 | 28.84 Years STANDARD_DEVIATION 6.68 |
| Age, Customized Older Group Age 26-39 | 28 Participants | 28 Participants | 56 Participants |
| Age, Customized Younger Group Age 18-25 | 13 Participants | 17 Participants | 30 Participants |
| COmprehensive Score for financial Toxicity (COST) | 20.18 Score on a scale STANDARD_DEVIATION 12.2 | 19.72 Score on a scale STANDARD_DEVIATION 9.72 | 19.94 Score on a scale STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 39 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Health Insurance Literacy Measure (HILM) | 22.46 Score on a scale STANDARD_DEVIATION 5.81 | 22.64 Score on a scale STANDARD_DEVIATION 5.21 | 22.55 Score on a scale STANDARD_DEVIATION 5.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) White | 26 Participants | 36 Participants | 62 Participants |
| Region of Enrollment United States | 41 participants | 45 participants | 86 participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 59 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Post-Assessment interview (Weeks 18 (+/- 2 weeks))
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Acceptability - Module Satisfaction | 10 Participants |
| HIEP Intervention | Acceptability - Module Satisfaction | 0 Participants |
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.)
Time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Feasibility Measurement | 39 Participants |
| HIEP Intervention | Feasibility Measurement | 25 Participants |
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.
Time frame: Post-Assessment survey (Weeks 13 (+/- 2 weeks))
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Navigator Satisfaction | 30.84 score on a scale | Standard Deviation 16.15 |
| HIEP Intervention | Navigator Satisfaction | 30.32 score on a scale | Standard Deviation 12.95 |
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.
Time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Changes in Efficacy- Affordable Care Act (ACA) Familiarity | 5.84 Score on a scale | Standard Deviation 6.3 |
| HIEP Intervention | Changes in Efficacy- Affordable Care Act (ACA) Familiarity | 2.03 Score on a scale | Standard Deviation 4.89 |
| Combined | Changes in Efficacy- Affordable Care Act (ACA) Familiarity | 3.93 Score on a scale | Standard Deviation 5.92 |
p-value: 0.0049t-test, 2 sided
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.
Time frame: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Changes in Efficacy-Financial Distress | Older group (26-39) | 3.08 Score on a scale | Standard Deviation 8.45 |
| Usual Care | Changes in Efficacy-Financial Distress | Combined (18-39) | 3.25 Score on a scale | Standard Deviation 8.65 |
| Usual Care | Changes in Efficacy-Financial Distress | Younger group (18-25) | 3.70 Score on a scale | Standard Deviation 9.59 |
| HIEP Intervention | Changes in Efficacy-Financial Distress | Combined (18-39) | 1.28 Score on a scale | Standard Deviation 7.2 |
| HIEP Intervention | Changes in Efficacy-Financial Distress | Younger group (18-25) | 2.89 Score on a scale | Standard Deviation 9.44 |
| HIEP Intervention | Changes in Efficacy-Financial Distress | Older group (26-39) | 0.741 Score on a scale | Standard Deviation 6.42 |
| Combined | Changes in Efficacy-Financial Distress | Older group (26-39) | 1.87 Score on a scale | Standard Deviation 7.48 |
| Combined | Changes in Efficacy-Financial Distress | Younger group (18-25) | 3.32 Score on a scale | Standard Deviation 9.26 |
| Combined | Changes in Efficacy-Financial Distress | Combined (18-39) | 2.25 Score on a scale | Standard Deviation 7.95 |
p-value: 0.297t-test, 2 sided
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.
Time frame: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Changes in Efficacy- Health Insurance Literacy | 5.39 Score on a scale | Standard Deviation 6.44 |
| HIEP Intervention | Changes in Efficacy- Health Insurance Literacy | 2.30 Score on a scale | Standard Deviation 6.06 |
| Combined | Changes in Efficacy- Health Insurance Literacy | 3.84 Score on a scale | Standard Deviation 6.4 |
p-value: 0.0401t-test, 2 sided