Behaviors and Mental Disorders

All Conditions

Financial Stress

a virtual, synchronous version of the 5 HINT-S navigator sessions + HINT booklet

a prerecorded, asynchronous version of the 5 HINT-S navigator sessions + HINT booklet

The program will be delivered via videoconferencing by a navigator over approximately a 3-month period and will consist of 5 sessions. The navigation intervention sessions will be as follows: Section 1- Insurance Plan Basics; Section 2- Your Plan in Relation to Policy; Section 3- Navigating Your Plan and Overcoming Obstacles; Section 4- Managing Care Costs; 5-Understanding Your Medical Bills.

Health Insurance Navigation Tools Program

Elyse R Park, PhD

Anne Kirchhoff, PhD

Elyse Park, PhD

The investigators are conducting a Type I hybrid effectiveness-implementation trial to assess the effectiveness of HINT-S (synchronous) compared to enhanced usual care (EUC) in promoting health insurance literacy, thus reducing worry, unmet health care needs, and financial consequences due to medical costs to improve care and long-term outcomes of childhood cancer survivors. The investigators will also compare HINT-S to HINT-A (asynchronous), a prerecorded, asynchronous version of the 5 HINT-S navigator sessions.

The present study seeks to evaluate a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort. Childhood cancer survivors face health challenges throughout their lives that require monitoring and ongoing care. This is compounded by the tendency among childhood survivors to have higher rates of underinsurance, unmet healthcare needs, and burdensome costs related to care. These burdensome costs also contribute to underutilization of care among survivors. Dr. Park and her colleagues published findings that suggested LTFU survivors had difficulty in understanding how to use their insurance, and often experienced financial-related distress. Understanding and navigating insurance benefits in the current landscape is crucial for cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to evaluate the effectiveness of an insurance navigation intervention with LTFU participants, delivered in a synchronous and asynchronous modality.

The navigation intervention will be delivered by a health insurance navigator via HIPAA-compliant videoconferencing for the synchronous group (HINT-S) and will be delivered via pre-recorded video session for the asynchronous group HINT-A). Participants will be randomized into either the two navigation intervention arms (HINT-S and HINT-A; approximately 234 per intervention arm), or the enhanced usual care arm (approximately 52 for control arm). The sample size per arm was chosen to enable evaluation of feasibility and acceptability goals, as well as to explore meaningful differences in the outcomes. To assess the proposed primary and secondary outcomes, all trial participants will complete a baseline and 6-month and 12-month post-program follow-up survey.

Enhanced Usual Care HINT Synchronous Intervention Group HINT Asynchronous Intervention Group

Virtual Health Insurance Navigation Pilot Program for Childhood Survivors (HINTII)

Assessing the Effect of Virtual Navigation Interventions to Improve Health Insurance Literacy and Decrease Financial Burden: A Childhood Cancer Survivor Study Randomized Trial (HINTII)

Change in Health Insurance Literacy, measured with the validated survey (Health Insurance Literacy scale; HIL), will be compared between groups. The HIL is a 16-item measure of participants' self-reported confidence in understanding of terms (e.g., deductible, co-payments, co-insurance) and confidence in knowing how to do health insurance-related activity (e.g. figuring out co-payments, finding an in-network doctor). Items are rated on a 4-point Likert scale with a total scale score ranging from 16-64; higher scores denote lower literacy.

Change in Health Insurance Literacy, measured with the validated survey (Health Insurance Literacy scale; HIL), will be compared over time between groups. The HIL is a 16-item measure of participants' self-reported confidence in understanding of terms (e.g., deductible, co-payments, co-insurance) and confidence in knowing how to do health insurance-related activity (e.g. figuring out co-payments, finding an in-network doctor). Items are rated on a 4-point Likert scale with a total scale score ranging from 16-64; higher scores denote lower literacy.

Change in self-reported financial hardship across time will be compared between groups and measured using 3 scales that tap into 3 domains of financial hardship: a) Behavioral, which assesses unmet health care needs due to health care costs in the past year with 8 yes/no items; more yes scores = more hardship; b) Psychological, which assess worry due to health care costs in the past year with 6-items measured on a 5 point likert; higher score reflects greater worry; c) Material, which assesses the financial consequences of health care cost in the past year with 8 yes/no items; more yes scores = more hardship.

Change in the dollar amount of out-of-pocket annual costs will be compared over time between groups.

Change in patients healthcare utilization across time will be compared over time between groups.

Health care utilization will be assessed with 11 items which ask patients to report yes/no to health care visits (e.g., any primary care visits in the past year, usual place of care, receipt of annual vaccinations. A greater number of Yes responses reflects more healthcare use.

Massachusetts General Hospital

Professor

Neoplasms

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The intervention will be delivered via synchronous videoconferencing (real-time delivery and communication between the navigator and the participant) by a trained patient navigator and will consist of 5, 30-minute sessions delivered every week. The navigation intervention group will also receive an online or mailed copy of the health insurance resource guide.

Enhanced usual care will consist of an online or mailed health insurance resource guide.

The program will be delivered via videoconferencing by a navigator over a 3-month period and will consist of 5 sessions. The navigation intervention sessions will be as follows: Session 1- Insurance Plan Basics; Session 2- Your Plan in Relation to Legal Policy; Session 3- Navigating Your Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs; Session 5- Understanding Your Medical Bills.

Elyse R Park, Ph.D.

This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve 1) health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.

With support from the American Cancer Society, Dr. Park designed a 5-session health insurance navigation treatment program, Health Insurance Navigation Tools (HINT), that is currently being delivered remotely, as a collaboration with the Childhood Cancer Survivor Study. Given the current insurance landscape and the additional insurance burden that adult colorectal cancer survivors face, the present study seeks to conduct a pilot trial with the existing health insurance intervention and adult colorectal cancer survivors seen at MGH Cancer Centers to improve health insurance literacy and decrease financial burden related to medical costs. The present study seeks to develop and pilot a health insurance navigation program with adult colorectal cancer survivors recruited from MGH. Patients diagnosed with colorectal cancer have a higher risk of experiencing financial burden related to health care costs when compared to patients diagnosed with other types of cancer. While many cancer survivors report experiencing financial burden, financial burden is particularly acute among survivors of colorectal cancer. Outcomes of financial burden among colorectal cancer survivors include lower health related quality of life, employment concerns, and delay or lack of engagement in needed surveillance and follow-up care.

Understanding and navigating insurance benefits in the current landscape is crucial for colorectal cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to develop and pilot an insurance navigation intervention to examine its feasibility and acceptability among colorectal cancer survivors receiving care at the MGH.

Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors

A Virtual Health Insurance Navigation for Colorectal Survivors

5-point (1-5) scale rating of program quality, including the following (higher scores indicate higher levels of acceptability)-

program materials scheduling communication with navigator length and number of sessions (investigator created scale)

4-point (1-4) scale rating of confidence on understanding of health insurance terms (higher scores indicate higher levels of health insurance literacy) (scale adapted from the Urban Institute Health Reform Monitoring Survey-

premium deductible co-payments co-insurance

The I Can PIC website will be provided to participants randomized to the experimental/intervention group.

Participants randomized to the attention control group will be provided a link to a website developed by the American Cancer Society Cancer Action Network.

Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.

I Can PIC

Mary C Politi, PhD

The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.

In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors. The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance. In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants. The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network. Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences. The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.

Improving Cancer Patients' Insurance Choices

Supporting Cancer Survivors' Health Insurance Marketplace Decisions

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions).

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

Participants will be asked what health insurance plan they would choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

Participants will be asked what health insurance plan they choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization

The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.

This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.

American Cancer Society, Inc.

Washington University School of Medicine

The intervention will be delivered via synchronous videoconferencing (real-time delivery and communication between the navigator and the participant) by a trained patient navigator and will consist of 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.

The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.

Health Insurance Navigation Program

Dr. Park and her colleagues published findings in the Journal of Clinical Oncology demonstrating that CCSS survivors, compared to siblings, were significantly more likely to be uninsured and to have difficulties obtaining health insurance. Given the current insurance landscape and the additional insurance burden that childhood cancer survivors face, the present study seeks to develop and pilot a health insurance navigation program targeted at feasibility and acceptability with survivors, and improving health insurance literacy and ameliorating financial distress related to medical costs. The proposed health insurance navigation will involve 4 navigator-led health insurance navigation sessions. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.

The present study seeks to develop and pilot a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort. Childhood cancer survivors tend to face health challenges throughout their lives that require monitoring and ongoing care. This is compounded by the tendency among childhood survivors to have higher rates of under and uninsurance, unmet healthcare need, and burdensome costs related to care.These burdensome costs also contribute to underutilization of care among survivors. Additionally, as health insurance systems and designs continue to evolve, many people have inadequate understandings of their own health insurance. Dr. Park and her colleagues published findings that suggested LTFU survivors had difficulty in understanding how to use their insurance, and often experienced financial-related distress. Survivors were more likely than their siblings to have borrowed money to pay for medical expenses, and only 27.3% of survivors and 26.2% of their siblings reported familiarity with the ACA. Given these circumstances, understanding and navigating insurance benefits in the current in the current landscape is crucial for cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to develop and pilot an insurance navigation intervention with LTFU participants.

The three institutions involved in this study have differing, complementary roles that will contribute to the development and piloting of a health insurance navigation intervention. As the lead site and IRB of record for this study, Massachusetts General Hospital (MGH) will be responsible for the development and regulation of all study-related materials. MGH will also be responsible for the delivery of the navigation intervention (which necessitates the training and supervision of the individual delivery the navigation).

As a collaborating site for this study, St. Jude Children's Research Hospital will be responsible for all recruitment activities, as this study plans to recruit exclusively from the Long-Term Follow-Up Study (LTFU) Cohort.

As a collaborating site for this study, the University of Utah will be responsible for all participant assessment during the study, which will include baseline and follow-up surveys, and exit interviews.

Approximately 80 LTFU participants will be recruited for the randomized pilot trial portion of the study. Prospective participants for the pilot randomized trial portion of the study will be identified via LTFU records, and recruited and consented by LTFU study staff at St. Jude Children's Research Hospital. Prospective participants will receive an invitation to the study through email and mail. The proposed navigation intervention will be delivered by a health insurance navigator via HIPAA-compliant videoconferencing. Content of the navigation intervention will involve the following sessions: 1- Learning Abut Survivorship Healthcare Needs; 2- Learning About Your Plan in Relation to Policy; 3- Navigating One's Own Plan and Overcoming Obstacles; 4- Managing Care Costs. The sessions will be delivered to participants every week over a one to two-month period. Participants will be randomized into either the navigation intervention arm, or the enhanced usual care arm (approximately 40 per arm). The sample size of approximately 40 per arm was chosen to enable evaluation of feasibility and acceptability goals, as well as to explore meaningful differences in the outcomes.To assess the proposed primary and secondary outcomes, all trial participants will complete a baseline and 3-month post-program follow-up survey (approximately 5-month follow-up from baseline). The surveys will be conducted via RedCap or via mailed survey (which will then be input into the RedCap database by study staff). Intervention arm participants will also complete an exit interview in order to further refine the navigation intervention. Both study arm participants will receive a health insurance information guide.

Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer

We will not make individual participant data available to any researchers outside of those approved to work on the study under the central IRB.

5-point (1-5) scale rating of program quality, including the following (higher scores indicate higher levels of acceptability)-

* program materials
* scheduling
* communication with navigator
* length and number of sessions (investigator created scale)

number of sessions attended by consented participants (0 sessions completed to 4 sessions completed)

4-point (1-4) scale rating of familiarity with the Affordable Care Act (ACA) (higher scores indicate higher degree of familiarity) (scale adapted from CCSS Health Insurance Survey)-

4-point (1-4) scale rating of confidence on understanding of health insurance terms (higher scores indicate higher levels of health insurance literacy) (scale adapted from the Urban Institute Health Reform Monitoring Survey-

* premium
* deductible
* co-payments
* co-insurance

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Virtual Health Insurance Navigation Pilot Program for Childhood Survivors (HINTII)	NCT05527392	Childhood Cance...	Health Insuranc...	18 Years -	Massachusetts General Hospital
Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors	NCT05002608	Health Insuranc... Colorectal Canc...	Health Insuranc...	18 Years - 65 Years	Massachusetts General Hospital
Improving Cancer Patients' Insurance Choices	NCT03592433	Cancer Health Literacy Health Insuranc... Health Services... Informed Decisi...	I Can PIC	18 Years - 64 Years	Washington University School of Medicine
Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer	NCT04520061	Health Insuranc... Childhood Cance...	Health Insuranc...	18 Years -	Massachusetts General Hospital
Improving Cancer Patients' Insurance Choices	NCT03592433	Cancer Health Literacy Health Insuranc... Health Services... Informed Decisi...	I Can PIC	18 Years - 64 Years	Washington University School of Medicine
Virtual Health Insurance Navigation Pilot Program for Childhood Survivors (HINTII)	NCT05527392	Childhood Cance...	Health Insuranc...	18 Years -	Massachusetts General Hospital

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