Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer (HINT)

March 4, 2023 updated by: Elyse Park, PhD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 18 years of age
  • access to a smartphone, computer, or tablet with internet access
  • currently has health insurance

Exclusion Criteria:

  • under 18 years of age
  • unable to give consent due to psychiatric or cognitive impairment
  • lack of access to a smartphone, computer, or tablet with internet access
  • does not currently have health insurance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Navigation Intervention
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.
Behavioral: Health Insurance Navigation Program
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.
No Intervention: Enhanced Usual Care
Enhanced usual care will consist of an online or mailed health insurance resource guide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acceptability of the health insurance navigation program
Time Frame: 5 month follow-up

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)
5 month follow-up
feasibility of the health insurance navigation program
Time Frame: 1-2 months follow-up
number of sessions attended by consented participants (0 sessions completed to 4 sessions completed)
1-2 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline health insurance literacy to 5-month follow-up
Time Frame: baseline and 5 month follow-up

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
baseline and 5 month follow-up
change from baseline familiarity with the ACA to 5-month follow-up
Time Frame: baseline and 5 month follow-up
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)-
baseline and 5 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

St. Jude Children's Research Hospital
University of Utah
American Cancer Society, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018P003088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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