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

NCT05527392 | Active Not Recruiting

• 1 other identifier: 2022P000176
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Cancer Survivors

Keywords

Health Insurance; Survivorship

Outcome Measures

Primary Outcomes (1)

• Change in Health Insurance Literacy from baseline to 6 months.

  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.

  6 months follow up

Secondary Outcomes (4)

• Change in Health Insurance Literacy from baseline to 12 months.

  12 months follow up

• Change in self-reported financial hardship from baseline to 12 months.

  12 months follow up

• Change in annual out-of-pocket costs from baseline to 12 months.

  12 months follow up

• Change in the number of Health Care Visits and Procedures (health care utilization) from baseline to 12 months.

  12 months follow up

Study Arms (3)

HINT Synchronous Intervention Group (HINT-S)

EXPERIMENTAL

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

Behavioral: Health Insurance Navigation Tools Program

HINT Asynchronous Intervention Group (HINT-A)

EXPERIMENTAL

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

Behavioral: Health Insurance Navigation Tools Program

Enhanced Usual Care

NO INTERVENTION

HINT Booklet

Interventions

Health Insurance Navigation Tools Program BEHAVIORAL

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.

HINT Asynchronous Intervention Group (HINT-A); HINT Synchronous Intervention Group (HINT-S)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are 18 years or older at time of enrollment
• are able to give informed consent
• have access to a smartphone, computer, or tablet with internet access
• have US based health insurance
• current LTFU cohort participants
• having access to the CCSS patient portal.

You may not qualify if:

• Participants from the pilot trial will not be eligible

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (118)

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• Emmons KM, Puleo E, Park E, Gritz ER, Butterfield RM, Weeks JC, Mertens A, Li FP. Peer-delivered smoking counseling for childhood cancer survivors increases rate of cessation: the partnership for health study. J Clin Oncol. 2005 Sep 20;23(27):6516-23. doi: 10.1200/JCO.2005.07.048. Epub 2005 Aug 22.

  PMID: 16116148 BACKGROUND

• Park ER, Puleo E, Butterfield RM, Zorn M, Mertens AC, Gritz ER, Li FP, Emmons KM. A process evaluation of a telephone-based peer-delivered smoking cessation intervention for adult survivors of childhood cancer: the partnership for health study. Prev Med. 2006 Jun;42(6):435-42. doi: 10.1016/j.ypmed.2006.03.004. Epub 2006 Apr 19.

  PMID: 16626797 BACKGROUND

• Park EB, Emmons KM, Malloy NW, Seifer E. A qualitative exploration of health perceptions and behaviors among adult survivors of childhood cancers. J Cancer Educ. 2002 Winter;17(4):211-5. doi: 10.1080/08858190209528840.

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• Butterfield RM, Park ER, Puleo E, Mertens A, Gritz ER, Li FP, Emmons K. Multiple risk behaviors among smokers in the childhood cancer survivors study cohort. Psychooncology. 2004 Sep;13(9):619-29. doi: 10.1002/pon.764.

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• Duffey-Lind EC, O'Holleran E, Healey M, Vettese M, Diller L, Park ER. Transitioning to survivorship: a pilot study. J Pediatr Oncol Nurs. 2006 Nov-Dec;23(6):335-43. doi: 10.1177/1043454206293267.

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• Earle CC, Park ER, Lai B, Weeks JC, Ayanian JZ, Block S. Identifying potential indicators of the quality of end-of-life cancer care from administrative data. J Clin Oncol. 2003 Mar 15;21(6):1133-8. doi: 10.1200/JCO.2003.03.059.

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• Wescott P.H., Reifler, E. J., Sepucha, K., Park, E. R. Breast cancer treatment decision making: Does the sisterhood of breast cancer transcend culture? Research in the Sociology of Health Care: Health Care Services, Racial and Ethnic Minorities and Underserved Populations 2005; 23.

  BACKGROUND

• Bober SL, Park ER, Schmookler T, Medeiros Nancarrow C, Diller L. Perceptions of breast cancer risk and cancer screening: a qualitative study of young, female Hodgkin's disease survivors. J Cancer Educ. 2007 Spring;22(1):42-6. doi: 10.1007/BF03174374.

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• Warner EL, Wu YP, Hacking CC, Wright J, Spraker-Perlman HL, Gardner E, Kirchhoff AC. An Assessment to Inform Pediatric Cancer Provider Development and Delivery of Survivor Care Plans. J Cancer Educ. 2015 Dec;30(4):677-84. doi: 10.1007/s13187-015-0829-9.

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• Mann K, Wu YP, Pannier ST, Hacking C, Warner EL, Rosen S, Acharya A, Wright J, Gerdy C, Kirchhoff AC. Healthcare provider perspectives on pediatric cancer survivorship care plans: a single institution pilot study. Support Care Cancer. 2021 Feb;29(2):697-706. doi: 10.1007/s00520-020-05522-w. Epub 2020 May 21.

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• Pannier ST, Mann K, Warner EL, Rosen S, Acharya A, Hacking C, Gerdy C, Wright J, Wu YP, Kirchhoff AC. Survivorship care plan experiences among childhood acute lymphoblastic leukemia patients and their families. BMC Pediatr. 2019 Apr 13;19(1):111. doi: 10.1186/s12887-019-1464-0.

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• Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4.

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• Park ER, Perez GK, Millstein RA, Luberto CM, Traeger L, Proszynski J, Chad-Friedman E, Kuhlthau KA. A Virtual Resiliency Intervention Promoting Resiliency for Parents of Children with Learning and Attentional Disabilities: A Randomized Pilot Trial. Matern Child Health J. 2020 Jan;24(1):39-53. doi: 10.1007/s10995-019-02815-3.

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• Perez GK, Walsh EA, Quain K, Abramson JS, Park ER. A virtual resiliency program for lymphoma survivors: helping survivors cope with post-treatment challenges. Psychol Health. 2021 Nov;36(11):1352-1367. doi: 10.1080/08870446.2020.1849699. Epub 2020 Nov 28.

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• Mazurek MO, Stobbe G, Loftin R, Malow BA, Agrawal MM, Tapia M, Hess A, Farmer J, Cheak-Zamora N, Kuhlthau K, Sohl K. ECHO Autism Transition: Enhancing healthcare for adolescents and young adults with autism spectrum disorder. Autism. 2020 Apr;24(3):633-644. doi: 10.1177/1362361319879616. Epub 2019 Oct 3.

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• Park ER, Sylvia LG, Streck JM, Luberto CM, Stanton AM, Perez GK, Baim M, Bliss CC, Convery MS, Crute S, Denninger JW, Donelan K, Dossett ML, Fava M, Fredriksson S, Fricchione G, George N, Hall DL, Hart BR, Herman J, Hirschberg A, Holt D, Looby SE, Malloy L, Meek J, Mehta DH, Millstein RA, Mizrach H, Rosa K, Slawsby E, Stupinski AC, Traeger L, Vanderkruik R, Vogeli C, Wilhelm S. Launching a resiliency group program to assist frontline clinicians in meeting the challenges of the COVID-19 pandemic: Results of a hospital-based systems trial. Gen Hosp Psychiatry. 2021 Jan-Feb;68:111-112. doi: 10.1016/j.genhosppsych.2020.10.005. Epub 2020 Nov 2. No abstract available.

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• DeTore N, Shannon A, Hynes S, Herman J, Perlis R, Fava M, Park ER, Sylvia L, Holt DJ. Resilience and levels of emotional distress in healthcare workers during the COVID-19 pandemic. MGH Clinical Research Day. Boston, MA. October 2021.

  BACKGROUND

• Rigotti NA, Bitton A, Kelley JK, Hoeppner BB, Levy DE, Mort E. Offering population-based tobacco treatment in a healthcare setting: a randomized controlled trial. Am J Prev Med. 2011 Nov;41(5):498-503. doi: 10.1016/j.amepre.2011.07.022.

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• Rigotti NA, Regan S, Levy DE, Japuntich S, Chang Y, Park ER, Viana JC, Kelley JH, Reyen M, Singer DE. Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):719-28. doi: 10.1001/jama.2014.9237.

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• Celano CM, Healy B, Suarez L, Levy DE, Mastromauro C, Januzzi JL, Huffman JC. Cost-Effectiveness of a Collaborative Care Depression and Anxiety Treatment Program in Patients with Acute Cardiac Illness. Value Health. 2016 Mar-Apr;19(2):185-91. doi: 10.1016/j.jval.2015.12.015. Epub 2016 Feb 6.

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• Levy DE, Klinger EV, Linder JA, Fleegler EW, Rigotti NA, Park ER, Haas JS. Cost-Effectiveness of a Health System-Based Smoking Cessation Program. Nicotine Tob Res. 2017 Nov 7;19(12):1508-1515. doi: 10.1093/ntr/ntw243.

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• Delahanty LM, Levy DE, Chang Y, Porneala BC, Goldman V, McCarthy J, Bissett L, Rodriguez AR, Chase B, LaRocca R, Wheeler A, Wexler DJ. Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. J Gen Intern Med. 2020 Sep;35(9):2637-2646. doi: 10.1007/s11606-019-05629-9. Epub 2020 Jan 21.

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• Demographics of Mobile Device Ownership and Adoption in the United States. Pew Research Center: Internet, Science & Tech. Accessed May 28, 2021.

  BACKGROUND

• https://www.pewresearch.org/fact-tank/2021/07/16/home-broadband-adoption-computer-ownership-vary-by-race-ethnicity-in-the-u-s/

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• Sinaiko AD, Hayes M, Kingsdale J, Peltz A, Galbraith AA. Understanding Consumer Experiences and Insurance Outcomes Following Plan Disenrollment in the Nongroup Insurance Market. Med Care Res Rev. 2022 Feb;79(1):36-45. doi: 10.1177/1077558721998910. Epub 2021 Mar 16.

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• Mueller EL, Park ER, Kirchhoff AC, Kuhlthau K, Nathan PC, Perez GK, Rabin J, Hutchinson R, Oeffinger KC, Robison LL, Armstrong GT, Leisenring WM, Donelan K. Insurance, chronic health conditions, and utilization of primary and specialty outpatient services: a Childhood Cancer Survivor Study report. J Cancer Surviv. 2018 Oct;12(5):639-646. doi: 10.1007/s11764-018-0700-1. Epub 2018 Jun 25.

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  BACKGROUND

• Park ER, Kirchhoff AC, Mitchell CO, Durieux N, Foor A, Kuhlthau K, Perez GK, Ards L, Alston S, Armstrong GT, Vaca Lopez PL, McDonald A, Nolan VG, Levy DE, Leisenring WM, Galbraith AA, Nathan PC, Vukadinovich C, Cooper CL, Donelan K. Assessing the effect of virtual navigation interventions to improve health insurance literacy and decrease financial burden in cancer survivors: The HINT II study protocol. Contemp Clin Trials. 2025 Jul;154:107952. doi: 10.1016/j.cct.2025.107952. Epub 2025 May 12.

  PMID: 40368025 DERIVED

Study Officials

• Elyse R Park, Ph.D., MPH

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Enhanced Usual Care HINT Synchronous Intervention Group HINT Asynchronous Intervention Group

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: September 2, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (1)