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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HINT Synchronous Intervention Group (HINT-S) | Experimental | a virtual, synchronous version of the 5 HINT-S navigator sessions + HINT booklet |
|
| HINT Asynchronous Intervention Group (HINT-A) | Experimental | a prerecorded, asynchronous version of the 5 HINT-S navigator sessions + HINT booklet |
|
| Enhanced Usual Care | No Intervention | HINT Booklet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Insurance Literacy from baseline to 12 months. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elyse R Park, Ph.D., MPH | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24304873 | Background | Robison LL, Hudson MM. Survivors of childhood and adolescent cancer: life-long risks and responsibilities. Nat Rev Cancer. 2014 Jan;14(1):61-70. doi: 10.1038/nrc3634. Epub 2013 Dec 5. | |
| 20634481 | Background | Friedman DL, Whitton J, Leisenring W, Mertens AC, Hammond S, Stovall M, Donaldson SS, Meadows AT, Robison LL, Neglia JP. Subsequent neoplasms in 5-year survivors of childhood cancer: the Childhood Cancer Survivor Study. J Natl Cancer Inst. 2010 Jul 21;102(14):1083-95. doi: 10.1093/jnci/djq238. Epub 2010 Jul 15. |
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Enhanced Usual Care HINT Synchronous Intervention Group HINT Asynchronous Intervention Group
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|
| 12 months follow up |
| Change in self-reported financial hardship from baseline to 12 months. | 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. | 12 months follow up |
| Change in annual out-of-pocket costs from baseline to 12 months. | Change in the dollar amount of out-of-pocket annual costs will be compared over time between groups. | 12 months follow up |
| Change in the number of Health Care Visits and Procedures (health care utilization) from baseline to 12 months. | 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. | 12 months follow up |
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| 19336350 | Background | Galbraith AA, Ross-Degnan D, Soumerai SB, Miroshnik I, Wharam JF, Kleinman K, Lieu TA. High-deductible health plans: are vulnerable families enrolled? Pediatrics. 2009 Apr;123(4):e589-94. doi: 10.1542/peds.2008-1738. |
| 21348554 | Background | Galbraith AA, Ross-Degnan D, Soumerai SB, Abrams AM, Kleinman K, Rosenthal MB, Wharam JF, Adams AS, Miroshnik I, Lieu TA. Use of well-child visits in high-deductible health plans. Am J Manag Care. 2010 Nov;16(11):833-40. |
| 20033623 | Background | Lieu TA, Solomon JL, Sabin JE, Kullgren JT, Hinrichsen VL, Galbraith AA. Consumer awareness and strategies among families with high-deductible health plans. J Gen Intern Med. 2010 Mar;25(3):249-54. doi: 10.1007/s11606-009-1184-5. Epub 2009 Dec 22. |
| 17356030 | Background | Wharam JF, Landon BE, Galbraith AA, Kleinman KP, Soumerai SB, Ross-Degnan D. Emergency department use and subsequent hospitalizations among members of a high-deductible health plan. JAMA. 2007 Mar 14;297(10):1093-102. doi: 10.1001/jama.297.10.1093. |
| 18458277 | Background | Wharam JF, Galbraith AA, Kleinman KP, Soumerai SB, Ross-Degnan D, Landon BE. Cancer screening before and after switching to a high-deductible health plan. Ann Intern Med. 2008 May 6;148(9):647-55. doi: 10.7326/0003-4819-148-9-200805060-00004. |
| 16116148 | Background | 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. |
| 16626797 | 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. |
| 12556058 | 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. |
| 15334530 | Background | 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. |
| 17035624 | Background | 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. |
| 12637481 | Background | 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. |
| Background | 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. |
| 17570808 | 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. |
| 25893925 | Background | 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. |
| 32435970 | Background | 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. |
| 30979365 | Background | 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. |
| 33740231 | Background | Waters AR, Mann K, Vaca Lopez PL, Kepka D, Wu YP, Kirchhoff AC. HPV Vaccine Experiences and Preferences Among Young Adult Cancer Survivors and Caregivers of Childhood Cancer Survivors. J Cancer Educ. 2022 Oct;37(5):1519-1524. doi: 10.1007/s13187-021-01992-6. Epub 2021 Mar 19. |
| 25617166 | Background | Balaban RB, Galbraith AA, Burns ME, Vialle-Valentin CE, Larochelle MR, Ross-Degnan D. A Patient Navigator Intervention to Reduce Hospital Readmissions among High-Risk Safety-Net Patients: A Randomized Controlled Trial. J Gen Intern Med. 2015 Jul;30(7):907-15. doi: 10.1007/s11606-015-3185-x. Epub 2015 Jan 24. |
| 24744082 | Background | Burns ME, Galbraith AA, Ross-Degnan D, Balaban RB. Feasibility and evaluation of a pilot community health worker intervention to reduce hospital readmissions. Int J Qual Health Care. 2014 Aug;26(4):358-65. doi: 10.1093/intqhc/mzu046. Epub 2014 Apr 16. |
| 20607432 | Background | Donelan K, Mailhot JR, Dutwin D, Barnicle K, Oo SA, Hobrecker K, Percac-Lima S, Chabner BA. Patient perspectives of clinical care and patient navigation in follow-up of abnormal mammography. J Gen Intern Med. 2011 Feb;26(2):116-22. doi: 10.1007/s11606-010-1436-4. Epub 2010 Jul 7. |
| 30900195 | Background | 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. |
| 31650412 | Background | 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. |
| 33251861 | Background | 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. |
| 31581793 | Background | 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. |
| 33229013 | Background | 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. |
| 34857369 | Background | DeTore NR, Sylvia L, Park ER, Burke A, Levison JH, Shannon A, Choi KW, Jain FA, Coman DC, Herman J, Perlis R, Fava M, Holt DJ. Promoting resilience in healthcare workers during the COVID-19 pandemic with a brief online intervention. J Psychiatr Res. 2022 Feb;146:228-233. doi: 10.1016/j.jpsychires.2021.11.011. Epub 2021 Nov 7. |
| 22011421 | 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. |
| 25138333 | Background | 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. |
| 26260043 | Background | Delahanty LM, Dalton KM, Porneala B, Chang Y, Goldman VM, Levy D, Nathan DM, Wexler DJ. Improving diabetes outcomes through lifestyle change--A randomized controlled trial. Obesity (Silver Spring). 2015 Sep;23(9):1792-9. doi: 10.1002/oby.21172. Epub 2015 Aug 11. |
| 26671700 | Background | Levy DE, Munshi VN, Ashburner JM, Zai AH, Grant RW, Atlas SJ. Health IT-assisted population-based preventive cancer screening: a cost analysis. Am J Manag Care. 2015 Dec;21(12):885-91. |
| 27021752 | Background | 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. |
| 27639095 | Background | 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. |
| 31965526 | Background | 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. |
| 33792730 | Background | Drouin O, Sato R, Drehmer JE, Nabi-Burza E, Hipple Walters B, Winickoff JP, Levy DE. Cost-effectiveness of a Smoking Cessation Intervention for Parents in Pediatric Primary Care. JAMA Netw Open. 2021 Apr 1;4(4):e213927. doi: 10.1001/jamanetworkopen.2021.3927. |
| 27754926 | Background | Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer Survivors: A Systematic Review. J Natl Cancer Inst. 2016 Oct 20;109(2):djw205. doi: 10.1093/jnci/djw205. Print 2017 Feb. |
| 27716900 | Background | de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7. |
| Background | Levy H, Meltzer D. What Do We Really Know About Whether Health Insura.pdf. Accessed July 23, 2021. https://web.stanford.edu/~jay/health_class/Readings/Lecture02/levy_meltzer.pdf |
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| Background | 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/ |
| 27253866 | Background | Bhatia S, Gibson TM, Ness KK, Liu Q, Oeffinger KC, Krull KR, Nathan PC, Neglia JP, Leisenring W, Yasui Y, Robison LL, Armstrong GT. Childhood cancer survivorship research in minority populations: A position paper from the Childhood Cancer Survivor Study. Cancer. 2016 Aug 1;122(15):2426-39. doi: 10.1002/cncr.30072. Epub 2016 Jun 2. |
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| Background | Holahan J, Long S. Health Reform Monitoring Survey, first quarter 2016 [Internet]. Ann Arbor (MI): Inter-university Consortium for Political and Social Research [distributor]; 2017 Apr 28 [cited 2019 Jan 31]. Available from: https://www.icpsr.umich.edu/icpsrweb/HMCA/studies/36744/version/1 |
| 33724071 | Background | 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. |
| 30830810 | Background | Hero JO, Sinaiko AD, Kingsdale J, Gruver RS, Galbraith AA. Decision-Making Experiences Of Consumers Choosing Individual-Market Health Insurance Plans. Health Aff (Millwood). 2019 Mar;38(3):464-472. doi: 10.1377/hlthaff.2018.05036. |
| 31044413 | Background | Yabroff KR, Zhao J, Han X, Zheng Z. Prevalence and Correlates of Medical Financial Hardship in the USA. J Gen Intern Med. 2019 Aug;34(8):1494-1502. doi: 10.1007/s11606-019-05002-w. Epub 2019 May 1. |
| 6668417 | Background | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| 29943170 | Background | 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. |
| 22180128 | Background | Kurt BA, Nolan VG, Ness KK, Neglia JP, Tersak JM, Hudson MM, Armstrong GT, Hutchinson RJ, Leisenring WM, Oeffinger KC, Robison LL, Arora M. Hospitalization rates among survivors of childhood cancer in the Childhood Cancer Survivor Study cohort. Pediatr Blood Cancer. 2012 Jul 15;59(1):126-32. doi: 10.1002/pbc.24017. Epub 2011 Dec 16. |
| 20957426 | Background | Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. |
| Background | Overview of BLS Wage Data by Area and Occupation : U.S. Bureau of Labor Statistics. Accessed July 22, 2021. https://www.bls.gov/bls/blswage.htm |
| 40368025 | Derived | 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. |