Study Summary
This trial will assess if an interactive health insurance navigation program can help childhood cancer survivors reduce worry, unmet health care needs & financial consequences of medical costs.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: 18 months follow up
12 months follow up
Change in Health Insurance Literacy from baseline to 12 months.
Change in annual out-of-pocket costs from baseline to 12 months.
Change in self-reported financial hardship from baseline to 12 months.
Change in the number of Health Care Visits and Procedures (health care utilization) from baseline to 12 months.
18 months follow up
Change in Health Insurance Literacy from baseline to 18 months.
Change in annual out-of-pocket costs from baseline to 18 months.
Change in self-reported financial hardship from baseline to 18 months.
Change in the number of Health Care Visits and Procedures (health care utilization) from baseline to 18 months.
6 months follow up
Change in Health Insurance Literacy from baseline to 6 months.
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
3 Treatment Groups
Enhanced Usual Care
1 of 3
HINT Synchronous Intervention Group (HINT-S)
1 of 3
HINT Asynchronous Intervention Group (HINT-A)
1 of 3
Active Control
Experimental Treatment
520 Total Participants · 3 Treatment Groups
Primary Treatment: HINT Synchronous Intervention Group (HINT-S) · No Placebo Group · N/A
HINT Synchronous Intervention Group (HINT-S)
Behavioral
Experimental Group · 1 Intervention: Health Insurance Navigation Tools Program · Intervention Types: BehavioralHINT Asynchronous Intervention Group (HINT-A)
Behavioral
Experimental Group · 1 Intervention: Health Insurance Navigation Tools Program · Intervention Types: BehavioralEnhanced Usual CareNoIntervention Group · 1 Intervention: Enhanced Usual Care · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months follow up
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,780 Previous Clinical Trials
31,224,453 Total Patients Enrolled
1 Trials studying Childhood Cancer Survivors
82 Patients Enrolled for Childhood Cancer Survivors
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, Green DM, Armstrong GT, Nottage KA, Jones KE, Sklar CA, Srivastava DK, Robison LL. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013 Jun 12;309(22):2371-2381. doi: 10.1001/jama.2013.6296. Erratum in: JAMA. 2013 Jul 3;310(1):99.
- Landier W, Bhatia S, Eshelman DA, Forte KJ, Sweeney T, Hester AL, Darling J, Armstrong FD, Blatt J, Constine LS, Freeman CR, Friedman DL, Green DM, Marina N, Meadows AT, Neglia JP, Oeffinger KC, Robison LL, Ruccione KS, Sklar CA, Hudson MM. Development of risk-based guidelines for pediatric cancer survivors: the Children's Oncology Group Long-Term Follow-Up Guidelines from the Children's Oncology Group Late Effects Committee and Nursing Discipline. J Clin Oncol. 2004 Dec 15;22(24):4979-90. Epub 2004 Dec 2.
- Long SK, Goin D. Large Racial and Ethnic Differences in Health Insurance Literacy Signal Need for Targeted Education and Outreach 2014. http://hrms.urban.org/briefs/literacy-by-race.html. Accessed Dec 2, 2014.
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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.
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- Ness KK, Mertens AC, Hudson MM, Wall MM, Leisenring WM, Oeffinger KC, Sklar CA, Robison LL, Gurney JG. Limitations on physical performance and daily activities among long-term survivors of childhood cancer. Ann Intern Med. 2005 Nov 1;143(9):639-47. doi: 10.7326/0003-4819-143-9-200511010-00007.
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- Langeveld NE, Grootenhuis MA, Voute PA, de Haan RJ, van den Bos C. Quality of life, self-esteem and worries in young adult survivors of childhood cancer. Psychooncology. 2004 Dec;13(12):867-81. doi: 10.1002/pon.800.
- 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.
- 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.
- Nathan PC, Henderson TO, Kirchhoff AC, Park ER, Yabroff KR. Financial Hardship and the Economic Effect of Childhood Cancer Survivorship. J Clin Oncol. 2018 Jul 20;36(21):2198-2205. doi: 10.1200/JCO.2017.76.4431. Epub 2018 Jun 6.
- Kuhlthau KA, Nipp RD, Shui A, Srichankij S, Kirchhoff AC, Galbraith AA, Park ER. Health insurance coverage, care accessibility and affordability for adult survivors of childhood cancer: a cross-sectional study of a nationally representative database. J Cancer Surviv. 2016 Dec;10(6):964-971. doi: 10.1007/s11764-016-0542-7. Epub 2016 Apr 12.
- Mueller EL, Park ER, Davis MM. What the affordable care act means for survivors of pediatric cancer. J Clin Oncol. 2014 Mar 1;32(7):615-7. doi: 10.1200/JCO.2013.52.6467. Epub 2014 Jan 6. No abstract available.
- Landier W, Bhatia S, Eshelman DA, Forte KJ, Sweeney T, Hester AL, Darling J, Armstrong FD, Blatt J, Constine LS, Freeman CR, Friedman DL, Green DM, Marina N, Meadows AT, Neglia JP, Oeffinger KC, Robison LL, Ruccione KS, Sklar CA, Hudson MM. Development of risk-based guidelines for pediatric cancer survivors: the Children's Oncology Group Long-Term Follow-Up Guidelines from the Children's Oncology Group Late Effects Committee and Nursing Discipline. J Clin Oncol. 2004 Dec 15;22(24):4979-90. doi: 10.1200/JCO.2004.11.032. Epub 2004 Dec 2.
- 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.
- 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.
- Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, Green DM, Armstrong GT, Nottage KA, Jones KE, Sklar CA, Srivastava DK, Robison LL. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013 Jun 12;309(22):2371-2381. doi: 10.1001/jama.2013.6296. Erratum In: JAMA. 2013 Jul 3;310(1):99.
- Lipshultz SE, Adams MJ, Colan SD, Constine LS, Herman EH, Hsu DT, Hudson MM, Kremer LC, Landy DC, Miller TL, Oeffinger KC, Rosenthal DN, Sable CA, Sallan SE, Singh GK, Steinberger J, Cochran TR, Wilkinson JD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Basic Cardiovascular Sciences, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiolo. Long-term cardiovascular toxicity in children, adolescents, and young adults who receive cancer therapy: pathophysiology, course, monitoring, management, prevention, and research directions: a scientific statement from the American Heart Association. Circulation. 2013 Oct 22;128(17):1927-95. doi: 10.1161/CIR.0b013e3182a88099. Epub 2013 Sep 30. No abstract available. Erratum In: Circulation. 2013 Nov 5;128(19):e394.
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- 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.
- Housten AJ, Furtado K, Kaphingst KA, Kebodeaux C, McBride T, Cusanno B, Politi MC. Stakeholders' perceptions of ways to support decisions about health insurance marketplace enrollment: a qualitative study. BMC Health Serv Res. 2016 Nov 8;16(1):634. doi: 10.1186/s12913-016-1890-8.
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- 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.
- 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.
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Frequently Asked Questions
Are there still open enrolment opportunities for this experiment?
"Affirmative. According to the details provided on clinicaltrials.gov, this medical trial is open for recruitment, with an initial posting date of May 1st 2023 and a most recent update from May 9th 2023. The study has the capacity to admit up to 520 patients across one site." - Anonymous Online Contributor
Unverified Answer
What is the maximum participant capacity for this investigation?
"That's right. According to clinicaltrials.gov, this research endeavour is currently accepting participants and has been since May 1st 2023 when it was initially posted. The study requires 520 volunteers from a single medical centre and the information was most recently updated on May 9th 2023." - Anonymous Online Contributor
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