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NCT04520061: HINT

Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer

Completed NA Results posted Last updated 3 February 2025
What this trial tests

NA trial testing Health Insurance Navigation Program in Health Insurance in 82 participants. Completed in 31 December 2022.

Timeline
25 August 2020
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorMassachusetts General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment82
Start date25 August 2020
Primary completion31 December 2022
Estimated completion31 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Health Insurance or Childhood Cancer Survivors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability of the Health Insurance Navigation Program Primary · 5 month follow-up

10-point (1-10; 1= least helpful and 10= most helpful) 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)

GroupValue95% CI
Navigation Intervention8.9± 1.2
Percentage of Participants Completing All 4 Intervention Sessions Primary · 1-2 months follow-up

Program feasibility is measured by the percentage of participants completing all 4 intervention sessions.

GroupValue95% CI
Navigation Intervention33
Change From Baseline Familiarity With ACA Provisions to 5-month Follow-up Secondary · baseline and 5 month follow-up

6 items rating familiarity with key Affordable Care Act (ACA) protections (scores range from 0-6; higher scores indicate higher degree of familiarity) (scale adapted from CCSS Health Insurance Survey)

GroupValue95% CI
Navigation Intervention1.7± 1.7
Enhanced Usual Care0.5± 1.6
Change From Baseline Health Insurance Literacy to 5-month Follow-up Secondary · baseline and 5 month follow-up

16 items with a 4-category Likert scale ranging from 16-64 (higher scores denoting lower literacy) of confidence on understanding of health insurance terms (higher scores indicate higher levels of health insurance literacy). We report mean health insurance literacy change from baseline to follow-up. Scale adapted from the Urban Institute Health Reform Monitoring Survey- * premium * deductible * co-payments * co-insurance

GroupValue95% CI
Navigation Intervention9.1± 7.6
Enhanced Usual Care1.8± 7.9

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Navigating financial toxicity in patients with cancer: A multidisciplinary management approach.
    Smith GL, Banegas MP, Acquati C, Chang S, et al · · 2022 · cited 193× · PMID 35584404 · DOI 10.3322/caac.21730
  2. Health Insurance Navigation Tools Intervention: A Pilot Trial Within the Childhood Cancer Survivor Study.
    Park ER, Kirchhoff AC, Donelan K, Perez GK, et al · · 2024 · cited 18× · PMID 38471048 · DOI 10.1200/op.23.00680
  3. CHAT-S Study Protocol: A randomized controlled trial of a health insurance literacy education program for young adult cancer survivors.
    Killela M, Turner CA, Chevrier A, Stefanou M, et al · · 2025 · cited 2× · PMID 40821005 · DOI 10.1080/28322134.2025.2455706
  4. Editorial: Financial anxiety in cancer prevention and control.
    Parsons HM, Banegas MP, Bar-Sela G, Jones SM. · · 2023 · PMID 37908816 · DOI 10.3389/fpsyg.2023.1304079

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing