Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer

NCT04520061 | Completed Results

• 1 other identifier: 2018P003088
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Insurance; Childhood Cancer Survivors

Keywords

survivorship

Outcome Measures

Primary Outcomes (2)

• Acceptability of the Health Insurance Navigation Program

  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)

  5 month follow-up

• Percentage of Participants Completing All 4 Intervention Sessions

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

  1-2 months follow-up

Secondary Outcomes (2)

• Change From Baseline Familiarity With ACA Provisions to 5-month Follow-up

  baseline and 5 month follow-up

• Change From Baseline Health Insurance Literacy to 5-month Follow-up

  baseline and 5 month follow-up

Study Arms (2)

Navigation Intervention

EXPERIMENTAL

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

Enhanced Usual Care

NO INTERVENTION

Enhanced usual care will consist of an online or mailed health insurance resource guide.

Interventions

Health Insurance Navigation Program BEHAVIORAL

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.

Navigation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator
• St. Jude Children's Research Hospital: collaborator
• University of Utah: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (10)

• Park ER, Li FP, Liu Y, Emmons KM, Ablin A, Robison LL, Mertens AC; Childhood Cancer Survivor Study. Health insurance coverage in survivors of childhood cancer: the Childhood Cancer Survivor Study. J Clin Oncol. 2005 Dec 20;23(36):9187-97. doi: 10.1200/JCO.2005.01.7418.

  PMID: 16361621 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.

  PMID: 24304873 BACKGROUND

• Park ER, Kirchhoff AC, Zallen JP, Weissman JS, Pajolek H, Mertens AC, Armstrong GT, Robison LL, Donelan K, Recklitis CJ, Diller LR, Kuhlthau KA. Childhood Cancer Survivor Study participants' perceptions and knowledge of health insurance coverage: implications for the Affordable Care Act. J Cancer Surviv. 2012 Sep;6(3):251-9. doi: 10.1007/s11764-012-0225-y. Epub 2012 May 17.

  PMID: 22592507 BACKGROUND

• Oeffinger KC, Mertens AC, Hudson MM, Gurney JG, Casillas J, Chen H, Whitton J, Yeazel M, Yasui Y, Robison LL. Health care of young adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Ann Fam Med. 2004 Jan-Feb;2(1):61-70. doi: 10.1370/afm.26.

  PMID: 15053285 BACKGROUND

• Yeazel MW, Oeffinger KC, Gurney JG, Mertens AC, Hudson MM, Emmons KM, Chen H, Robison LL. The cancer screening practices of adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2004 Feb 1;100(3):631-40. doi: 10.1002/cncr.20008.

  PMID: 14745882 BACKGROUND

• Casillas J, Castellino SM, Hudson MM, Mertens AC, Lima IS, Liu Q, Zeltzer LK, Yasui Y, Robison LL, Oeffinger KC. Impact of insurance type on survivor-focused and general preventive health care utilization in adult survivors of childhood cancer: the Childhood Cancer Survivor Study (CCSS). Cancer. 2011 May 1;117(9):1966-75. doi: 10.1002/cncr.25688. Epub 2010 Nov 10.

  PMID: 21509774 BACKGROUND

• Keegan TH, Tao L, DeRouen MC, Wu XC, Prasad P, Lynch CF, Shnorhavorian M, Zebrack BJ, Chu R, Harlan LC, Smith AW, Parsons HM; AYA HOPE Study Collaborative Group. Medical care in adolescents and young adult cancer survivors: what are the biggest access-related barriers? J Cancer Surviv. 2014 Jun;8(2):282-92. doi: 10.1007/s11764-013-0332-4. Epub 2014 Jan 10.

  PMID: 24408440 BACKGROUND

• Kirchhoff AC, Lyles CR, Fluchel M, Wright J, Leisenring W. Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. Cancer. 2012 Dec 1;118(23):5964-72. doi: 10.1002/cncr.27537. Epub 2012 Sep 24.

  PMID: 23007632 BACKGROUND

• Mulrooney DA, Yeazel MW, Kawashima T, Mertens AC, Mitby P, Stovall M, Donaldson SS, Green DM, Sklar CA, Robison LL, Leisenring WM. Cardiac outcomes in a cohort of adult survivors of childhood and adolescent cancer: retrospective analysis of the Childhood Cancer Survivor Study cohort. BMJ. 2009 Dec 8;339:b4606. doi: 10.1136/bmj.b4606.

  PMID: 19996459 BACKGROUND

• Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.

  PMID: 21035130 BACKGROUND

Results Point of Contact

• Title: Lisa Morse
• Organization: Mass General Hospital

lgmorse@partners.org

617-724-2000

Study Officials

• Elyse R Park, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor

Model Details: Intervention; enhanced usual care

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: August 25, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)