Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors

NCT05002608 | Completed Results

• 1 other identifier: MGH HINT Colorectal (HINT-C)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve 1) health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. 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 HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.

Conditions

Health Insurance; Colorectal Cancer Survivors

Keywords

survivorship

Outcome Measures

Primary Outcomes (3)

• 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)-

  5 month follow-up

• Change From Baseline Health Insurance Literacy to 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

  baseline and 5 month follow-up

• Program Feasibility

  Program feasibility is measured by the percentage of navigator participants completing all 5 intervention sessions.

  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 5, 30-minute sessions delivered every week. The navigation intervention group will also receive an online or mailed copy of the health insurance resource guide.

Behavioral: Health Insurance Navigation Tools Program

Enhanced Usual Care

NO INTERVENTION

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

Interventions

Health Insurance Navigation Tools Program BEHAVIORAL

The program will be delivered via videoconferencing by a navigator over a 3-month period and will consist of 5 sessions. The navigation intervention sessions will be as follows: Session 1- Insurance Plan Basics; Session 2- Your Plan in Relation to Legal Policy; Session 3- Navigating Your Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs; Session 5- Understanding Your Medical Bills.

Navigation Intervention

Eligibility Criteria

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

You may qualify if:

• patients who are18-65 years of age
• patients who are 1) approximately 6 months to 5 years posttreatment for stages I-III colon or rectal cancer or 2) approximately more than 3 months post-diagnosis for stage IV colon or rectal cancer at the time of screening
• patients who had a medical visit at MGH in the past two years
• patients who have medical insurance
• patients who speak English
• patients who have access to an iPad, computer, smartphone or laptop with WIFI access

You may not qualify if:

• patients who are younger than 18 years of age or older than 65 years of age
• patients who are unable to give consent due to psychiatric or cognitive impairment
• patients who lack of access to a smartphone, computer, or tablet with internet access
• patients who do not currently have health insurance

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MGH

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

• Nekhlyudov L, Walker R, Ziebell R, Rabin B, Nutt S, Chubak J. Cancer survivors' experiences with insurance, finances, and employment: results from a multisite study. J Cancer Surviv. 2016 Dec;10(6):1104-1111. doi: 10.1007/s11764-016-0554-3. Epub 2016 Jun 9.

  PMID: 27277896 BACKGROUND

• Rice DR, Farooq A, Hyer JM, Paredes AZ, Bae J, Tsilimigras DI, Pawlik TM. Health expenditures and financial burden among patients with major gastrointestinal cancers relative to other common cancers in the United States. Surgery. 2020 Jun;167(6):985-990. doi: 10.1016/j.surg.2020.02.029. Epub 2020 Apr 15.

  PMID: 32305231 BACKGROUND

• Blum-Barnett E, Madrid S, Burnett-Hartman A, Mueller SR, McMullen CK, Dwyer A, Feigelson HS. Financial burden and quality of life among early-onset colorectal cancer survivors: A qualitative analysis. Health Expect. 2019 Oct;22(5):1050-1057. doi: 10.1111/hex.12919. Epub 2019 Jul 5.

  PMID: 31273909 BACKGROUND

• Sharp L, O'Leary E, O'Ceilleachair A, Skally M, Hanly P. Financial Impact of Colorectal Cancer and Its Consequences: Associations Between Cancer-Related Financial Stress and Strain and Health-Related Quality of Life. Dis Colon Rectum. 2018 Jan;61(1):27-35. doi: 10.1097/DCR.0000000000000923.

  PMID: 29219919 BACKGROUND

• Kent EE, Forsythe LP, Yabroff KR, Weaver KE, de Moor JS, Rodriguez JL, Rowland JH. Are survivors who report cancer-related financial problems more likely to forgo or delay medical care? Cancer. 2013 Oct 15;119(20):3710-7. doi: 10.1002/cncr.28262. Epub 2013 Jul 31.

  PMID: 23907958 BACKGROUND

• Ford ME, Sterba KR, Armeson K, Malek AM, Knight KD, Zapka J. Factors Influencing Adherence to Recommended Colorectal Cancer Surveillance: Experiences and Behaviors of Colorectal Cancer Survivors. J Cancer Educ. 2019 Oct;34(5):938-949. doi: 10.1007/s13187-018-1398-5.

  PMID: 30073494 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: Elyse R. Park
• Organization: Massachusetts General Hospital

epark@mgh.harvard.edu

6177246836

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention and Usual care

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 12, 2021
• Study Start: November 1, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)