Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors

NCT ID: NCT05002608

Last Updated: 2025-03-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-07-30

Brief Summary

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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.

Detailed Description

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With support from the American Cancer Society, Dr. Park designed a 5-session health insurance navigation treatment program, Health Insurance Navigation Tools (HINT), that is currently being delivered remotely, as a collaboration with the Childhood Cancer Survivor Study. Given the current insurance landscape and the additional insurance burden that adult colorectal cancer survivors face, the present study seeks to conduct a pilot trial with the existing health insurance intervention and adult colorectal cancer survivors seen at MGH Cancer Centers to improve health insurance literacy and decrease financial burden related to medical costs. The present study seeks to develop and pilot a health insurance navigation program with adult colorectal cancer survivors recruited from MGH. Patients diagnosed with colorectal cancer have a higher risk of experiencing financial burden related to health care costs when compared to patients diagnosed with other types of cancer. While many cancer survivors report experiencing financial burden, financial burden is particularly acute among survivors of colorectal cancer. Outcomes of financial burden among colorectal cancer survivors include lower health related quality of life, employment concerns, and delay or lack of engagement in needed surveillance and follow-up care.

Understanding and navigating insurance benefits in the current landscape is crucial for colorectal cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to develop and pilot an insurance navigation intervention to examine its feasibility and acceptability among colorectal cancer survivors receiving care at the MGH.

Conditions

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Health Insurance Colorectal Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Intervention and Usual care
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Navigation Intervention

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.

Group Type EXPERIMENTAL

Health Insurance Navigation Tools Program

Intervention Type 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.

Enhanced Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Health Insurance Navigation Tools Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elyse Park, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

MGH

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27277896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32305231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31273909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29219919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23907958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30073494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21035130 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MGH HINT Colorectal (HINT-C)

Identifier Type: -

Identifier Source: org_study_id

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