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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Enhanced Usual Care | No Intervention | Enhanced usual care will consist of an online or mailed health insurance resource guide. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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-
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| MGH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27277896 | Background | 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. | |
| 32305231 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Enhanced Usual Care | Enhanced usual care will consist of an online or mailed health insurance resource guide. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)- | The EUC did not participate in the health insurance navigation so data for this measure was not collected from the EUC arm. | Posted | Mean | Standard Deviation | units on a scale | 5 month follow-up |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elyse R. Park | Massachusetts General Hospital | 6177246836 | epark@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2025 | Feb 10, 2025 | Prot_SAP_000.pdf |
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Intervention and Usual care
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|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| 31273909 | 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. |
| 29219919 | 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. |
| 23907958 | 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. |
| 30073494 | 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. |
| 21035130 | 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. |
| BG001 | Enhanced Usual Care | Enhanced usual care will consist of an online or mailed health insurance resource guide. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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-
| Posted | Mean | Standard Deviation | score on a scale | baseline and 5 month follow-up |
|
|
|
| Primary | Program Feasibility | Program feasibility is measured by the percentage of navigator participants completing all 5 intervention sessions. | The EUC did not complete sessions so data for this measure was not collected from the EUC arm. | Posted | Count of Participants | Participants | 5-month follow-up |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Enhanced Usual Care | Enhanced usual care will consist of an online or mailed health insurance resource guide. | 0 | 19 | 0 | 19 | 0 | 19 |
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