Health InsuranceHINT-CNCT05002608
Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors
A study testing Health Insurance Navigation Tools Program in people with Health Insurance and Colorectal Cancer Survivors, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Health Insurance, Colorectal Cancer Survivors
- What is being tested?
- Health Insurance Navigation Tools Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
MGH
Boston, Massachusetts, 02114
About this study
Official title: A Virtual Health Insurance Navigation for Colorectal Survivors
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.
Read the detailed description
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
- Health Insurance, Colorectal Cancer Survivors
- Being tested
- Health Insurance Navigation Tools Program
- Keywords
- survivorship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Insurance Navigation Tools ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)-
Measured: 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
Measured: baseline and 5 month follow-up
Program Feasibility
Program feasibility is measured by the percentage of navigator participants completing all 5 intervention sessions.
Measured: 5-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Nov 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Health InsuranceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Intervention and Usual care
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elyse Park, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002608
- Sponsor's protocol ID
- MGH HINT Colorectal (HINT-C)
- Acronym
- HINT-C
- Status last verified
- Mar 2025
- First submitted
- 9 Aug 2021
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27277896Rice 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.
PubMed 32305231Blum-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.
PubMed 31273909Sharp 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.
PubMed 29219919Kent 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.
PubMed 23907958Ford 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.
PubMed 30073494Leon 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.
PubMed 21035130
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Health Insurance Navigation for Colorectal Survivors
- ClinicalTrials.gov ID
- NCT05002608
- Acronym / sponsor ID
- HINT-C / MGH HINT Colorectal (HINT-C)
- Conditions
- Health Insurance, Colorectal Cancer Survivors
- Keywords
- survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and Usual care
| Arm | Type | Receives |
|---|---|---|
| Navigation Intervention | Experimental | Behavioral: Health Insurance Navigation Tools ProgramThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Insurance Navigation Tools ProgramThe 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. | Behavioural | Navigation Intervention |
Primary outcome
Acceptability of the Health Insurance Navigation Program
Time frame: 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)-
Change From Baseline Health Insurance Literacy to 5-month Follow-up
Time frame: 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
Program Feasibility
Time frame: 5-month follow-up
Program feasibility is measured by the percentage of navigator participants completing all 5 intervention sessions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27277896Nekhlyudov 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.
- Background: PubMed 32305231Rice 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.
- Background: PubMed 31273909Blum-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.
- Background: PubMed 29219919Sharp 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.
- Background: PubMed 23907958Kent 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.
- Background: PubMed 30073494Ford 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.
- Background: PubMed 21035130Leon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Insurance Navigation Tools Program in people with Health Insurance and Colorectal Cancer Survivors, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Health Insurance Navigation Program (time frame: 5 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002608, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.