search
Back to results

Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors (HINT-C)

Primary Purpose

Health Insurance, Colorectal Cancer Survivors

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Insurance Navigation Tools Program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Health Insurance focused on measuring survivorship

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients who are18-65 years of age
  • patients who are 12-24 months post-treatment for stages I-III colon or rectal cancer
  • 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

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • MGHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Navigation Intervention

Enhanced Usual Care

Arm Description

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

Outcomes

Primary Outcome Measures

feasibility and acceptability of the health insurance navigation program
5-point (1-5) 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)
change from baseline health insurance literacy to 5-month follow-up
4-point (1-4) scale rating of confidence on understanding of health insurance terms (higher scores indicate higher levels of health insurance literacy) (scale adapted from the Urban Institute Health Reform Monitoring Survey- premium deductible co-payments co-insurance

Secondary Outcome Measures

Full Information

First Posted
August 9, 2021
Last Updated
March 31, 2023
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05002608
Brief Title
Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors
Acronym
HINT-C
Official Title
A Virtual Health Insurance Navigation for Colorectal Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Insurance, Colorectal Cancer Survivors
Keywords
survivorship

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention and Usual care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Navigation Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
Enhanced usual care will consist of an online or mailed health insurance resource guide.
Intervention Type
Behavioral
Intervention Name(s)
Health Insurance Navigation Tools Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
feasibility and acceptability of the health insurance navigation program
Description
5-point (1-5) 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)
Time Frame
5 month follow-up
Title
change from baseline health insurance literacy to 5-month follow-up
Description
4-point (1-4) scale rating of confidence on understanding of health insurance terms (higher scores indicate higher levels of health insurance literacy) (scale adapted from the Urban Institute Health Reform Monitoring Survey- premium deductible co-payments co-insurance
Time Frame
baseline and 5 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elyse R Park, Ph.D.
Phone
617-724-6836
Email
epark@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyse R Park, Ph.D.
Phone
617-724-6836
Email
epark@mgh.harvard.edu
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27277896
Citation
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.
Results Reference
background
PubMed Identifier
32305231
Citation
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.
Results Reference
background
PubMed Identifier
31273909
Citation
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.
Results Reference
background
PubMed Identifier
29219919
Citation
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.
Results Reference
background
PubMed Identifier
23907958
Citation
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.
Results Reference
background
PubMed Identifier
30073494
Citation
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.
Results Reference
background
PubMed Identifier
21035130
Citation
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.
Results Reference
background

Learn more about this trial

Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors

We'll reach out to this number within 24 hrs