Colorectal Cancer Survivors, Health Insurance
Conditions
Keywords
survivorship
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.
Interventions
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Intervention and Usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Health Insurance Navigation Program | 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 | 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 | 5-month follow-up | Program feasibility is measured by the percentage of navigator participants completing all 5 intervention sessions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Enhanced Usual Care Enhanced usual care will consist of an online or mailed health insurance resource guide. | 19 |
| Total | 36 |
Baseline characteristics
| Characteristic | Navigation Intervention | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 19 Participants | 36 Participants |
| Age, Continuous | 51.7 years STANDARD_DEVIATION 9.5 | 52.6 years STANDARD_DEVIATION 7.5 | 52.14 years STANDARD_DEVIATION 8.4 |
| Race/Ethnicity, Customized Race/Ethnicity Asian/Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 14 Participants | 18 Participants | 32 Participants |
| Region of Enrollment United States | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 19 |
| other Total, other adverse events | 0 / 17 | 0 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 19 |
Outcome results
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)-
Time frame: 5 month follow-up
Population: The EUC did not participate in the health insurance navigation so data for this measure was not collected from the EUC arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Navigation Intervention | Acceptability of the Health Insurance Navigation Program | 8.8 units on a scale | Standard Deviation 1.9 |
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- * premium * deductible * co-payments * co-insurance
Time frame: baseline and 5 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Navigation Intervention | Change From Baseline Health Insurance Literacy to 5-month Follow-up | 5.6 score on a scale | Standard Deviation 7.5 |
| Enhanced Usual Care | Change From Baseline Health Insurance Literacy to 5-month Follow-up | 1.1 score on a scale | Standard Deviation 9.2 |
Primary
Program Feasibility
Program feasibility is measured by the percentage of navigator participants completing all 5 intervention sessions.
Time frame: 5-month follow-up
Population: The EUC did not complete sessions so data for this measure was not collected from the EUC arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Navigation Intervention | Program Feasibility | 15 Participants |