Trial Outcomes & Findings for Improving Health Insurance Experiences for Adolescent and Young Adult Cancer Patients (NCT NCT04448678)
NCT ID: NCT04448678
Last Updated: 2024-01-05
Results Overview
Comparing total number of individuals enrolled and randomized vs completed study (completion of both surveys for control or both surveys and all of the sessions for intervention.)
COMPLETED
NA
86 participants
Post-Assessment survey (Weeks 13 (+/- 2 weeks))
2024-01-05
Participant Flow
We decided to overshoot our original target just to have the extra data.
Participant milestones
| Measure |
HIEP Intervention
Participants will be randomized to receive the insurance navigation intervention from patient navigators, which includes four, one hour long, educational learning sessions. Randomization will be done by age at diagnosis and site.
Health Insurance Education Program (HIEP): \[See arm/group descriptions\]
|
Usual Care
Participants will be randomized to receive standard navigation provided by patient navigators ("usual care").
Usual Care: \[See arm/group descriptions\]
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
41
|
|
Overall Study
COMPLETED
|
25
|
39
|
|
Overall Study
NOT COMPLETED
|
20
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some of the participants (n=4) did not fill in all of the fields required for us to analyze their COST score.
Baseline characteristics by cohort
| Measure |
HIEP Intervention
n=45 Participants
Participants will be randomized to receive the insurance navigation intervention from patient navigators, which includes four, one hour long, educational learning sessions. Randomization will be done by age at diagnosis and site.
Health Insurance Education Program (HIEP): \[See arm/group descriptions\]
|
Usual Care
n=41 Participants
Participants will be randomized to receive standard navigation provided by patient navigators ("usual care").
Usual Care: \[See arm/group descriptions\]
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=86 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=45 Participants
|
41 Participants
n=41 Participants
|
86 Participants
n=86 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=86 Participants
|
|
Age, Continuous
|
28.96 Years
STANDARD_DEVIATION 7.19 • n=45 Participants
|
28.71 Years
STANDARD_DEVIATION 6.15 • n=41 Participants
|
28.84 Years
STANDARD_DEVIATION 6.68 • n=86 Participants
|
|
Age, Customized
Younger Group Age 18-25
|
17 Participants
n=45 Participants
|
13 Participants
n=41 Participants
|
30 Participants
n=86 Participants
|
|
Age, Customized
Older Group Age 26-39
|
28 Participants
n=45 Participants
|
28 Participants
n=41 Participants
|
56 Participants
n=86 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=45 Participants
|
31 Participants
n=41 Participants
|
59 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=45 Participants
|
10 Participants
n=41 Participants
|
27 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=45 Participants
|
10 Participants
n=41 Participants
|
16 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=45 Participants
|
30 Participants
n=41 Participants
|
69 Participants
n=86 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=86 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=45 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=86 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=45 Participants
|
26 Participants
n=41 Participants
|
62 Participants
n=86 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=45 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=86 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=45 Participants
|
11 Participants
n=41 Participants
|
17 Participants
n=86 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=45 Participants
|
41 participants
n=41 Participants
|
86 participants
n=86 Participants
|
|
COmprehensive Score for financial Toxicity (COST)
|
19.72 Score on a scale
STANDARD_DEVIATION 9.72 • n=43 Participants • Some of the participants (n=4) did not fill in all of the fields required for us to analyze their COST score.
|
20.18 Score on a scale
STANDARD_DEVIATION 12.20 • n=39 Participants • Some of the participants (n=4) did not fill in all of the fields required for us to analyze their COST score.
|
19.94 Score on a scale
STANDARD_DEVIATION 10.90 • n=82 Participants • Some of the participants (n=4) did not fill in all of the fields required for us to analyze their COST score.
|
|
Health Insurance Literacy Measure (HILM)
|
22.64 Score on a scale
STANDARD_DEVIATION 5.21 • n=44 Participants • Some of the participants (n=1) did not fill in all of the fields required for us to analyze their HILM score.
|
22.46 Score on a scale
STANDARD_DEVIATION 5.81 • n=41 Participants • Some of the participants (n=1) did not fill in all of the fields required for us to analyze their HILM score.
|
22.55 Score on a scale
STANDARD_DEVIATION 5.48 • n=85 Participants • Some of the participants (n=1) did not fill in all of the fields required for us to analyze their HILM score.
|
PRIMARY outcome
Timeframe: Post-Assessment survey (Weeks 13 (+/- 2 weeks))Population: Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network.
Comparing total number of individuals enrolled and randomized vs completed study (completion of both surveys for control or both surveys and all of the sessions for intervention.)
Outcome measures
| Measure |
Usual Care
n=41 Participants
Number of participants who were randomized into care as usual versus those who completed the study (follow up survey).
|
HIEP Intervention
n=45 Participants
Number of participants who were randomized into the Health Insurance Educational Program versus those who completed the study (all 4 sessions and the follow up survey).
|
Combined
All participants
|
|---|---|---|---|
|
Feasibility Measurement
|
39 Participants
|
25 Participants
|
—
|
PRIMARY outcome
Timeframe: Post-Assessment interview (Weeks 18 (+/- 2 weeks))Population: Analysis of participants satisfaction from questions asked in the exit interview. Only including participants who were randomized into the intervention, then the exit interviews, and completed at least one session of the HIEP.
Questions surrounding satisfaction with the HIEP. These will be asked at the post-assessment interview and will consist of participants responses surrounding satisfaction with the HIEP. We will report percentages of participants who did 1 or more session and reported satisfaction with the HIEP.
Outcome measures
| Measure |
Usual Care
n=10 Participants
Number of participants who were randomized into care as usual versus those who completed the study (follow up survey).
|
HIEP Intervention
Number of participants who were randomized into the Health Insurance Educational Program versus those who completed the study (all 4 sessions and the follow up survey).
|
Combined
All participants
|
|---|---|---|---|
|
Acceptability - Module Satisfaction
|
10 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Post-Assessment survey (Weeks 13 (+/- 2 weeks))Population: Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network.
Validated Patient Satisfaction with Navigator Interpersonal Relationship (PSN-I) measure at post assessment survey. This score ranges from 0-45 with higher scores indicating higher satisfaction. We will report the mean and standard deviation.
Outcome measures
| Measure |
Usual Care
n=45 Participants
Number of participants who were randomized into care as usual versus those who completed the study (follow up survey).
|
HIEP Intervention
n=41 Participants
Number of participants who were randomized into the Health Insurance Educational Program versus those who completed the study (all 4 sessions and the follow up survey).
|
Combined
All participants
|
|---|---|---|---|
|
Navigator Satisfaction
|
30.84 score on a scale
Standard Deviation 16.15
|
30.32 score on a scale
Standard Deviation 12.95
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))Population: Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network.
Differences between Health Insurance Literacy Measure (HILM) reported at the intro baseline and exit post-assessment survey. For this study, the last two sections (3\&4) of the HILM were used. Scores range from 9-36 with lower scores indicate lower health insurance literacy and worse outcomes. Differences will be examined by age group and by treatment arm. We report mean and standard deviation. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
Outcome measures
| Measure |
Usual Care
n=36 Participants
Number of participants who were randomized into care as usual versus those who completed the study (follow up survey).
|
HIEP Intervention
n=36 Participants
Number of participants who were randomized into the Health Insurance Educational Program versus those who completed the study (all 4 sessions and the follow up survey).
|
Combined
n=72 Participants
All participants
|
|---|---|---|---|
|
Changes in Efficacy- Health Insurance Literacy
|
5.39 Score on a scale
Standard Deviation 6.44
|
2.30 Score on a scale
Standard Deviation 6.06
|
3.84 Score on a scale
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Post Assessment survey (Weeks 13 (+/- 2 weeks))Population: Insured cancer patients between the ages of 18-39 who are within their first year of treatment at Huntsman Cancer Institute or the Intermountain Network.
Questions surrounding familiarity with the ACA reported at the baseline and post-assessment survey. Values range from 0 to 28 with higher scores indicating better familiarity with ACA concepts. We will report the mean and standard deviation of the difference in response scores between baseline and post assessment for the control and intervention. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
Outcome measures
| Measure |
Usual Care
n=37 Participants
Number of participants who were randomized into care as usual versus those who completed the study (follow up survey).
|
HIEP Intervention
n=37 Participants
Number of participants who were randomized into the Health Insurance Educational Program versus those who completed the study (all 4 sessions and the follow up survey).
|
Combined
n=74 Participants
All participants
|
|---|---|---|---|
|
Changes in Efficacy- Affordable Care Act (ACA) Familiarity
|
5.84 Score on a scale
Standard Deviation 6.30
|
2.03 Score on a scale
Standard Deviation 4.89
|
3.93 Score on a scale
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Post Assessment survey ( Weeks 13 (+/- 2 weeks))Differences between COmprehensive Score for financial Toxicity (COST) reported at the baseline and post-assessment survey. Values range from 0 to 44 where lower COST scores indicate worse financial toxicity. Differences will be examined by age group and by treatment arm. We will report mean and standard deviation. Please note that not all participants, filled out all necessary questions at both timepoints to be assessed.
Outcome measures
| Measure |
Usual Care
n=35 Participants
Number of participants who were randomized into care as usual versus those who completed the study (follow up survey).
|
HIEP Intervention
n=36 Participants
Number of participants who were randomized into the Health Insurance Educational Program versus those who completed the study (all 4 sessions and the follow up survey).
|
Combined
n=71 Participants
All participants
|
|---|---|---|---|
|
Changes in Efficacy-Financial Distress
Younger group (18-25)
|
3.70 Score on a scale
Standard Deviation 9.59
|
2.89 Score on a scale
Standard Deviation 9.44
|
3.32 Score on a scale
Standard Deviation 9.26
|
|
Changes in Efficacy-Financial Distress
Older group (26-39)
|
3.08 Score on a scale
Standard Deviation 8.45
|
0.741 Score on a scale
Standard Deviation 6.42
|
1.87 Score on a scale
Standard Deviation 7.48
|
|
Changes in Efficacy-Financial Distress
Combined (18-39)
|
3.25 Score on a scale
Standard Deviation 8.65
|
1.28 Score on a scale
Standard Deviation 7.20
|
2.25 Score on a scale
Standard Deviation 7.95
|
Adverse Events
HIEP Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place