Trial Outcomes & Findings for Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer (NCT NCT04520061)
NCT ID: NCT04520061
Last Updated: 2025-02-03
Results Overview
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)- * program materials * scheduling * communication with navigator * length and number of sessions (investigator created scale)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
5 month follow-up
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
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 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.
Health Insurance Navigation Program: The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
|
Enhanced Usual Care
Enhanced usual care will consist of an online or mailed health insurance resource guide.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
37
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer
Baseline characteristics by cohort
| Measure |
Navigation Intervention
n=41 Participants
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 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.
Health Insurance Navigation Program: The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
|
Enhanced Usual Care
n=41 Participants
Enhanced usual care will consist of an online or mailed health insurance resource guide.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic White
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 month follow-upPopulation: The EUC did not complete acceptability measures as it was intended only for the intervention group.
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)- * program materials * scheduling * communication with navigator * length and number of sessions (investigator created scale)
Outcome measures
| Measure |
Navigation Intervention
n=37 Participants
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 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.
Health Insurance Navigation Program: The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
|
Enhanced Usual Care
Enhanced usual care will consist of an online or mailed health insurance resource guide.
|
|---|---|---|
|
Acceptability of the Health Insurance Navigation Program
|
8.9 units on a scale
Standard Deviation 1.2
|
—
|
PRIMARY outcome
Timeframe: 1-2 months follow-upPopulation: The EUC did not complete any intervention sessions. The percent below reflects % of intervention participants completing all 4 intervention sessions.
Program feasibility is measured by the percentage of participants completing all 4 intervention sessions.
Outcome measures
| Measure |
Navigation Intervention
n=41 Participants
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 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.
Health Insurance Navigation Program: The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
|
Enhanced Usual Care
Enhanced usual care will consist of an online or mailed health insurance resource guide.
|
|---|---|---|
|
Percentage of Participants Completing All 4 Intervention Sessions
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline and 5 month follow-up6 items rating familiarity with key Affordable Care Act (ACA) protections (scores range from 0-6; higher scores indicate higher degree of familiarity) (scale adapted from CCSS Health Insurance Survey)
Outcome measures
| Measure |
Navigation Intervention
n=37 Participants
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 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.
Health Insurance Navigation Program: The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
|
Enhanced Usual Care
n=40 Participants
Enhanced usual care will consist of an online or mailed health insurance resource guide.
|
|---|---|---|
|
Change From Baseline Familiarity With ACA Provisions to 5-month Follow-up
|
1.7 units on a scale
Standard Deviation 1.7
|
0.5 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: baseline and 5 month follow-up16 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
Outcome measures
| Measure |
Navigation Intervention
n=37 Participants
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 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.
Health Insurance Navigation Program: The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
|
Enhanced Usual Care
n=40 Participants
Enhanced usual care will consist of an online or mailed health insurance resource guide.
|
|---|---|---|
|
Change From Baseline Health Insurance Literacy to 5-month Follow-up
|
9.1 units on a scale
Standard Deviation 7.6
|
1.8 units on a scale
Standard Deviation 7.9
|
Adverse Events
Navigation Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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