Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-30 @ 11:24 PM
Study NCT ID:
NCT04520061
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HINT
Brief Summary:
Dr. Park and her colleagues published findings in the Journal of Clinical Oncology demonstrating that CCSS survivors, compared to siblings, were significantly more likely to be uninsured and to have difficulties obtaining health insurance. Given the current insurance landscape and the additional insurance burden that childhood cancer survivors face, the present study seeks to develop and pilot a health insurance navigation program targeted at feasibility and acceptability with survivors, and improving health insurance literacy and ameliorating financial distress related to medical costs. The proposed health insurance navigation will involve 4 navigator-led health insurance navigation sessions. 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 intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
Detailed Description:
The present study seeks to develop and pilot a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort. Childhood cancer survivors tend to face health challenges throughout their lives that require monitoring and ongoing care. This is compounded by the tendency among childhood survivors to have higher rates of under and uninsurance, unmet healthcare need, and burdensome costs related to care.These burdensome costs also contribute to underutilization of care among survivors. Additionally, as health insurance systems and designs continue to evolve, many people have inadequate understandings of their own health insurance. Dr. Park and her colleagues published findings that suggested LTFU survivors had difficulty in understanding how to use their insurance, and often experienced financial-related distress. Survivors were more likely than their siblings to have borrowed money to pay for medical expenses, and only 27.3% of survivors and 26.2% of their siblings reported familiarity with the ACA. Given these circumstances, understanding and navigating insurance benefits in the current in the current landscape is crucial for 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 with LTFU participants.
The three institutions involved in this study have differing, complementary roles that will contribute to the development and piloting of a health insurance navigation intervention. As the lead site and IRB of record for this study, Massachusetts General Hospital (MGH) will be responsible for the development and regulation of all study-related materials. MGH will also be responsible for the delivery of the navigation intervention (which necessitates the training and supervision of the individual delivery the navigation).
As a collaborating site for this study, St. Jude Children's Research Hospital will be responsible for all recruitment activities, as this study plans to recruit exclusively from the Long-Term Follow-Up Study (LTFU) Cohort.
As a collaborating site for this study, the University of Utah will be responsible for all participant assessment during the study, which will include baseline and follow-up surveys, and exit interviews.
Approximately 80 LTFU participants will be recruited for the randomized pilot trial portion of the study. Prospective participants for the pilot randomized trial portion of the study will be identified via LTFU records, and recruited and consented by LTFU study staff at St. Jude Children's Research Hospital. Prospective participants will receive an invitation to the study through email and mail. The proposed navigation intervention will be delivered by a health insurance navigator via HIPAA-compliant videoconferencing. Content of the navigation intervention will involve the following sessions: 1- Learning Abut Survivorship Healthcare Needs; 2- Learning About Your Plan in Relation to Policy; 3- Navigating One's Own Plan and Overcoming Obstacles; 4- Managing Care Costs. The sessions will be delivered to participants every week over a one to two-month period. Participants will be randomized into either the navigation intervention arm, or the enhanced usual care arm (approximately 40 per arm). The sample size of approximately 40 per arm was chosen to enable evaluation of feasibility and acceptability goals, as well as to explore meaningful differences in the outcomes.To assess the proposed primary and secondary outcomes, all trial participants will complete a baseline and 3-month post-program follow-up survey (approximately 5-month follow-up from baseline). The surveys will be conducted via RedCap or via mailed survey (which will then be input into the RedCap database by study staff). Intervention arm participants will also complete an exit interview in order to further refine the navigation intervention. Both study arm participants will receive a health insurance information guide.
The three institutions involved in this study have differing, complementary roles that will contribute to the development and piloting of a health insurance navigation intervention. As the lead site and IRB of record for this study, Massachusetts General Hospital (MGH) will be responsible for the development and regulation of all study-related materials. MGH will also be responsible for the delivery of the navigation intervention (which necessitates the training and supervision of the individual delivery the navigation).
As a collaborating site for this study, St. Jude Children's Research Hospital will be responsible for all recruitment activities, as this study plans to recruit exclusively from the Long-Term Follow-Up Study (LTFU) Cohort.
As a collaborating site for this study, the University of Utah will be responsible for all participant assessment during the study, which will include baseline and follow-up surveys, and exit interviews.
Approximately 80 LTFU participants will be recruited for the randomized pilot trial portion of the study. Prospective participants for the pilot randomized trial portion of the study will be identified via LTFU records, and recruited and consented by LTFU study staff at St. Jude Children's Research Hospital. Prospective participants will receive an invitation to the study through email and mail. The proposed navigation intervention will be delivered by a health insurance navigator via HIPAA-compliant videoconferencing. Content of the navigation intervention will involve the following sessions: 1- Learning Abut Survivorship Healthcare Needs; 2- Learning About Your Plan in Relation to Policy; 3- Navigating One's Own Plan and Overcoming Obstacles; 4- Managing Care Costs. The sessions will be delivered to participants every week over a one to two-month period. Participants will be randomized into either the navigation intervention arm, or the enhanced usual care arm (approximately 40 per arm). The sample size of approximately 40 per arm was chosen to enable evaluation of feasibility and acceptability goals, as well as to explore meaningful differences in the outcomes.To assess the proposed primary and secondary outcomes, all trial participants will complete a baseline and 3-month post-program follow-up survey (approximately 5-month follow-up from baseline). The surveys will be conducted via RedCap or via mailed survey (which will then be input into the RedCap database by study staff). Intervention arm participants will also complete an exit interview in order to further refine the navigation intervention. Both study arm participants will receive a health insurance information guide.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: