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:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lgmorse@partners.org', 'phone': '617-724-2000', 'title': 'Lisa Morse', 'organization': 'Mass General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 months', 'eventGroups': [{'id': 'EG000', 'title': 'Navigation Intervention', '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 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.\n\nHealth 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.", 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability of the Health Insurance Navigation Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Intervention', '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 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.\n\nHealth 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."}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 month follow-up', 'description': '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)-\n\n* program materials\n* scheduling\n* communication with navigator\n* length and number of sessions (investigator created scale)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The EUC did not complete acceptability measures as it was intended only for the intervention group.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Completing All 4 Intervention Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Intervention', '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 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.\n\nHealth 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."}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-2 months follow-up', 'description': 'Program feasibility is measured by the percentage of participants completing all 4 intervention sessions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The EUC did not complete any intervention sessions. The percent below reflects % of intervention participants completing all 4 intervention sessions.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Familiarity With ACA Provisions to 5-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Intervention', '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 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.\n\nHealth 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."}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 5 month follow-up', 'description': '6 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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Health Insurance Literacy to 5-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigation Intervention', '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 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.\n\nHealth 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."}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 5 month follow-up', 'description': '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-\n\n* premium\n* deductible\n* co-payments\n* co-insurance', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Navigation Intervention', '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 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.\n\nHealth 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."}, {'id': 'FG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Navigation Intervention', '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 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.\n\nHealth 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."}, {'id': 'BG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian/Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Non Hispanic White', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who consented and completed the baseline survey.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-20', 'size': 430567, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-25T06:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention; enhanced usual care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2020-08-12', 'resultsFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-29', 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the Health Insurance Navigation Program', 'timeFrame': '5 month follow-up', 'description': '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)-\n\n* program materials\n* scheduling\n* communication with navigator\n* length and number of sessions (investigator created scale)'}, {'measure': 'Percentage of Participants Completing All 4 Intervention Sessions', 'timeFrame': '1-2 months follow-up', 'description': 'Program feasibility is measured by the percentage of participants completing all 4 intervention sessions.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Familiarity With ACA Provisions to 5-month Follow-up', 'timeFrame': 'baseline and 5 month follow-up', 'description': '6 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)'}, {'measure': 'Change From Baseline Health Insurance Literacy to 5-month Follow-up', 'timeFrame': 'baseline and 5 month follow-up', 'description': '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-\n\n* premium\n* deductible\n* co-payments\n* co-insurance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['survivorship'], 'conditions': ['Health Insurance', 'Childhood Cancer Survivors']}, 'referencesModule': {'references': [{'pmid': '16361621', 'type': 'BACKGROUND', 'citation': 'Park ER, Li FP, Liu Y, Emmons KM, Ablin A, Robison LL, Mertens AC; Childhood Cancer Survivor Study. Health insurance coverage in survivors of childhood cancer: the Childhood Cancer Survivor Study. J Clin Oncol. 2005 Dec 20;23(36):9187-97. doi: 10.1200/JCO.2005.01.7418.'}, {'pmid': '24304873', 'type': 'BACKGROUND', 'citation': 'Robison LL, Hudson MM. Survivors of childhood and adolescent cancer: life-long risks and responsibilities. Nat Rev Cancer. 2014 Jan;14(1):61-70. doi: 10.1038/nrc3634. Epub 2013 Dec 5.'}, {'pmid': '22592507', 'type': 'BACKGROUND', 'citation': "Park ER, Kirchhoff AC, Zallen JP, Weissman JS, Pajolek H, Mertens AC, Armstrong GT, Robison LL, Donelan K, Recklitis CJ, Diller LR, Kuhlthau KA. Childhood Cancer Survivor Study participants' perceptions and knowledge of health insurance coverage: implications for the Affordable Care Act. J Cancer Surviv. 2012 Sep;6(3):251-9. doi: 10.1007/s11764-012-0225-y. Epub 2012 May 17."}, {'pmid': '15053285', 'type': 'BACKGROUND', 'citation': 'Oeffinger KC, Mertens AC, Hudson MM, Gurney JG, Casillas J, Chen H, Whitton J, Yeazel M, Yasui Y, Robison LL. Health care of young adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Ann Fam Med. 2004 Jan-Feb;2(1):61-70. doi: 10.1370/afm.26.'}, {'pmid': '14745882', 'type': 'BACKGROUND', 'citation': 'Yeazel MW, Oeffinger KC, Gurney JG, Mertens AC, Hudson MM, Emmons KM, Chen H, Robison LL. The cancer screening practices of adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2004 Feb 1;100(3):631-40. doi: 10.1002/cncr.20008.'}, {'pmid': '21509774', 'type': 'BACKGROUND', 'citation': 'Casillas J, Castellino SM, Hudson MM, Mertens AC, Lima IS, Liu Q, Zeltzer LK, Yasui Y, Robison LL, Oeffinger KC. Impact of insurance type on survivor-focused and general preventive health care utilization in adult survivors of childhood cancer: the Childhood Cancer Survivor Study (CCSS). Cancer. 2011 May 1;117(9):1966-75. doi: 10.1002/cncr.25688. Epub 2010 Nov 10.'}, {'pmid': '24408440', 'type': 'BACKGROUND', 'citation': 'Keegan TH, Tao L, DeRouen MC, Wu XC, Prasad P, Lynch CF, Shnorhavorian M, Zebrack BJ, Chu R, Harlan LC, Smith AW, Parsons HM; AYA HOPE Study Collaborative Group. Medical care in adolescents and young adult cancer survivors: what are the biggest access-related barriers? J Cancer Surviv. 2014 Jun;8(2):282-92. doi: 10.1007/s11764-013-0332-4. Epub 2014 Jan 10.'}, {'pmid': '23007632', 'type': 'BACKGROUND', 'citation': 'Kirchhoff AC, Lyles CR, Fluchel M, Wright J, Leisenring W. Limitations in health care access and utilization among long-term survivors of adolescent and young adult cancer. Cancer. 2012 Dec 1;118(23):5964-72. doi: 10.1002/cncr.27537. Epub 2012 Sep 24.'}, {'pmid': '19996459', 'type': 'BACKGROUND', 'citation': 'Mulrooney DA, Yeazel MW, Kawashima T, Mertens AC, Mitby P, Stovall M, Donaldson SS, Green DM, Sklar CA, Robison LL, Leisenring WM. Cardiac outcomes in a cohort of adult survivors of childhood and adolescent cancer: retrospective analysis of the Childhood Cancer Survivor Study cohort. BMJ. 2009 Dec 8;339:b4606. doi: 10.1136/bmj.b4606.'}, {'pmid': '21035130', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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).\n\nAs 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.\n\nAs 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.\n\nApproximately 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age\n* access to a smartphone, computer, or tablet with internet access\n* currently has health insurance\n\nExclusion Criteria:\n\n* under 18 years of age\n* unable to give consent due to psychiatric or cognitive impairment\n* lack of access to a smartphone, computer, or tablet with internet access\n* does not currently have health insurance'}, 'identificationModule': {'nctId': 'NCT04520061', 'acronym': 'HINT', 'briefTitle': 'Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer', 'orgStudyIdInfo': {'id': '2018P003088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigation Intervention', '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 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.', 'interventionNames': ['Behavioral: Health Insurance Navigation Program']}, {'type': 'NO_INTERVENTION', 'label': 'Enhanced Usual Care', 'description': 'Enhanced usual care will consist of an online or mailed health insurance resource guide.'}], 'interventions': [{'name': 'Health Insurance Navigation Program', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Navigation Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Elyse R Park, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not make individual participant data available to any researchers outside of those approved to work on the study under the central IRB.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elyse Park, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}