protocolSection identificationModule nctId: NCT06295367, orgStudyIdInfo id: EAQ222CD, secondaryIdInfos id: NCI-2023-09944, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAQ222CD, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: ECOG-ACRIN-EAQ222CD, type: OTHER, domain: DCP, secondaryIdInfos id: EAQ222CD, type: OTHER, domain: CTEP, secondaryIdInfos id: R01CA272680, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA272680, secondaryIdInfos id: UG1CA189828, type: NIH, link: https://reporter.nih.gov/quickSearch/UG1CA189828, briefTitle: Cost Communication and Financial Navigation in Cancer Patients (COSTCOM), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2029-08-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: ECOG-ACRIN Cancer Research Group, class: NETWORK, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer., conditionsModule conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 760, type: ESTIMATED, armsInterventionsModule interventions name: Best Practice, interventions name: Financial Navigation, interventions name: Interview, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Cost-related cancer care non-adherence, secondaryOutcomes measure: Rate of Material Financial Hardship, secondaryOutcomes measure: Patient-reported financial worry, secondaryOutcomes measure: Patient-reported Quality of life - mental and physical health, secondaryOutcomes measure: Patient-reported satisfaction with care at 12 months, otherOutcomes measure: Out of pocket cost (OOPC) accuracy, otherOutcomes measure: Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population., otherOutcomes measure: Patient reported satisfaction with intervention, otherOutcomes measure: Receipt of financial navigation via internal practice or external resources, otherOutcomes measure: Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care, otherOutcomes measure: longitudinal changes in cost-related cancer care non-adherence, otherOutcomes measure: longitudinal changes in cost-related cancer care material hardship, otherOutcomes measure: longitudinal changes in cost-related cancer care financial worry, otherOutcomes measure: longitudinal changes in cost-related cancer care quality of life, otherOutcomes measure: longitudinal changes in cost-related cancer care satisfaction with care, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mercy Hospital Fort Smith, status: RECRUITING, city: Fort Smith, state: Arkansas, zip: 72903, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 800-378-9373, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.38592, lon: -94.39855, locations facility: CARTI Cancer Center, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72205, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 501-906-4199, email: Research@CARTI.com, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Saint Anthony's Health, status: RECRUITING, city: Alton, state: Illinois, zip: 62002, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 618-463-5623, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.8906, lon: -90.18428, locations facility: Saint Mary's Hospital, status: RECRUITING, city: Centralia, state: Illinois, zip: 62801, country: United States, contacts name: Site Public Contact, role: CONTACT, email: ecog.rss@jimmy.harvard.edu, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.52505, lon: -89.1334, locations facility: Good Samaritan Regional Health Center, status: RECRUITING, city: Mount Vernon, state: Illinois, zip: 62864, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 618-242-4600, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.31727, lon: -88.90312, locations facility: Central Care Cancer Center - Garden City, status: RECRUITING, city: Garden City, state: Kansas, zip: 67846, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 913-948-5588, email: aroland@kccop.org, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.97169, lon: -100.87266, locations facility: Central Care Cancer Center - Great Bend, status: RECRUITING, city: Great Bend, state: Kansas, zip: 67530, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 913-948-5588, email: aroland@kccop.org, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.36446, lon: -98.76481, locations facility: Saint Louis Cancer and Breast Institute-Ballwin, status: RECRUITING, city: Ballwin, state: Missouri, zip: 63011, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-251-7058, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.59505, lon: -90.54623, locations facility: Central Care Cancer Center - Bolivar, status: RECRUITING, city: Bolivar, state: Missouri, zip: 65613, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 913-948-5588, email: aroland@kccop.org, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.61448, lon: -93.41047, locations facility: Cox Cancer Center Branson, status: RECRUITING, city: Branson, state: Missouri, zip: 65616, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-269-4520, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.64367, lon: -93.21851, locations facility: Freeman Health System, status: RECRUITING, city: Joplin, state: Missouri, zip: 64804, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-347-4030, email: LJCrockett@freemanhealth.com, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.08423, lon: -94.51328, locations facility: Mercy Hospital Joplin, status: RECRUITING, city: Joplin, state: Missouri, zip: 64804, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-556-3074, email: esmeralda.carrillo@mercy.net, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.08423, lon: -94.51328, locations facility: Lake Regional Hospital, status: RECRUITING, city: Osage Beach, state: Missouri, zip: 65065, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 573-302-2768, email: clinicaltrials@lakeregional.com, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.12956, lon: -92.65277, locations facility: Delbert Day Cancer Institute at PCRMC, status: RECRUITING, city: Rolla, state: Missouri, zip: 65401, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 573-458-7504, email: research@phelpshealth.org, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.95143, lon: -91.77127, locations facility: Mercy Clinic-Rolla-Cancer and Hematology, status: RECRUITING, city: Rolla, state: Missouri, zip: 65401, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 573-458-6379, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.95143, lon: -91.77127, locations facility: Heartland Regional Medical Center, status: RECRUITING, city: Saint Joseph, state: Missouri, zip: 64506, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 816-271-7937, email: linda.schumacher@mymlc.com, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76861, lon: -94.84663, locations facility: Saint Louis Cancer and Breast Institute-South City, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63109, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-353-1870, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Mercy Hospital South, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63128, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-525-6042, email: Danielle.Werle@mercy.net, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Mercy Hospital Saint Louis, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63141, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 314-251-7066, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Mercy Hospital Springfield, status: RECRUITING, city: Springfield, state: Missouri, zip: 65804, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-269-4520, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: CoxHealth South Hospital, status: RECRUITING, city: Springfield, state: Missouri, zip: 65807, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 417-269-4520, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Mercy Hospital Washington, status: RECRUITING, city: Washington, state: Missouri, zip: 63090, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 636-390-1600, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.55811, lon: -91.01209, locations facility: Strecker Cancer Center-Belpre, status: RECRUITING, city: Belpre, state: Ohio, zip: 45714, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 800-523-3977, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.27396, lon: -81.5729, locations facility: Adena Regional Medical Center, status: RECRUITING, city: Chillicothe, state: Ohio, zip: 45601, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 877-779-7585, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.33312, lon: -82.9824, locations facility: Mount Carmel East Hospital, status: RECRUITING, city: Columbus, state: Ohio, zip: 43213, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: The Mark H Zangmeister Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43219, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Mount Carmel Health Center West, status: RECRUITING, city: Columbus, state: Ohio, zip: 43222, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-234-5433, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Central Ohio Breast and Endocrine Surgery, status: RECRUITING, city: Gahanna, state: Ohio, zip: 43230, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2745, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.01923, lon: -82.87934, locations facility: Mount Carmel Grove City Hospital, status: RECRUITING, city: Grove City, state: Ohio, zip: 43123, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 877-779-7585, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.88145, lon: -83.09296, locations facility: Zangmeister Center Grove City, status: RECRUITING, city: Grove City, state: Ohio, zip: 43123, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2745, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.88145, lon: -83.09296, locations facility: Fairfield Medical Center, status: RECRUITING, city: Lancaster, state: Ohio, zip: 43130, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-687-8863, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.71368, lon: -82.59933, locations facility: Saint Rita's Medical Center, status: RECRUITING, city: Lima, state: Ohio, zip: 45801, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 419-226-9617, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.74255, lon: -84.10523, locations facility: Marietta Memorial Hospital, status: RECRUITING, city: Marietta, state: Ohio, zip: 45750, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 800-523-3977, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.41535, lon: -81.45484, locations facility: Memorial Hospital, status: RECRUITING, city: Marysville, state: Ohio, zip: 43040, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.23645, lon: -83.36714, locations facility: Knox Community Hospital, status: RECRUITING, city: Mount Vernon, state: Ohio, zip: 43050, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-393-9000, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.3934, lon: -82.48572, locations facility: Mount Carmel New Albany Surgical Hospital, status: RECRUITING, city: New Albany, state: Ohio, zip: 43054, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2745, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.08117, lon: -82.80879, locations facility: Licking Memorial Hospital, status: RECRUITING, city: Newark, state: Ohio, zip: 43055, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-348-4000, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.05812, lon: -82.40126, locations facility: Newark Radiation Oncology, status: RECRUITING, city: Newark, state: Ohio, zip: 43055, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.05812, lon: -82.40126, locations facility: Mercy Health Perrysburg Cancer Center, status: RECRUITING, city: Perrysburg, state: Ohio, zip: 43551, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.557, lon: -83.62716, locations facility: Southern Ohio Medical Center, status: RECRUITING, city: Portsmouth, state: Ohio, zip: 45662, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.73174, lon: -82.99767, locations facility: Springfield Regional Cancer Center, status: RECRUITING, city: Springfield, state: Ohio, zip: 45504, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 937-528-2900, email: clinical.trials@daytonncorp.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.92423, lon: -83.80882, locations facility: Springfield Regional Medical Center, status: RECRUITING, city: Springfield, state: Ohio, zip: 45505, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 937-528-2900, email: clinical.trials@daytonncorp.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.92423, lon: -83.80882, locations facility: Saint Vincent Mercy Medical Center, status: RECRUITING, city: Toledo, state: Ohio, zip: 43608, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66394, lon: -83.55521, locations facility: Mercy Health - Saint Anne Hospital, status: RECRUITING, city: Toledo, state: Ohio, zip: 43623, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-488-2118, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66394, lon: -83.55521, locations facility: Saint Ann's Hospital, status: RECRUITING, city: Westerville, state: Ohio, zip: 43081, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 614-234-5433, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.12617, lon: -82.92907, locations facility: Clinton Memorial Hospital, status: RECRUITING, city: Wilmington, state: Ohio, zip: 45177, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 937-283-2273, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.44534, lon: -83.82854, locations facility: Genesis Healthcare System Cancer Care Center, status: RECRUITING, city: Zanesville, state: Ohio, zip: 43701, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 740-454-5232, email: sheree@columbusccop.org, contacts name: Timothy D. Moore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.94035, lon: -82.01319, locations facility: Mercy Hospital Oklahoma City, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73120, country: United States, contacts name: Site Public Contact, role: CONTACT, phone: 405-752-3402, contacts name: Jay W. Carlson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.46756, lon: -97.51643, hasResults: False