RECRUITING

Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

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Conditions

Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

Quick Facts

Study Start:2024-02-29
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06295367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * NON-PATIENTS PARTICIPANTS: Participant must speak English
  2. * NON-PATIENTS PARTICIPANTS: Participant must be employed at National Cancer Institute Community Oncology Research Program (NCORP) site for at least six months
  3. * NON-PATIENTS PARTICIPANTS: Participant must be able to provide informed consent to participate in this study
  4. * NON-PATIENTS PARTICIPANTS: Participant must be one of the following:
  5. * A study coordinator with a role involving use of CostCOM intervention price transparency and financial navigation platform
  6. * A practice oncology provider (i.e., physician or mid-level), or
  7. * A practice financial counselor, social workers, financial navigators, or pharmacist who have provided care or been in contact (in the last 3 months) to a patient who was assigned to the CostCOM arm, and who completed the at least 6 month study follow-up
  8. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be ≥ 18 years of age
  9. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
  10. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be within 120 days of a new diagnosis of any solid cancer of any stage at the time of Step 0
  11. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have had their first medical oncology visit at the time of Step 0
  12. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have initiated oral or intravenous (IV) cancer systemic therapy or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent
  13. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not have indolent cancer undergoing observation alone (i.e., active surveillance)
  14. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not be receiving palliative or hospice care alone
  15. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be undergoing curative surgery alone or radiation therapy alone. (Must be receiving systemic therapy), unless they are receiving systemic therapy
  16. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must confirm that they intend to receive their care or monitoring at one of the participating NCORP practices
  17. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have the ability to understand and the willingness to sign a written informed consent document.
  18. * Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible
  19. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3, OR
  20. * Patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)
  21. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in treatment clinical trials where cancer systemic therapy is provided at no cost to the patient
  22. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in EAQ221CD or S1912CD given financial navigation is offered as part of these two trials.
  23. * NOTE: If S1912CD is activated in a participating practice, S1912CD should be offered first to patients with metastatic cancer meeting eligibility criteria for S1912CD. Only if a patient is not eligible or not interested in participating in S1912CD, the EAQ222CD can be offered. For early stage cancer, EAQ222CD can be offered first given S1912CD does not enroll patients with early stage cancer
  24. * PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in other clinical trials where OOPC communication or financial navigation (i.e., professional guidance to identify financial assistance programs to alleviate cost of care) is being offered as part of the trial
  25. * NOTE: If a trial is offering financial counseling alone without financial navigation patients are allowed to co-enroll
  26. * NOTE: Gift cards for survey completion, or parking passes are not considered financial navigation
  27. * PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all the eligibility criteria for step 0
  28. * PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have signed a written informed consent form
  29. * PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have a completed baseline survey in ECOG American College of Radiology Imaging Network Systems for Easy Entry of Patient Reported Outcomes (EASEE-PRO) within 30 days of the date of OPEN registration and consent (step 0)
  30. * PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy) either before or within 30 days of the date of OPEN registration and consent (step 0)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Gelareh Sadigh
PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
CARTI Cancer Center
Little Rock, Arkansas, 72205
United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
United States
BASS Medical Group - Lennon
Walnut Creek, California, 94598
United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
United States
The Women's Imaging Center
Denver, Colorado, 80209
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501
United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
United States
Hawaii Cancer Care - Westridge
'Aiea, Hawaii, 96701
United States
Pali Momi Medical Center
'Aiea, Hawaii, 96701
United States
Queen's Cancer Center - Pearlridge
'Aiea, Hawaii, 96701
United States
The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii, 96701
United States
The Queen's Medical Center - West Oahu
'Ewa Beach, Hawaii, 96706
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Hawaii Diagnostic Radiology Services LLC
Honolulu, Hawaii, 96817
United States
Kuakini Medical Center
Honolulu, Hawaii, 96817
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Straub Medical Center - Kahului Clinic
Kahului, Hawaii, 96732
United States
Castle Medical Center
Kailua, Hawaii, 96734
United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
United States
Saint Anthony's Health
Alton, Illinois, 62002
United States
Saint Mary's Hospital
Centralia, Illinois, 62801
United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
United States
Mercy Health - Paducah Medical Oncology and Hematology
Paducah, Kentucky, 42003
United States
Bronson Battle Creek
Battle Creek, Michigan, 49017
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
United States
Borgess Medical Center
Kalamazoo, Michigan, 49048
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
University of Michigan Health - West
Wyoming, Michigan, 49519
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Cambridge Medical Center
Cambridge, Minnesota, 55008
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Health Partners Inc
Minneapolis, Minnesota, 55454
United States
Monticello Cancer Center
Monticello, Minnesota, 55362
United States
New Ulm Medical Center
New Ulm, Minnesota, 56073
United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371
United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
United States
Lakeview Hospital
Stillwater, Minnesota, 55082
United States
Ridgeview Medical Center
Waconia, Minnesota, 55387
United States
Rice Memorial Hospital
Willmar, Minnesota, 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
United States
Cox Cancer Center Branson
Branson, Missouri, 65616
United States
Freeman Health System
Joplin, Missouri, 64804
United States
Mercy Hospital Joplin
Joplin, Missouri, 64804
United States
Lake Regional Hospital
Osage Beach, Missouri, 65065
United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
United States
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, 63109
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Mercy Hospital Washington
Washington, Missouri, 63090
United States
Cone Health Cancer Center at Asheboro
Asheboro, North Carolina, 27203
United States
Randolph Health Cancer Center
Asheboro, North Carolina, 27203
United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403
United States
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, 27410
United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320
United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601
United States
Mount Carmel East Hospital
Columbus, Ohio, 43213
United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219
United States
Mount Carmel Health Center West
Columbus, Ohio, 43222
United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
United States
Zangmeister Center Grove City
Grove City, Ohio, 43123
United States
Fairfield Medical Center
Lancaster, Ohio, 43130
United States
Saint Rita's Medical Center
Lima, Ohio, 45801
United States
Marietta Memorial Hospital
Marietta, Ohio, 45750
United States
Memorial Hospital
Marysville, Ohio, 43040
United States
Knox Community Hospital
Mount Vernon, Ohio, 43050
United States
Mount Carmel New Albany Surgical Hospital
New Albany, Ohio, 43054
United States
Licking Memorial Hospital
Newark, Ohio, 43055
United States
Newark Radiation Oncology
Newark, Ohio, 43055
United States
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, 43551
United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504
United States
Springfield Regional Medical Center
Springfield, Ohio, 45504
United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608
United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623
United States
Mercy Health Sylvania Radiation Oncology Center
Toledo, Ohio, 43623
United States
Saint Ann's Hospital
Westerville, Ohio, 43081
United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington, Ohio, 45177
United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
United States
Community Medical Center
Scranton, Pennsylvania, 18510
United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
United States
Bon Secours Westchester Emergency Center
Midlothian, Virginia, 23113
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
United States
Bon Secours Richmond Community Hospital
Richmond, Virginia, 23223
United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
United States
Jefferson Healthcare
Port Townsend, Washington, 98368
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
United States
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923
United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
United States
Ascension Calumet Hospital
Chilton, Wisconsin, 53014
United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
United States
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, 53132
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097
United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, 53210
United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211
United States
Ascension Saint Francis Hospital
Milwaukee, Wisconsin, 53215
United States
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956
United States
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904
United States
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904
United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405
United States
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: ECOG-ACRIN Cancer Research Group

  • Gelareh Sadigh, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-29
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-02-29
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Solid Neoplasm