Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)
Purpose
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.
Condition
- Malignant Solid Neoplasm
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Criteria
Inclusion Criteria:
- NON-PATIENTS PARTICIPANTS: Participant must speak English
- NON-PATIENTS PARTICIPANTS: Participant must be employed at National Cancer Institute
Community Oncology Research Program (NCORP) site for at least six months
- NON-PATIENTS PARTICIPANTS: Participant must be able to provide informed consent to
participate in this study
- NON-PATIENTS PARTICIPANTS: Participant must be one of the following:
- A study coordinator with a role involving use of CostCOM intervention price
transparency and financial navigation platform
- A practice oncology provider (i.e., physician or mid-level), or
- 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
- PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must
be ≥ 18 years of age
- 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
- 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
- PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must
have had their first medical oncology visit at the time of Step 0
- 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
- PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must
not have indolent cancer undergoing observation alone (i.e., active surveillance)
- PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must
not be receiving palliative or hospice care alone
- 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
- 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
- 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.
- Patients with impaired decision-making capacity (IDMC) who have a legally
authorized representative (LAR) or caregiver and/or family member available are
not eligible
- PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must
not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3, OR
- 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)
- 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
- 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.
- 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
- 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
- NOTE: If a trial is offering financial counseling alone without financial
navigation patients are allowed to co-enroll
- NOTE: Gift cards for survey completion, or parking passes are not considered
financial navigation
- PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all
the eligibility criteria for step 0
- PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have
signed a written informed consent form
- 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)
- 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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator ARM A (Enhanced usual care) |
Patients receive PAF brochure describing financial navigation services. |
|
|
Experimental ARM B (CostCOM) |
Patients receive usual financial care per practice standard of care and CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6 and 12 months. |
|
|
Experimental Non-patient participants: (interview) |
Non-patient participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment. |
|
Recruiting Locations
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Kingman, Arizona 86401
Fort Smith, Arkansas 72903
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800-378-9373
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
Arroyo Grande, California 93420
Burbank, California 91505
Martinez, California 94553-3156
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925-957-5400
Napa, California 94558
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707-521-3830
Santa Rosa, California 95403
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707-521-3830
Santa Rosa, California 95405
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707-521-3830
Walnut Creek, California 94598
Aurora, Colorado 80012
Boulder, Colorado 80303
Boulder, Colorado 80304
Centennial, Colorado 80112
Denver, Colorado 80209
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80220
Englewood, Colorado 80113
Englewood, Colorado 80113
Lakewood, Colorado 80228
Littleton, Colorado 80120
Lone Tree, Colorado 80124
Longmont, Colorado 80501
Thornton, Colorado 80260
Hinesville, Georgia 31313
Savannah, Georgia 31405
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
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808-532-0315
Honolulu, Hawaii 96813
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808-545-8548
Honolulu, Hawaii 96813
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808-522-4333
Honolulu, Hawaii 96813
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808-586-2979
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
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808-547-9816
Honolulu, Hawaii 96817
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808-531-8521
Honolulu, Hawaii 96817
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808-547-6881
Honolulu, Hawaii 96826
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808-983-6090
Honolulu, Hawaii 96859
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808-433-6336
Kahului, Hawaii 96732
Lihue, Hawaii 96766
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808-535-7960
‘Aiea, Hawaii 96701
‘Aiea, Hawaii 96701
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808-486-6000
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‘Ewa Beach, Hawaii 96706
Boise, Idaho 83712
Coeur d'Alene, Idaho 83814
Fruitland, Idaho 83619
Meridian, Idaho 83642
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Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Alton, Illinois 62002
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618-463-5623
Bloomington, Illinois 61704
Canton, Illinois 61520
Carbondale, Illinois 62902
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Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
Dixon, Illinois 61021
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815-285-7800
Effingham, Illinois 62401
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Normal, Illinois 61761
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O'Fallon, Illinois 62269
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Ottawa, Illinois 61350
Pekin, Illinois 61554
Peoria, Illinois 61615
Peoria, Illinois 61636
Peru, Illinois 61354
Peru, Illinois 61354
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815-664-4141
Princeton, Illinois 61356
Springfield, Illinois 62702
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Urbana, Illinois 61801
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319-365-4673
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Edina, Minnesota 55435
Edina, Minnesota 55435
Maple Grove, Minnesota 55369
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Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
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Robbinsdale, Minnesota 55422
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Shakopee, Minnesota 55379
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Woodbury, Minnesota 55125
Wyoming, Minnesota 55092
Columbus, Mississippi 39705
Grenada, Mississippi 38901
Jackson, Mississippi 39202
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601-355-2485
Jackson, Mississippi 39202
New Albany, Mississippi 38652
Oxford, Mississippi 38655
Southhaven, Mississippi 38671
Ballwin, Missouri 63011
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Bolivar, Missouri 65613
Branson, Missouri 65616
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417-269-4520
Cape Girardeau, Missouri 63703
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Farmington, Missouri 63640
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314-996-5569
Joplin, Missouri 64804
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816-404-4375
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Kansas City, Missouri 64154
Lee's Summit, Missouri 64064
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573-458-6379
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Saint Joseph, Missouri 64506
Sainte Genevieve, Missouri 63670
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Springfield, Missouri 65804
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St Louis, Missouri 63109
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St Louis, Missouri 63128
St Louis, Missouri 63131
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Sullivan, Missouri 63080
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Sunset Hills, Missouri 63127
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Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
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Helena, Montana 59601
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Las Vegas, Nevada 89103
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Las Vegas, Nevada 89109
Las Vegas, Nevada 89113
Las Vegas, Nevada 89119
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89135
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89183
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Reno, Nevada 89509
Freehold, New Jersey 07728
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Hackettstown, New Jersey 07840
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973-971-5990
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Pompton, New Jersey 07444
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973-971-5990
Summit, New Jersey 07902
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908-522-2043
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
The Bronx, New York 10461
The Bronx, New York 10467
Asheboro, North Carolina 27205
Asheville, North Carolina 28803
Burlington, North Carolina 27215
Clyde, North Carolina 28721
Greensboro, North Carolina 27403
Greensboro, North Carolina 27410
Hendersonville, North Carolina 28792
Reidsville, North Carolina 27320
Weaverville, North Carolina 28787
Belpre, Ohio 45714
Chillicothe, Ohio 45601
Columbus, Ohio 43213
Columbus, Ohio 43219
Columbus, Ohio 43222
Gahanna, Ohio 43230
Grove City, Ohio 43123
Grove City, Ohio 43123
Lancaster, Ohio 43130
Lima, Ohio 45801
Marietta, Ohio 45750
Marysville, Ohio 43040
Mount Vernon, Ohio 43050
New Albany, Ohio 43054
Newark, Ohio 43055
Newark, Ohio 43055
Perrysburg, Ohio 43551
Portsmouth, Ohio 45662
Springfield, Ohio 45504
Springfield, Ohio 45504
Toledo, Ohio 43608
Toledo, Ohio 43623
Toledo, Ohio 43623
Westerville, Ohio 43081
Wilmington, Ohio 45177
Zanesville, Ohio 43701
Oklahoma City, Oklahoma 73120
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405-752-3402
Bend, Oregon 97701
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Hood River, Oregon 97031
Newberg, Oregon 97132
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Redmond, Oregon 97756
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541-706-2909
Danville, Pennsylvania 17822
Dickson City, Pennsylvania 18519
Hazleton, Pennsylvania 18201
Lewisburg, Pennsylvania 17837
Pottsville, Pennsylvania 17901
Scranton, Pennsylvania 18510
Wilkes-Barre, Pennsylvania 18711
Bluffton, South Carolina 29910
Hilton Head Island, South Carolina 29926-3827
Hilton Head Island, South Carolina 29926
Collierville, Tennessee 38017
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Martinsville, Virginia 24112
Mechanicsville, Virginia 23116
Midlothian, Virginia 23113
Midlothian, Virginia 23114
Richmond, Virginia 23223
Richmond, Virginia 23226
Richmond, Virginia 23230
Aberdeen, Washington 98520
Bellingham, Washington 98225
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Port Townsend, Washington 98368
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360-344-3091
Renton, Washington 98055
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Spokane, Washington 99202
Spokane, Washington 99216
Spokane, Washington 99218
Vancouver, Washington 98664
Walla Walla, Washington 99362
Yakima, Washington 98902
Appleton, Wisconsin 54911
Appleton, Wisconsin 54915
Berlin, Wisconsin 54923
Brookfield, Wisconsin 53045
Chilton, Wisconsin 53014
Chippewa Falls, Wisconsin 54729
Eau Claire, Wisconsin 54701
Franklin, Wisconsin 53132
Franklin, Wisconsin 53132
Ladysmith, Wisconsin 54848
Marshfield, Wisconsin 54449
Mequon, Wisconsin 53097
Milwaukee, Wisconsin 53210
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53215
Minocqua, Wisconsin 54548
Neenah, Wisconsin 54956
Neillsville, Wisconsin 54456
New London, Wisconsin 54961
New Richmond, Wisconsin 54017
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53405
Rice Lake, Wisconsin 54868
Shawano, Wisconsin 54166
Stevens Point, Wisconsin 54482
Waupaca, Wisconsin 54981
Wausau, Wisconsin 54401
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877-405-6866
Wausau, Wisconsin 54401
Wauwatosa, Wisconsin 53226
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Bayamón, Puerto Rico 00959-5060
Site Public Contact
787-395-7085
Bayamón, Puerto Rico 00961
Site Public Contact
787-780-2865
Manati, Puerto Rico 00674
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787-621-4397
San Juan, Puerto Rico 00917
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787-274-3387
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00936
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787-763-1296
More Details
- NCT ID
- NCT06295367
- Status
- Recruiting
- Sponsor
- ECOG-ACRIN Cancer Research Group
Detailed Description
PRIMARY OBJECTIVE: I. To compare patient-reported cost-related cancer care non-adherence at 12 months after completion of baseline survey between the enhanced usual care (EUC) and CostCOM study arms. SECONDARY OBJECTIVES: I. To compare patient-reported material financial hardship at 12 months after completion of baseline survey between the EUC and CostCOM study arms. II. To compare patient-reported financial worry at 12 months after completion of baseline survey between the EUC and CostCOM study arms. III. To compare patient-reported quality of life at 12 months after completion of baseline survey between the EUC and CostCOM study arms. IV. To compare patient satisfaction with care at 12 months after completion of baseline survey between the EUC and CostCOM study arms. EXPLORATORY OBJECTIVES: I. To describe CostCOM (Arm B) patients and their provider experience with various implementation outcomes. II. To assess accuracy of out-of-pocket estimates communicated with the CostCOM (Arm B) patients at part of the intervention with their reported actual out-of-pocket cost. III. To compare neighborhood characteristics of patient participants versus (vs.) practice patient population. IV. To assess patients' satisfaction with CostCOM in patients with Arm B. V. To assess patients' receipt of financial navigation via internal practice or external resources. VI. To evaluate longitudinal changes in cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care. OUTLINE: Non-patient participants: Participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment. Patients are randomized to 1 of 2 arms. ARM A: Patients receive Patient Advocate Foundation (PAF) brochure describing financial navigation services. ARM B: Patients receive usual financial care per practice standard of care and CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6 and 12 months. Patients are followed up within 12 months of study intervention completion.