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
Fairbanks, Alaska 99701
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Little Rock, Arkansas 72205
Martinez, California 94553-3156
Site Public Contact
925-957-5400
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 80220
Englewood, Colorado 80113
Englewood, Colorado 80113
Lakewood, Colorado 80228
Littleton, Colorado 80120
Lone Tree, Colorado 80124
Longmont, Colorado 80501
Thornton, Colorado 80260
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Site Public Contact
808-532-0315
Honolulu, Hawaii 96813
Site Public Contact
808-545-8548
Honolulu, Hawaii 96813
Site Public Contact
808-522-4333
Honolulu, Hawaii 96813
Site Public Contact
808-586-2979
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
Site Public Contact
808-547-9816
Honolulu, Hawaii 96817
Site Public Contact
808-531-8521
Honolulu, Hawaii 96817
Site Public Contact
808-547-6881
Honolulu, Hawaii 96826
Site Public Contact
808-983-6090
Kahului, Hawaii 96732
Kailua, Hawaii 96734
Lihue, Hawaii 96766
Site Public Contact
808-535-7960
‘Aiea, Hawaii 96701
‘Aiea, Hawaii 96701
Site Public Contact
808-486-6000
‘Aiea, Hawaii 96701
Site Public Contact
808-487-7447
‘Aiea, Hawaii 96701
Site Public Contact
808-678-9000
‘Ewa Beach, Hawaii 96706
Alton, Illinois 62002
Site Public Contact
618-463-5623
Centralia, Illinois 62801
Mount Vernon, Illinois 62864
Site Public Contact
618-242-4600
Garden City, Kansas 67846
Great Bend, Kansas 67530
Paducah, Kentucky 42003
Battle Creek, Michigan 49017
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49048
Muskegon, Michigan 49444
Niles, Michigan 49120
Site Public Contact
616-391-1230
Norton Shores, Michigan 49444
Reed City, Michigan 49677
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Traverse City, Michigan 49684
Wyoming, Michigan 49519
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Wyoming, Minnesota 55092
Oxford, Mississippi 38655
Ballwin, Missouri 63011
Site Public Contact
314-251-7058
Bolivar, Missouri 65613
Branson, Missouri 65616
Site Public Contact
417-269-4520
Joplin, Missouri 64804
Joplin, Missouri 64804
Osage Beach, Missouri 65065
Rolla, Missouri 65401
Rolla, Missouri 65401
Site Public Contact
573-458-6379
Saint Joseph, Missouri 64506
Springfield, Missouri 65804
Site Public Contact
417-269-4520
Springfield, Missouri 65807
Site Public Contact
417-269-4520
St Louis, Missouri 63109
Site Public Contact
314-353-1870
St Louis, Missouri 63128
St Louis, Missouri 63141
Site Public Contact
314-251-7066
Washington, Missouri 63090
Site Public Contact
636-390-1600
Asheboro, North Carolina 27203
Site Public Contact
336-832-0836
Asheboro, North Carolina 27203
Burlington, North Carolina 27215
Greensboro, North Carolina 27403
Greensboro, North Carolina 27410
Reidsville, North Carolina 27320
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
Site Public Contact
405-752-3402
Danville, Pennsylvania 17822
Hazleton, Pennsylvania 18201
Lewisburg, Pennsylvania 17837
Pottsville, Pennsylvania 17901
Scranton, Pennsylvania 18510
Selinsgrove, Pennsylvania 17870
Wilkes-Barre, Pennsylvania 18711
Memphis, Tennessee 38120
Mechanicsville, Virginia 23116
Midlothian, Virginia 23113
Midlothian, Virginia 23114
Richmond, Virginia 23223
Richmond, Virginia 23226
Richmond, Virginia 23230
Port Townsend, Washington 98368
Site Public Contact
360-344-3091
Appleton, Wisconsin 54911
Appleton, Wisconsin 54915
Berlin, Wisconsin 54923
Brookfield, Wisconsin 53045
Chilton, Wisconsin 53014
Franklin, Wisconsin 53132
Franklin, Wisconsin 53132
La Crosse, Wisconsin 54601
Mequon, Wisconsin 53097
Milwaukee, Wisconsin 53210
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53215
Neenah, Wisconsin 54956
New London, Wisconsin 54961
New Richmond, Wisconsin 54017
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53405
Shawano, Wisconsin 54166
Stevens Point, Wisconsin 54482
Waupaca, Wisconsin 54981
Wausau, Wisconsin 54401
Site Public Contact
877-405-6866
Wausau, Wisconsin 54401
Wauwatosa, Wisconsin 53226
Weston, Wisconsin 54476
Bayamón, Puerto Rico 00959-5060
Site Public Contact
787-395-7085
Bayamón, Puerto Rico 00961
Site Public Contact
787-780-2865
Manatí, Puerto Rico 00674
Site Public Contact
787-621-4397
San Juan, Puerto Rico 00917
Site Public Contact
787-274-3387
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00936
Site Public Contact
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.