Any Cancer

EAQ222CD / CostCOM



Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

STATUS: Active


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.
  • 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 at least 6 month study follow-up

  • PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be โ‰ฅ 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 โ‰ฅ 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 screening registration (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 screening registration (step 0)

United States
AK
Fairbanks
Fairbanks Memorial Hospital
Contact: Site Public Contact
Email: Veronica.Stevenson@foundationhealth.org

AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact

Little Rock
CARTI Cancer Center
Contact: Site Public Contact
Email: Research@CARTI.com

CO
Aurora
Rocky Mountain Cancer Centers-Aurora
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Boulder
Boulder Community Foothills Hospital
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Boulder
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Centennial
Rocky Mountain Cancer Centers - Centennial
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Denver
Colorado Blood Cancer Institute
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Presbyterian - Saint Lukes Medical Center - Health One
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Midtown
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Rose
Contact: Site Public Contact
Email: info@westernstatesncorp.org

The Women's Imaging Center
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Englewood
Mountain Blue Cancer Care Center - Swedish
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers - Swedish
Contact: Site Public Contact
Email: info@westernstatesncorp.org

The Melanoma and Skin Cancer Institute
Contact: Site Public Contact
Email: ryan.weight@theskincancerinstitute.com

Lakewood
Rocky Mountain Cancer Centers-Lakewood
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Littleton
Rocky Mountain Cancer Centers-Littleton
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Thornton
Rocky Mountain Cancer Centers-Thornton
Contact: Site Public Contact
Email: info@westernstatesncorp.org

IL
Alton
Saint Anthony's Health
Contact: Site Public Contact

Centralia
Saint Mary's Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

KY
Paducah
Mercy Health - Paducah Medical Oncology and Hematology
Contact: Site Public Contact
Email: BJWarner@mercy.com

MI
Battle Creek
Bronson Battle Creek
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Kalamazoo
Ascension Borgess Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Borgess Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Corewell Health Lakeland Hospitals - Niles Hospital
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Reed City
Corewell Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact

Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
Contact: Site Public Contact

Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net

Osage Beach
Lake Regional Hospital
Contact: Site Public Contact
Email: clinicaltrials@lakeregional.com

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net

Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact

Springfield
CoxHealth South Hospital
Contact: Site Public Contact

Mercy Hospital Springfield
Contact: Site Public Contact

Washington
Mercy Hospital Washington
Contact: Site Public Contact

OH
Belpre
Strecker Cancer Center-Belpre
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Chillicothe
Adena Regional Medical Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Columbus
Mount Carmel East Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Mount Carmel Health Center West
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

The Mark H Zangmeister Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Gahanna
Central Ohio Breast and Endocrine Surgery
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Grove City
Mount Carmel Grove City Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Zangmeister Center Grove City
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Lancaster
Fairfield Medical Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Lima
Saint Rita's Medical Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Marietta
Marietta Memorial Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Marysville
Memorial Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Mount Vernon
Knox Community Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

New Albany
Mount Carmel New Albany Surgical Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Newark
Licking Memorial Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Newark Radiation Oncology
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Perrysburg
Mercy Health Perrysburg Cancer Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Portsmouth
Southern Ohio Medical Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Springfield Regional Medical Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Toledo
Mercy Health Sylvania Radiation Oncology Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Mercy Health - Saint Vincent Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Westerville
Saint Ann's Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Wilmington
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

Zanesville
Genesis Healthcare System Cancer Care Center
Contact: Site Public Contact
Email: Jeffh@columbusccop.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

PR
Bayamon
Cancer Center-Metro Medical Center Bayamon
Contact: Site Public Contact

Manati
Doctors Cancer Center
Contact: Site Public Contact

San Juan
Centro Comprensivo de Cancer de UPR
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

PROncology
Contact: Site Public Contact
Email: info@PRoncology.com

San Juan City Hospital
Contact: Site Public Contact

San Juan Community Oncology Group
Contact: Site Public Contact

WI
Appleton
Ascension Saint Elizabeth Hospital
Contact: Site Public Contact
Email: AWRI.inquiry@ascension.org

ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Berlin
ThedaCare Cancer Care - Berlin
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Chilton
Ascension Calumet Hospital
Contact: Site Public Contact
Email: AWRI.inquiry@ascension.org

Franklin
Ascension Saint Francis - Reiman Cancer Center
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Ascension Southeast Wisconsin Hospital - Franklin
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Mequon
Ascension Columbia Saint Mary's Hospital Ozaukee
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Milwaukee
Ascension Columbia Saint Mary's Hospital - Milwaukee
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Ascension Saint Francis Hospital
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Neenah
ThedaCare Regional Medical Center - Neenah
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

New London
ThedaCare Cancer Care - New London
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Oshkosh
Ascension Mercy Hospital
Contact: Site Public Contact
Email: AWRI.inquiry@ascension.org

ThedaCare Cancer Care - Oshkosh
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Racine
Ascension All Saints Hospital
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Shawano
ThedaCare Cancer Care - Shawano
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Waupaca
ThedaCare Cancer Care - Waupaca
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

Wausau
Aspirus Regional Cancer Center
Contact: Site Public Contact

Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wauwatosa
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Contact: Site Public Contact
Email: AWRI.Inquiry@Ascension.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

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 patientsโ€™ satisfaction with CostCOM in patients with Arm B.
V. To assess patientsโ€™ 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 participate in a 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after the first patient randomization.

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 in Arm A are followed up at 3, 6, and 12 months after study intervention completion. Patients in Arm A may be followed up within 18 months of study intervention completion, and patients in Arm B may be followed up within 6 months of study intervention completion.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Community Oncology Research Program.

EAQ222CD / COSTCOM Home Page
ECOG-ACRIN Cancer Research Group