S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer



Status:Recruiting
Conditions:Colorectal Cancer, Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:April 2016
End Date:June 2020
Contact:Patricia N O'Kane
Email:pokane@swog.org
Phone:210-614-8808

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Implementation of a Prospective Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer

This clinical trial studies the use of the financial impact assessment tool in patients with
colorectal cancer that has spread from the primary site to other places in the body.
Gathering information about patients with colorectal cancer over time may help doctors better
understand the financial impact of cancer and help patients avoid financial problems during
treatment.

PRIMARY OBJECTIVES:

I. To estimate the incidence of treatment-related major financial hardship over 12 months,
among patients with newly diagnosed metastatic colorectal cancer (mCRC) treated at components
and subcomponents of the National Cancer Institute (NCI) Community Oncology Research Program
(NCORP).

SECONDARY OBJECTIVES:

I. To describe the association of major financial hardships with mCRC treatment by
demographic factors, including age, race, marital status, employment status, and income.

II. To explore whether occurrence of major financial hardship is associated with poorer
health-related quality of life over time.

III. To profile the magnitude and timing of treatment-related changes in patients' income,
assets, debt, and employment, and to quantify major out-of-pocket expenses during the 12
months following registration.

IV. To explore the extent to which health insurance factors (e.g. high copayments,
deductibles, premiums, loss/change of insurance plan) are associated with major financial
hardship and treatment non-adherence.

V. To determine feasibility of recruiting primary caregivers and measuring caregiver burden
and caregivers' perceptions about cancer treatment costs.

VI. To determine the feasibility of conducting a prospective-multi-site longitudinal cohort
study assessing financial outcomes in patients with mCRC undergoing treatment within the
NCORP network.

TERTIARY OBJECTIVES:

I. To obtain objective measures of expenses, debt and credit through linkage with individual
patient credit reports (TransUnion) at enrollment (baseline) and end of follow up (12
months).

OUTLINE:

Patients complete questionnaires (including the Baseline, Financial/Employment Impact,
Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60
minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over
30-60 minutes at baseline and at 6 and 12 months.

Inclusion Criteria:

- Patients must have newly diagnosed metastatic colon or rectal cancer (mCRC) (de novo
metastatic diagnosis) or metastatic recurrence after prior treatment for stage I-III
disease and be
- Systemic chemotherapy and/or systemic biologic therapy must be planned to be
administered within 30 days after registration or must have been initiated within 60
days prior to registration; patients who are planning palliative or hospice care only
(no chemotherapy or biologic therapy) are not eligible

- Registering site must be an NCORP site; it is recommended that patients receive care
for the mCRC at the registering site to ensure accessibility of patient records.

- Patients must be able to complete questionnaires in English

- Patients must provide their full name, primary address in the United States (U.S.),
birth date and social security number at registration for the purposes of accessing
credit report data

- Patients must sign and give written informed consent in accordance with institutional
and federal guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system
We found this trial at
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Findlay, Ohio 45840
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
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Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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Bremerton, Washington 98310
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1 Hurley Plaza
Flint, Michigan 48503
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
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200 North Park Street
Kalamazoo, Michigan 49007
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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4805 Northeast Glisan Street
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Allentown, Pennsylvania 18103
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170 North 1100 East
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 98508
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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1501 S Potomac St
Aurora, Colorado 80012
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3325 Pocahontas Road
Baker City, Oregon 97814
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
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4950 Essen Lane
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
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440 East Main Street
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Beaufort, South Carolina 29902
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
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Bellingham, Washington 98225
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
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Bend, Oregon 97701
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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100 E Idaho St
Boise, Idaho 83712
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Bolivar, Missouri 65613
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Bonne Terre, Missouri 63628
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1100 Balsam Ave
Boulder, Colorado 80304
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Boulder, Colorado 80303
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915 Highland Blvd
Bozeman, Montana 59715
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7575 Grand River Avenue
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Brighton, Michigan 48114
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Bronx, New York 10467
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Bronx, New York 10461
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Bryan, Texas 77802
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
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Burien, Washington 98166
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Burlington, Wisconsin 53105
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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3123 Medical Dr
Caldwell, Idaho 83605
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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1600 South Canton Center Road
Canton, Michigan 48188
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1600 South Canton Center Road
Canton, Michigan 48188
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
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401 North Hooper Street
Caro, Michigan 48723
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Carterville, Illinois 62918
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
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Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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1303 North Main Street
Cedar City, Utah 84721
(435) 868-5680
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Centerville, Ohio 45459
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Centerville, Ohio 45459
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Centralia, Illinois 62801
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Centralia, Washington 98531
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chattanooga, Tennessee 37404
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775 South Main Street
Chelsea, Michigan 48118
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14650 East Old US Highway 12
Chelsea, Michigan 48118
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Cheyenne, Wyoming 82001
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
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Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
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Phone: 800-782-8581
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Cincinnati, Ohio 45242
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Cincinnati, Ohio 45220
Principal Investigator: Richard L. Deming
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Cincinnati, Ohio 45236
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Cincinnati, Ohio 45255
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Cincinnati, Ohio 45247
Principal Investigator: Richard L. Deming
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
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Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, Oregon 97015
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
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31500 Telegraph Road
Clarkston, Michigan 48346
Principal Investigator: Philip J. Stella
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12495 University Ave
Clive, Iowa 50325
(515) 358-9700
Principal Investigator: Richard L. Deming
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Mercy Cancer Center - West Lakes When it comes to cancer care, there
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Clive, Iowa 50325
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Cody, Wyoming 82414
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Coeur d'Alene, Idaho 83814
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1936 West Poplar Avenue
Collierville, Tennessee 38017
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1500 West Poplar Avenue
Collierville, Tennessee 38017
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
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Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, Colorado 80907
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