AzTrials
AzTrials

Stage I Colon Cancer AJCC v8NCT03516942

Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment

An observational study of Stage I Colon Cancer AJCC v8 and Stage I Rectal Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group at 716 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Quality-of-Life Assessment and Questionnaire Administration
How many people
565 participants
Where
716 sitesUnited States
Study dates
11 Jun 2018to 1 Sep 2028
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients from a gastroenterology, surgical oncology, radiation oncology, or medical oncology clinic with newly diagnosed colon or rectal cancer are potential candidates for the study. Subjects must enroll within 60 days of their diagnostic biopsy or curative-intent surgery and prior to any chemotherapy and/or radiation

Who may be able to join

  • Patients must have a life expectancy of >= 24 months
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
  • Patients must have a newly diagnosed colon or rectal cancer (initial diagnosis, either a biopsy or curative surgery, whichever is most recent) within 60 days of registration and have not yet received radiation or chemotherapy
  • Patients must have stage I, II, or III disease at the time of enrollment and will be treated with curative-intent; this can be defined either clinically or pathologically if they have already undergone surgery; for staging of both colon and rectal cancer, the definition of stage I-III is based on the seventh edition (2010) or an updated version of the tumor, node, metastasis (TNM) staging system
  • Patients are not eligible if they are already enrolled on a treatment clinical trial at the time of registration; they can remain on the study if they subsequently enroll on a treatment clinical trial during the study time period
  • Patients who choose to not receive radiation and/or chemotherapy after a curative-intent surgery are eligible to participate
Show all 9Show fewer
  • Patients with a history of previous malignancy (except non-melanoma skin or cervical in-situ cancer) treated (with either surgery, chemotherapy, and/or radiation) within the last 3 years are not eligible
  • Patients must be able to complete questionnaires in English
  • Patients must sign and give written informed consent in accordance with institutional and federal guidelines

Who cannot join

None listed.

Trial locations and contacts

716 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hawaii Cancer Care - Savio

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Mission Hospital

    Asheville, North Carolina, 28801

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • Our Lady of the Lake Physicians Group - Medical Oncology

    Baton Rouge, Louisiana, 70809

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates-Bristol

    Bristol, Virginia, 24201

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • AtlantiCare Health Park-Cape May Court House

    Cape May Court House, New Jersey, 08210

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

  • Northshore Oncology Associates-Covington

    Covington, Louisiana, 70433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC-Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Epic Care-Dublin

    Dublin, California, 94568

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China, Michigan, 48054

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • AtlantiCare Surgery Center

    Egg Harbor, New Jersey, 08234

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • JCHC McCreery Cancer Center

    Fairfield, Iowa, 52556

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Beaumont Hospital - Farmington Hills

    Farmington Hills, Michigan, 48336

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Trinity Regional Medical Center

    Fort Dodge, Iowa, 50501

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Fresno Cancer Center

    Fresno, California, 93720

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • William Beaumont Hospital-Grosse Point

    Grosse Pointe, Michigan, 48230

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Michigan Breast Specialists-Grosse Pointe Woods

    Grosse Pointe Woods, Michigan, 48236

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • 21st Century Oncology-Henderson

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

  • Island Urology

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent

This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate the change in level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

SECONDARY OBJECTVIES:

  1. Evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

II. Evaluate the change in level of self-reported financial burden and employment limitations from baseline (within 60 days of diagnosis) to 3, 6, and 12 months after diagnosis of colon or rectal cancer treated with curative-intent.

III. Evaluate long term outcomes at 24 months after diagnosis including financial burden, employment limitations and adherence to clinical follow-up guidelines.

IV. Evaluate the change of quality-of-life outcome (QoL) from baseline to 12 months and its association with predictors.

  1. Evaluate the change in level of self-reported financial burden from baseline to 12 months using alternate measures of financial burden (i.e. impact of cost questions and single item from European Organization for Research and Treatment of Cancer [EORTC] questionnaire [Q]30).

OUTLINE:

Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.

Being tested
Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03516942
Study groupRoleWhat they receive
Observational (questionnaire)Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comprehensive Score for Financial Toxicity (COST)

    The Comprehensive Score for Financial Toxicity (COST) COST is an 11-item patient-reported outcome (PRO) of financial hardship that uses a 7-day time window and 5-point Likert response scale (ranging from 0, indicating not at all, to 4, very much). Higher COST scores (range, 0-44) represent better financial well-being.

    The primary objective is to evaluate the change in the level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months from study registration. (12 mo - baseline)

    Measured: Baseline and 12 months after cancer diagnosis

Secondary outcomes (8)

  1. Reported Access and Utilization of Financial Services

    Will evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent. Will be assessed by Consumer Based Cancer Care Value Index (CCVI). For the continuous item variable, will conduct the paired t test to examine the difference if the distribution is normal. If not normally distributed, Wilcoxon signed rank test will be used. For the categorical item variable, the paired proportion test (e.g., McNemar test) will be used instead. The association between CCVI and COST measures will be evaluated using the Pearson or Spearman correlation coefficient.

    Measured: Up to 12 months

  2. Change in Level of Self-reported Employment Limitations

    Change in level of self-reported employment limitations from baseline to 6, 12 and 24 months after study registration will be assessed by Work Productivity and Activity Impairment Questionnaire for a Specific Health Problem (WPAI:SHP). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows:

    Questions:

    1. = currently employed
    2. = hours missed due to specified problem
    3. = hours missed other reasons
    4. = hours actually worked
    5. = degree problem affected productivity while working
    6. = degree problem affected regular activities

    Scores:

    Multiply scores by 100 to express in percentages.

    Percent work time missed due to problem: Q2/(Q2+Q4)

    Percent impairment while working due to problem: Q5/10

    Percent overall work impairment due to problem:

    Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))x(Q5/10)]

    Percent activity impairment due to problem: Q6/10

    Measured: Baseline, 6, 12, and 24 months after cancer diagnosis

  3. Level of Self-reported Employment Limitations (Dichotomized)

    Change in level of self-reported employment limitations from baseline to 6, 12 and 24 months after study registration will be assessed by Work Productivity and Activity Impairment Questionnaire for a Specific Health Problem (WPAI:SHP). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. These outcomes were further dichotomized at 50%, such that Impairment > 50% was considered impaired and Impairment <=50% was not-impaired

    Measured: Baseline, 6, 12, and 24 months after cancer diagnosis

  4. Long Term Outcomes After Diagnosis for Adherence

    Will evaluate long term outcomes at 24 months after diagnosis for adherence to clinical follow-up guidelines. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

    Measured: At 24 months

  5. Long Term Outcomes After Diagnosis for Financial Burden

    Will evaluate long term outcomes at 24 months after diagnosis for financial burden. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time and also the effects of cancer type, stage, treatment plan and demographics, etc. on financial burden. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

    Measured: At 24 months

  6. Long Term Outcomes After Diagnosis for Employment Limitations

    Will evaluate long term outcomes at 24 months after diagnosis for employment limitations. Specially, linear (or generalized linear) mixed model will be fit to study the change in the mean response over time. In case the changes in the mean response over time are not linear, the quadratic trends or non-linear trends via spline may be considered in the modeling. Interactions will be evaluated as well.

    Measured: At 24 months

  7. Change of Quality-of-life (QoL) Outcome

    Will evaluate the change of QoL from baseline to 12 months and its association with predictors. Will be evaluated by Functional Assessment of Cancer Therapy-General.

    Measured: Baseline up to 12 months

  8. Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC]

    Financial Burden was evaluated using a single item from European Organization for Research and Treatment of Cancer Questionnaire 30 [EORT30]) with responses for both baseline and 12 months

    EORTC30 question:

    Has your physical condition or medical treatment caused you financial difficulties?

    • Not at all
    • A little
    • Quite a bit
    • Very much with higher values indicating greater financial difficulty (burden) Responses were dichotomized into No difficulty ("Not at All" ) and some difficulty ( "A little", "Quite a bit", or "Very much")

    Measured: Baseline and12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2018
  2. Study start11 Jun 2018
  3. Primary completion13 Oct 2021
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03516942
Sponsor's protocol ID
EAQ162CD
Other IDs
NCI-2018-00151, EAQ162CD, ECOG-ACRIN-EAQ162CD, ECOG-ACRIN-EAQ162CD, U10CA180820, UG1CA189828
Status last verified
Sep 2026
First submitted
24 Apr 2018
Last updated
25 Sep 2026
Data monitoring committee
Yes

Publications

  • Sadigh G, Duan F, An N, Gareen ID, Sicks J, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Taylor MA, Park E, Wagner LI, Kircher SM, Carlos RC. Financial Hardship Among Patients With Early-Stage Colorectal Cancer. JAMA Netw Open. 2024 Sep 3;7(9):e2431967. doi: 10.1001/jamanetworkopen.2024.31967.

    PubMed 39287948

  • Kircher S, Duan F, An N, Gareen IF, Sicks JD, Sadigh G, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Park ER, Wagner LI, Carlos RC. Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer. JAMA Netw Open. 2024 Jan 2;7(1):e2350844. doi: 10.1001/jamanetworkopen.2023.50844.

    PubMed 38194233

Questions about this trial

What is this clinical trial studying?

An observational study of Stage I Colon Cancer AJCC v8 and Stage I Rectal Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group at 716 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 716 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comprehensive Score for Financial Toxicity (COST) (time frame: Baseline and 12 months after cancer diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03516942, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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