- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05108298
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate feasibility and acceptability of completing patient reported outcomes (PROs) among AYAs randomized to Choice PRO versus (vs) Fixed PRO.
EXPLORATORY OBJECTIVES:
I. To evaluate AYAs' health-related quality of life (HRQOL) priorities and HRQOL PRO trajectories.
II. To evaluate access to and utilization of psychosocial and financial resources using items from the Consumer-Based Cancer Care Value Index (CCVI).
III. To summarize AYAs' preferences for how their PRO data should be shared with them, their families, and/or their providers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (CHOICE PRO): Patients rank 15 HRQOL domains from most important to least important and choose 5 HRQOL domains to complete over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
ARM II (FIXED PRO): Patients rank 15 HRQOL domains from most important to least important and complete 5 pre-selected HRQOL domains over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Alaska
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Fairbanks, Alaska, United States, 99701
- Fairbanks Memorial Hospital
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Arizona
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Kingman, Arizona, United States, 86401
- Kingman Regional Medical Center
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Phoenix, Arizona, United States, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, United States, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, United States, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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Little Rock, Arkansas, United States, 72205
- CARTI Cancer Center
-
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California
-
Arroyo Grande, California, United States, 93420
- PCR Oncology
-
Arroyo Grande, California, United States, 93420
- Mission Hope Medical Oncology - Arroyo Grande
-
Carmichael, California, United States, 95608
- Mercy San Juan Medical Center
-
Carmichael, California, United States, 95608
- Mercy Cancer Center - Carmichael
-
Dublin, California, United States, 94568
- Epic Care-Dublin
-
Elk Grove, California, United States, 95758
- Mercy Cancer Center - Elk Grove
-
Emeryville, California, United States, 94608
- Bay Area Breast Surgeons Inc
-
Emeryville, California, United States, 94608
- Epic Care Partners in Cancer Care
-
Martinez, California, United States, 94553-3156
- Contra Costa Regional Medical Center
-
Merced, California, United States, 95340
- Mercy Cancer Center
-
Oakland, California, United States, 94609
- Bay Area Tumor Institute
-
Rocklin, California, United States, 95765
- Mercy Cancer Center - Rocklin
-
Sacramento, California, United States, 95816
- Mercy Cancer Center - Sacramento
-
San Luis Obispo, California, United States, 93401
- Pacific Central Coast Health Center-San Luis Obispo
-
Santa Maria, California, United States, 93444
- Mission Hope Medical Oncology - Santa Maria
-
Walnut Creek, California, United States, 94597
- Epic Care Cyberknife Center
-
Walnut Creek, California, United States, 94598
- BASS Medical Group - Lennon
-
Woodland, California, United States, 95695
- Woodland Memorial Hospital
-
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Colorado
-
Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers-Aurora
-
Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
-
Boulder, Colorado, United States, 80303
- Boulder Community Foothills Hospital
-
Boulder, Colorado, United States, 80304
- Rocky Mountain Cancer Centers-Boulder
-
Centennial, Colorado, United States, 80112
- Rocky Mountain Cancer Centers - Centennial
-
Colorado Springs, Colorado, United States, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers-Penrose
-
Colorado Springs, Colorado, United States, 80923
- Saint Francis Cancer Center
-
Denver, Colorado, United States, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver, Colorado, United States, 80220
- Rose Medical Center
-
Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers-Rose
-
Denver, Colorado, United States, 80218
- Colorado Blood Cancer Institute
-
Denver, Colorado, United States, 80209
- The Women's Imaging Center
-
Denver, Colorado, United States, 80220
- Western Surgical Care
-
Denver, Colorado, United States, 80210
- AdventHealth Porter
-
Durango, Colorado, United States, 81301
- Mercy Medical Center
-
Durango, Colorado, United States, 81301
- CommonSpirit Cancer Center Mercy
-
Englewood, Colorado, United States, 80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood, Colorado, United States, 80113
- Swedish Medical Center
-
Englewood, Colorado, United States, 80113
- Rocky Mountain Cancer Centers - Swedish
-
Englewood, Colorado, United States, 80113
- The Melanoma and Skin Cancer Institute
-
Greeley, Colorado, United States, 80631
- Banner North Colorado Medical Center
-
Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers-Lakewood
-
Lakewood, Colorado, United States, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
-
Littleton, Colorado, United States, 80120
- Rocky Mountain Cancer Centers-Littleton
-
Littleton, Colorado, United States, 80122
- AdventHealth Littleton
-
Lone Tree, Colorado, United States, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Longmont, Colorado, United States, 80501
- Longmont United Hospital
-
Longmont, Colorado, United States, 80501
- Rocky Mountain Cancer Centers-Longmont
-
Loveland, Colorado, United States, 80539
- Banner North Colorado Medical Center - Loveland Campus
-
Parker, Colorado, United States, 80138
- AdventHealth Parker
-
Pueblo, Colorado, United States, 81004
- Saint Mary Corwin Medical Center
-
Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers-Thornton
-
-
Connecticut
-
Stamford, Connecticut, United States, 06904
- Stamford Hospital/Bennett Cancer Center
-
-
Delaware
-
Lewes, Delaware, United States, 19958
- Beebe Medical Center
-
Millville, Delaware, United States, 19967
- Beebe South Coastal Health Campus
-
Newark, Delaware, United States, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, United States, 19713
- Delaware Clinical and Laboratory Physicians PA
-
Newark, Delaware, United States, 19713
- Medical Oncology Hematology Consultants PA
-
Newark, Delaware, United States, 19718
- Christiana Care Health System-Christiana Hospital
-
Rehoboth Beach, Delaware, United States, 19971
- Beebe Health Campus
-
Wilmington, Delaware, United States, 19801
- Christiana Care Health System-Wilmington Hospital
-
-
Georgia
-
Savannah, Georgia, United States, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
-
Illinois
-
Alton, Illinois, United States, 62002
- OSF Saint Anthony's Health Center
-
Aurora, Illinois, United States, 60504
- Rush-Copley Medical Center
-
Bloomington, Illinois, United States, 61704
- Illinois CancerCare-Bloomington
-
Bloomington, Illinois, United States, 61704
- Carle BroMenn Outpatient Center
-
Canton, Illinois, United States, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, United States, 62902
- Memorial Hospital of Carbondale
-
Carterville, Illinois, United States, 62918
- SIH Cancer Institute
-
Carthage, Illinois, United States, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, United States, 62801
- Centralia Oncology Clinic
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
Danville, Illinois, United States, 61832
- Carle at The Riverfront
-
Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, United States, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, United States, 61021
- Illinois CancerCare-Dixon
-
Effingham, Illinois, United States, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, United States, 62401
- Carle Physician Group-Effingham
-
Eureka, Illinois, United States, 61530
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, United States, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, United States, 61401
- Illinois CancerCare-Galesburg
-
Kewanee, Illinois, United States, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, United States, 61455
- Illinois CancerCare-Macomb
-
Mattoon, Illinois, United States, 61938
- Carle Physician Group-Mattoon/Charleston
-
Mount Vernon, Illinois, United States, 62864
- SSM Health Good Samaritan
-
Normal, Illinois, United States, 61761
- Carle Cancer Institute Normal
-
Normal, Illinois, United States, 61761
- Carle BroMenn Medical Center
-
O'Fallon, Illinois, United States, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, United States, 61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin, Illinois, United States, 61554
- Illinois CancerCare-Pekin
-
Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61615
- Illinois CancerCare-Peoria
-
Peru, Illinois, United States, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, United States, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, United States, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, United States, 62702
- Springfield Clinic
-
Springfield, Illinois, United States, 62781
- Springfield Memorial Hospital
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center
-
Urbana, Illinois, United States, 61801
- The Carle Foundation Hospital
-
Washington, Illinois, United States, 61571
- Illinois CancerCare - Washington
-
Yorkville, Illinois, United States, 60560
- Rush-Copley Healthcare Center
-
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Iowa
-
Ames, Iowa, United States, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, United States, 50010
- McFarland Clinic - Ames
-
Ankeny, Iowa, United States, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
-
Boone, Iowa, United States, 50036
- McFarland Clinic - Boone
-
Carroll, Iowa, United States, 51401
- Saint Anthony Regional Hospital
-
Cedar Rapids, Iowa, United States, 52403
- Mercy Hospital
-
Cedar Rapids, Iowa, United States, 52403
- Oncology Associates at Mercy Medical Center
-
Clive, Iowa, United States, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, United States, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Council Bluffs, Iowa, United States, 51503
- Alegent Health Mercy Hospital
-
Creston, Iowa, United States, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, United States, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, United States, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Fort Dodge, Iowa, United States, 50501
- McFarland Clinic - Trinity Cancer Center
-
Fort Dodge, Iowa, United States, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
-
Jefferson, Iowa, United States, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, United States, 50158
- McFarland Clinic - Marshalltown
-
Waukee, Iowa, United States, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
-
West Des Moines, Iowa, United States, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, United States, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Garden City, Kansas, United States, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, United States, 67530
- Central Care Cancer Center - Great Bend
-
Pittsburg, Kansas, United States, 66762
- Mercy Hospital Pittsburg
-
-
Kentucky
-
Bardstown, Kentucky, United States, 40004
- CommonSpirit Saint Joseph Hospital - Bardstown
-
Corbin, Kentucky, United States, 40701
- Commonwealth Cancer Center-Corbin
-
Lexington, Kentucky, United States, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, United States, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
-
Lexington, Kentucky, United States, 40504
- CommonSpirit Saint Joseph Hospital - Lexington
-
London, Kentucky, United States, 40741
- CommonSpirit Saint Joseph Hospital London
-
Louisville, Kentucky, United States, 40202
- Jewish Hospital
-
Louisville, Kentucky, United States, 40245
- UofL Health Medical Center Northeast
-
Louisville, Kentucky, United States, 40215
- Saints Mary and Elizabeth Hospital
-
Mount Sterling, Kentucky, United States, 40353
- CommonSpirit Saint Joseph Hospital Mount Sterling
-
Paducah, Kentucky, United States, 42003
- Mercy Health - Paducah Cancer Center
-
Shepherdsville, Kentucky, United States, 40165
- Jewish Hospital Medical Center South
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- University Medical Center New Orleans
-
New Orleans, Louisiana, United States, 70112
- Louisiana State University Health Science Center
-
-
Maryland
-
Elkton, Maryland, United States, 21921
- Christiana Care - Union Hospital
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
Lowell, Massachusetts, United States, 01854
- Lowell General Hospital
-
Stoneham, Massachusetts, United States, 02180
- Tufts Medical Center Cancer Center Stoneham
-
-
Minnesota
-
Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, United States, 55337
- Minnesota Oncology - Burnsville
-
Cambridge, Minnesota, United States, 55008
- Cambridge Medical Center
-
Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
-
Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, United States, 55432
- Unity Hospital
-
Maple Grove, Minnesota, United States, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55454
- Health Partners Inc
-
Monticello, Minnesota, United States, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, United States, 56073
- New Ulm Medical Center
-
Princeton, Minnesota, United States, 55371
- Fairview Northland Medical Center
-
Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, United States, 55101
- Regions Hospital
-
Saint Paul, Minnesota, United States, 55102
- United Hospital
-
Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, United States, 55082
- Lakeview Hospital
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, United States, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, United States, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Ballwin, Missouri, United States, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, United States, 65613
- Central Care Cancer Center - Bolivar
-
Branson, Missouri, United States, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, United States, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, United States, 63703
- Mercy Cancer Center - Cape Girardeau
-
Farmington, Missouri, United States, 63640
- Parkland Health Center - Farmington
-
Jefferson City, Missouri, United States, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, United States, 64804
- Freeman Health System
-
Joplin, Missouri, United States, 64804
- Mercy Hospital Joplin
-
Osage Beach, Missouri, United States, 65065
- Lake Regional Hospital
-
Rolla, Missouri, United States, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, United States, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, United States, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, United States, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, United States, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, United States, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, United States, 63128
- Mercy Hospital South
-
Sullivan, Missouri, United States, 63080
- Missouri Baptist Sullivan Hospital
-
Washington, Missouri, United States, 63090
- Mercy Hospital Washington
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, United States, 68847
- CHI Health Good Samaritan
-
Lincoln, Nebraska, United States, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, United States, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, United States, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, United States, 68130
- Alegent Health Lakeside Hospital
-
Papillion, Nebraska, United States, 68046
- Midlands Community Hospital
-
-
Nevada
-
Carson City, Nevada, United States, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, United States, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, United States, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, United States, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, United States, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, United States, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, United States, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, United States, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, United States, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, United States, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, United States, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, United States, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, United States, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, United States, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, United States, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, United States, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, United States, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, United States, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, United States, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, United States, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, United States, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, United States, 89102
- Desert West Surgery
-
Las Vegas, Nevada, United States, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, United States, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, United States, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, United States, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, United States, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, United States, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, United States, 89169
- University Cancer Center
-
Las Vegas, Nevada, United States, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, United States, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, United States, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, United States, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, United States, 89502
- Renown Regional Medical Center
-
Reno, Nevada, United States, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, United States, 89509
- Radiation Oncology Associates
-
Reno, Nevada, United States, 89511
- Cancer Care Specialists - Reno
-
Reno, Nevada, United States, 89502
- University of Nevada at Reno Veterans Affairs Medical Center
-
-
New Jersey
-
Teaneck, New Jersey, United States, 07666
- Holy Name Hospital
-
-
New York
-
The Bronx, New York, United States, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, United States, 10467
- Children's Hospital at Montefiore
-
The Bronx, New York, United States, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, United States, 10461
- Montefiore Medical Center-Weiler Hospital
-
-
North Carolina
-
Gastonia, North Carolina, United States, 28054
- CaroMont Regional Medical Center
-
Lincolnton, North Carolina, United States, 28092
- CaroMont Health - Lincoln Cancer Center
-
-
Ohio
-
Belpre, Ohio, United States, 45714
- Strecker Cancer Center-Belpre
-
Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, United States, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, United States, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, United States, 45255
- TriHealth Cancer Institute-Anderson
-
Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, United States, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, United States, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, United States, 43228
- Doctors Hospital
-
Columbus, Ohio, United States, 43213
- Mount Carmel East Hospital
-
Columbus, Ohio, United States, 43215
- Grant Medical Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Delaware, Ohio, United States, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
-
Dublin, Ohio, United States, 43016
- Dublin Methodist Hospital
-
Dublin, Ohio, United States, 43016
- Columbus Oncology and Hematology Associates
-
Gahanna, Ohio, United States, 43230
- Central Ohio Breast and Endocrine Surgery
-
Grove City, Ohio, United States, 43123
- Mount Carmel Grove City Hospital
-
Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
-
Lima, Ohio, United States, 45801
- Saint Rita's Medical Center
-
Mansfield, Ohio, United States, 44903
- OhioHealth Mansfield Hospital
-
Marietta, Ohio, United States, 45750
- Marietta Memorial Hospital
-
Marion, Ohio, United States, 43302
- OhioHealth Marion General Hospital
-
Marysville, Ohio, United States, 43040
- Memorial Hospital
-
Mount Vernon, Ohio, United States, 43050
- Knox Community Hospital
-
New Albany, Ohio, United States, 43054
- Mount Carmel New Albany Surgical Hospital
-
Newark, Ohio, United States, 43055
- Licking Memorial Hospital
-
Newark, Ohio, United States, 43055
- Newark Radiation Oncology
-
Perrysburg, Ohio, United States, 43551
- Mercy Health - Perrysburg Hospital
-
Portsmouth, Ohio, United States, 45662
- Southern Ohio Medical Center
-
Toledo, Ohio, United States, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, United States, 43608
- Mercy Health - Saint Vincent Hospital
-
Toledo, Ohio, United States, 43623
- Mercy Health Sylvania Radiation Oncology Center
-
Westerville, Ohio, United States, 43081
- Saint Ann's Hospital
-
Wilmington, Ohio, United States, 45177
- Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
-
Zanesville, Ohio, United States, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73120
- Mercy Hospital Oklahoma City
-
-
Pennsylvania
-
Chadds Ford, Pennsylvania, United States, 19317
- Christiana Care Health System-Concord Health Center
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
-
East Norriton, Pennsylvania, United States, 19401
- Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
-
Hazleton, Pennsylvania, United States, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Lewisburg, Pennsylvania, United States, 17837
- Geisinger Medical Oncology-Lewisburg
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
-
Pottsville, Pennsylvania, United States, 17901
- Geisinger Cancer Services-Pottsville
-
Scranton, Pennsylvania, United States, 18510
- Community Medical Center
-
Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- AnMed Health Cancer Center
-
Bluffton, South Carolina, United States, 29910
- Saint Joseph's/Candler - Bluffton Campus
-
Boiling Springs, South Carolina, United States, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Easley, South Carolina, United States, 29640
- Prisma Health Cancer Institute - Easley
-
Gaffney, South Carolina, United States, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, United States, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, United States, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, United States, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, United States, 29605
- Prisma Health Greenville Memorial Hospital
-
Greer, South Carolina, United States, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, United States, 29651
- Gibbs Cancer Center-Pelham
-
Seneca, South Carolina, United States, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
-
Union, South Carolina, United States, 29379
- SMC Center for Hematology Oncology Union
-
-
Tennessee
-
Kingsport, Tennessee, United States, 37660
- Ballad Health Cancer Care - Kingsport
-
-
Texas
-
Bryan, Texas, United States, 77802
- Saint Joseph Regional Cancer Center
-
Fort Worth, Texas, United States, 76104
- Tarrant County Hospital District/JPS Health Network
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
-
-
Virginia
-
Bristol, Virginia, United States, 24201
- Ballad Health Cancer Care - Bristol
-
Norton, Virginia, United States, 24273
- Ballad Health Cancer Care - Norton
-
-
Washington
-
Bellevue, Washington, United States, 98004
- Overlake Medical Center
-
Burien, Washington, United States, 98166
- Highline Medical Center-Main Campus
-
Enumclaw, Washington, United States, 98022
- Saint Elizabeth Hospital
-
Federal Way, Washington, United States, 98003
- Saint Francis Hospital
-
Lakewood, Washington, United States, 98499
- Saint Clare Hospital
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Port Townsend, Washington, United States, 98368
- Jefferson Healthcare
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Renton, Washington, United States, 98055
- Valley Medical Center
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Silverdale, Washington, United States, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
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Tacoma, Washington, United States, 98405
- Franciscan Research Center-Northwest Medical Plaza
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Yakima, Washington, United States, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital Cancer Center Green Bay
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Green Bay, Wisconsin, United States, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
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New Richmond, Wisconsin, United States, 54017
- Cancer Center of Western Wisconsin
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Oconto Falls, Wisconsin, United States, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
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Sturgeon Bay, Wisconsin, United States, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
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Wyoming
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Cheyenne, Wyoming, United States, 82001
- Cheyenne Regional Medical Center-West
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient must be >= 18 years and =< 39 years of age at registration
- Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration
- Patient must not have a recurrence or second primary cancer
- Patients must not have basal cell skin carcinoma
- Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Patient must have a life expectancy > 24 months
- Patient must be able to complete questionnaires in English or in Spanish
- Patient must have internet access through computer, tablet, or smartphone
- Patient must have an email address
- Patient must have a mobile phone able with text messaging capabilities
- Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact)
- Patient must be able to provide informed consent
Participation in clinical trials is not an exclusionary criterion in EAQ202. Patients may be dually enrolled in EAQ202 as well as in therapeutic trials, including those involving checkpoint inhibitors
- NOTE: We understand that some therapeutic trials may also collect PRO data (e.g., the cross-National Clinical Trials Network [NCTN] S1826 study in which ECOG-ACRIN is participating), thus creating a potential for overburdening patients. We will be attentive to informing all patients of this potential overburdening as they consider a voluntary decision to register for EAQ202. We will coordinate with the PRO chair(s) of the therapeutic studies to ensure that the integrity of the PRO analyses be preserved
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (choice PRO)
Patients rank 15 HRQOL domains from most important to least important and choose 5 HRQOL domains to complete over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
|
Complete questionnaires
Complete questionnaires
Other Names:
|
|
Experimental: Arm II (fixed PRO)
Patients rank 15 HRQOL domains from most important to least important and complete 5 pre-selected HRQOL domains over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
|
Complete questionnaires
Complete questionnaires
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of completing patient reported outcomes (PROs)
Time Frame: At 1 month
|
Will be defined as >= 75% completed PROs at one-month.
Feasibility will be compared between two arms using the two-sample proportion tests based on two binomial distributions.
Fisher's exact method will be used to calculate the p value.
Potential moderators will include sociodemographic information (i.e., Protocol for Responding to & Assessing Patients' Assets, Risks & Experiences [PRAPARE] form, geocoding, etc.), health literacy, adherence boosters (reminder calls, text messages), cancer type, treatment plan, and location of care (inpatient hospital or outpatient clinic setting).
Their effects will be evaluated using the logistic regression method with feasibility modeled as the binary response.
|
At 1 month
|
|
Acceptability of completing PROs
Time Frame: Baseline
|
Will be defined as >= 75% completed PROs at baseline.
Acceptability will be compared between two arms using the two-sample proportion tests based on two binomial distributions.
Fisher's exact method will be used to calculate the p value.
Potential moderators will include sociodemographic information (i.e., PRAPARE form, geocoding, etc.), health literacy, adherence boosters (reminder calls, text messages), cancer type, treatment plan, and location of care (inpatient hospital or outpatient clinic setting).
Their effects will be evaluated using the logistic regression method with acceptability modeled as the binary response.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescent and young adults (AYAs') health-related quality of life (HRQOL) priorities and HRQOL PRO trajectories
Time Frame: Up to 12 months
|
Descriptive statistics (e.g., frequencies, mean, etc.) will be performed to evaluate the importance of the domains at each time point.
The changes over time may be modeled using the generalize linear mixed models (e.g., zero-inflated negative binomial regression to model the ranks with excessive zeros).
To examine changes in Patient Reported Outcomes Measurement Information System Computer Adaptive Tests over time, will fit linear (or generalized linear) mixed models to model the trajectory of the outcomes by group and time accounting for the repeated measures on a subject, using linear contrasts to estimate differences in means by group and by time.
Will plan to perform subgroup analyses by sex, study arm, and minority status.
|
Up to 12 months
|
|
Access to and utilization of psychosocial and financial resources
Time Frame: Up to 12 months
|
Evaluated using items from the Consumer-Based Cancer Care Value Index.
|
Up to 12 months
|
|
AYAs' preferences for how their PRO data should be shared with them, their families, and/or their providers
Time Frame: Up to 12 months
|
Response options will be ranked and will include: trajectories of their scores and change over time, reports comparing their scores to others: age, access to tailored information for self-management strategies, notifications that clinical attention may be needed with referral contact information, reports provided to the medical team, and open-ended text responses.
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John M Salsman, ECOG-ACRIN Cancer Research Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Bone Diseases
- Musculoskeletal Diseases
- Nervous System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Uterine Diseases
- Genital Diseases, Female
- Hematologic Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Colonic Diseases
- Genital Neoplasms, Female
- Skin Diseases
- Breast Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Uterine Cervical Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Uterine Neoplasms
- Neuroendocrine Tumors
- Neoplasms, Connective and Soft Tissue
- Nevi and Melanomas
- Skin Neoplasms
- Thyroid Diseases
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Pyloric Stenosis
- Gastric Outlet Obstruction
- Leukemia
- Colonic Neoplasms
- Breast Neoplasms
- Lymphoma
- Uterine Cervical Neoplasms
- Melanoma
- Sarcoma
- Central Nervous System Neoplasms
- Thyroid Neoplasms
- Bone Neoplasms
- Pyloric Stenosis, Hypertrophic
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- EAQ202 (Other Identifier: CTEP)
- UG1CA189828 (U.S. NIH Grant/Contract)
- NCI-2021-07529 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- ECOG-ACRIN-EAQ202 (Other Identifier: DCP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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