E-Mindfulness Approaches for Living After Breast Cancer
HEAL-ABC
Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC
4 other identifiers
interventional
402
2 countries
299
Brief Summary
NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jun 2025
299 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
June 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2030
April 23, 2026
April 1, 2026
3.7 years
December 19, 2024
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups
The Center for Epidemiologic Studies-Depression (CES-D) score. The score is calculated as the sum of the points for all 10 items. The score range is 0-30 and a score of 10 or greater is considered depressed.
2 weeks post-intervention
Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups
The Center for Epidemiologic Studies-Depression (CES-D) score. The score is calculated as the sum of the points for all 10 items. The score range is 0-30 and a score of 10 or greater is considered depressed.
2 weeks post-intervention
Secondary Outcomes (4)
Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups over time.
3-6 months post-intervention
Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups over time.
3-6 months post-intervention
Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups.
6 months post-intervention
Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups.
6 months post-intervention
Study Arms (3)
Mindfulness (MAPs) Live Online
EXPERIMENTALParticipants assigned to MAPs Live Online (MAPs LO) will be asked to attend 2-hour group sessions once a week for 6 weeks conducted live online over Zoom. Both English and Spanish language participants will be randomized to Arm 1. Sessions will be conducted on an encrypted internet connection and recorded for quality assurance and intervention fidelity. Participants who do not have a home computer, smartphone, tablet, or internet to access the Zoom sessions will have a tablet and hotspot provided by the UCLA research team. Each session provides structured lessons and guided exercises in mindfulness as well as opportunities for reflection and group discussion. Exercises include breath, body, and sound meditations; eating and walking meditations; managing pain; working with difficult thoughts and emotions; and cultivating loving kindness. Home practice is a key component of MAPs, and participants will be instructed to practice mindfulness techniques daily, beginning with 5 minutes
Mindfulness (MAPs) Digital App
EXPERIMENTALParticipants assigned to this condition will be asked to access the MAPs App on their home computer, smartphone, or study supplied tablet over the 6-week intervention period. This will be provided by the UCLA research team. Only English language speakers will be assigned to Arm 2, as the app is currently available only in English at this time. Participants who do not have a home computer, smartphone, tablet, or internet to access the digital app will be provided with a tablet and hotspot by the UCLA research team. The MAPs App translates the content of the MAPs intervention into an app-based format, with lessons, exercises, and guided discussions from the six 2-hour sessions separated into shorter micro-sessions. The digital program is sequential with new content and exercises building on previous sessions. Lessons and other materials are gradually unlocked as participants progress through the program. Engagement with the MAPs App will be tracked to determine "dose" of the inte
Meditation Only Control Group
ACTIVE COMPARATORThe participants assigned to this condition will be provided with access to guided audio mindfulness meditations developed by the UCLA MARC (Mindfulness Awareness Research Center) and available on an app. Both English and Spanish speakers will be assigned to Arm 3, and the meditations will be available in both languages. Participants who do not have a home computer, smartphone, tablet, or internet to access the meditations will be provided with a tablet and hotspot by the UCLA research team. Use of the meditations will be tracked to determine "dose" of the intervention received. All three study groups will have access to the UCLA MARC mindfulness meditation app throughout the study duration out to 6 months of follow-up.
Interventions
Exercises include breath, body, and sound meditations; eating and walking meditations; managing pain; working with difficult thoughts and emotions; and cultivating loving kindness. Home practice is a key component of MAPs, and participants will be instructed to practice mindfulness techniques daily, beginning with 5 minutes daily and increasing to 20 minutes daily using guided meditations. Attendance in the group sessions and home practice will be tracked to determine "dose" of the intervention received.
The digital program is sequential with new content and exercises building on previous sessions. Lessons and other materials are gradually unlocked as participants progress through the program. Engagement with the MAPs App will be tracked to determine "dose" of the intervention received.
Use of the meditations will be tracked to determine "dose" of the intervention received.
Eligibility Criteria
You may qualify if:
- The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.
- The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.
- The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
- The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).
- Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)
- Participant must be able to understand, speak, read, and write in English or Spanish.
- Participant must be willing to participate in a 6-week program to receive training in mindfulness.
- Participant must be able to use a smartphone, tablet, or other digital device.
- Sex assigned at birth must be female.
You may not qualify if:
- Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .
- Any history or current evidence of recurrent or metastatic breast cancer.
- Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
- Currently pregnant or planning to become pregnant in the near future.
- Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (299)
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301, United States
Marshall Cancer Center
Cameron Park, California, 95682, United States
Enloe Medical Center
Chico, California, 95926, United States
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, 92627, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Washington Hospital
Fremont, California, 94538, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Salinas Valley Memorial
Salinas, California, 93901, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
UCI Health - Yorba Linda
Yorba Linda, California, 92886, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Halifax Health Medical Center-Centers for Oncology
Daytona Beach, Florida, 32114, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Emory Decatur Hospital
Decatur, Georgia, 30033, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Rush MD Anderson Cancer Center at Rush Lisle
Lisle, Illinois, 60532, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523, United States
Rush MD Anderson Cancer Center at Rush Oak Park
Oak Park, Illinois, 60304, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
OSF Saint Anthony Medical Center
Rockford, Illinois, 61108, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
UI Healthcare Mission Cancer and Blood - Pella
Pella, Iowa, 50219, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
UM Capital Region Medical Center
Largo, Maryland, 20774, United States
UM Saint Joseph Medical Center
Towson, Maryland, 21204, United States
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland, 21157, United States
Beverly Hospital
Beverly, Massachusetts, 01915, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Lahey Medical Center-Peabody
Peabody, Massachusetts, 01960, United States
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801, United States
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
MyMichigan Medical Center Gladwin
Gladwin, Michigan, 48624, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
MyMichigan Medical Center Midland
Midland, Michigan, 48670, United States
MyMichigan Medical Center Mount Pleasant
Mount Pleasant, Michigan, 48858, United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901, United States
Mississippi Baptist Medical Center
Jackson, Mississippi, 39202, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Ocean University Medical Center
Brick, New Jersey, 08724, United States
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, 08210, United States
AtlantiCare Surgery Center
Egg Harbor, New Jersey, 08234, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Summit Health - Florham Park Campus
Florham Park, New Jersey, 07932, United States
Bayshore Community Hospital
Holmdel, New Jersey, 07733, United States
Southern Ocean County Medical Center
Manahawkin, New Jersey, 08050, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, 07450, United States
Mount Sinai Queens
Astoria, New York, 11102, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Garnet Health Medical Center
Middletown, New York, 10940, United States
Mount Sinai Union Square
New York, New York, 10003, United States
Mount Sinai Chelsea
New York, New York, 10011, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Cone Health MedCenter Asheboro
Asheboro, North Carolina, 27205, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, 27410, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
Memorial Hospital
Marysville, Ohio, 43040, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Saint Charles Health System-Redmond
Redmond, Oregon, 97756, United States
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania, 17201, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601, United States
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Redeemer Health
Meadowbrook, Pennsylvania, 19046, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050, United States
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, 15666, United States
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, 15642, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Chester County Hospital
West Chester, Pennsylvania, 19380, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Beaufort Memorial Hospital
Beaufort, South Carolina, 29902, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
Inova Alexandria Hospital
Alexandria, Virginia, 22304, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Inova Loudoun Hospital
Leesburg, Virginia, 20176, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Bon Secours Richmond Community Hospital
Richmond, Virginia, 23223, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226, United States
Virginia Cancer Institute
Richmond, Virginia, 23229, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033, United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956, United States
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Memorial Hospital of Sweetwater County
Rock Springs, Wyoming, 82901, United States
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
PROncology
San Juan, 00927, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Norman Wolmark, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
December 27, 2024
Study Start
June 27, 2025
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
February 28, 2030
Last Updated
April 23, 2026
Record last verified: 2026-04