S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Text message reminder
- Registration Number
- NCT01515800
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Measuring how text-message affects treatment compliance in women with breast cancer may help doctors plan the best treatment.
PURPOSE: This randomized trial studies how well text-message works in reducing early discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who underwent breast surgery.
- Detailed Description
OBJECTIVES:
Primary
* To determine the efficacy of a reminder message, sent by text message to mobile phones twice weekly, to improve adherence to adjuvant aromatase inhibitor (AI) therapy as determined by urinary AI levels in women with early-stage hormone-sensitive breast cancer versus usual care.
Secondary
* To compare the effect of a reminder message sent twice weekly to mobile phones as compared to usual care to improve adherence to adjuvant AI therapy according to self-report.
* To explore the efficacy of the text message intervention for reducing early discontinuation as compared to usual care at 12, 24, and 36 months of adjuvant AI therapy in subgroups of breast cancer patients as defined by age group, stage, year of therapy, education, race/ethnicity, teaching hospital versus community hospital, AI-related side effects (as determined by serial questionnaires), insurance status, and prescription co-pay status.
* To explore the reasons for early discontinuation of AI therapy in those who do discontinue in the intervention and control group by querying quality of life as assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) and symptoms and other issues related to hormonal therapy at each follow-up visit, using the Brief Pain Inventory (BPI-SF), and at annual visits the Beliefs about Medicine Questionnaire (BQM) and the Treatment Satisfaction Questionnaire for Medication (TSQM).
* To conduct a sensitivity analysis assessing time to last evidence of adherence.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time on aromatase inhibitor (AI) (\< 12 months vs 12-24 months), and type of AI (anastrozole vs letrozole vs exemestane). Patients are randomized to 1 of 2 intervention arms.
* Arm I: Patients undergo a text message education checklist involving confirmation of cellular telephone capability to receive text messages, how to retrieve and read messages, including a confirmation evaluation, at baseline and at any time a patient obtains a new cellular telephone. Patients then receive a text message twice a week at 8 o'clock in the morning (for each time zone) for up to 3 years.
* Arm II: Patients receive standard follow-up care. Patients undergo urine sample collection at baseline and periodically during study for aromatase inhibitor level analysis and future translational studies.
Patients complete the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES), the Brief Pain Inventory (BPI-SF), Beliefs about Medicine Questionnaire (BQM), and the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaires at baseline and periodically during study. Patients in arm I also complete the Cell Phone and Text Messaging Use Questionnaire at baseline and periodically during study.
In both arms, patients are followed up every 3 months for up to 3 years from registration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 724
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Text message reminder Text message reminder Patients undergo a text message education checklist involving confirmation of cellular telephone capability to receive text messages, how to retrieve and read messages, including a confirmation evaluation, at baseline and at any time a patient obtains a new cellular telephone. Patients then receive a text message twice a week at 8 o'clock in the morning (for each time zone) for up to 3 years. Additionally, patients receive standard follow-up care.
- Primary Outcome Measures
Name Time Method Time to first evidence of adherence failure (discontinuation) Every 3 months after randomization
- Secondary Outcome Measures
Name Time Method Adherence effect of text message compared to usual care using the patient self-report responses to AI Usage form Every 3 months after randomization Relationship between randomized arm and various participant, site and health insurance characteristics Every 3 months after randomization Relationship between randomized arm and the following factors: age group, stage, years of therapy, education, race/ethnicity, teaching hospital versus community hospital, AI-related side effects, insurance status, and prescription co-pay status.
Reasons for early discontinuation of AI therapy among intervention arm and control arm as assessed by quality-of-life questionnaires Every 3 months after randomization Time to last evidence of adherence Every 3 months after randomization
Trial Locations
- Locations (204)
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Kaiser Permanente Medical Center - Redwood City
🇺🇸Redwood City, California, United States
Kaiser Foundation Hospital - San Rafael
🇺🇸San Rafael, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Waverly Hematology Oncology
🇺🇸Cary, North Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Clackamas Radiation Oncology Center
🇺🇸Clackamas, Oregon, United States
Cancer Centers of the Carolinas - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Kaiser Permanente Medical Center - Walnut Creek
🇺🇸Walnut Creek, California, United States
Castle Medical Center
🇺🇸Kailua, Hawaii, United States
California Cancer Center - Woodward Park Office
🇺🇸Fresno, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
Kaiser Permanente Medical Center - Santa Teresa
🇺🇸San Jose, California, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Kaiser Permanente Medical Facility - Stockton
🇺🇸Stockton, California, United States
Kaiser Permanente Fresno Medical Center
🇺🇸Fresno, California, United States
Oncare Hawaii, Incorporated - Pali Momi
🇺🇸'Aiea, Hawaii, United States
Kapiolani Medical Center at Pali Momi
🇺🇸'Aiea, Hawaii, United States
Kaiser Permanente Medical Center - Santa Rosa
🇺🇸Santa Rosa, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸Santa Clara, California, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Kaiser Permanente Medical Center - South San Francisco
🇺🇸South San Francisco, California, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Falck Cancer Center at Arnot Ogden Medical Center
🇺🇸Elmira, New York, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
🇺🇸Albuquerque, New Mexico, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Highland Clinic
🇺🇸Shreveport, Louisiana, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
🇺🇸Southfield, Michigan, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Mercy General Health Partners
🇺🇸Muskegon, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Lovelace Medical Center - Downtown
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Southern Ohio Medical Center Cancer Center
🇺🇸Portsmouth, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Air Force Base, Ohio, United States
Cancer Centers of the Carolinas - Faris Road
🇺🇸Greenville, South Carolina, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
Kaiser Permanente Medical Center - Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸San Francisco, California, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸Seneca, South Carolina, United States
Spectrum Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
Providence Newberg Medical Center
🇺🇸Newberg, Oregon, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Kaiser Permanente Medical Center - Richmond
🇺🇸Richmond, California, United States
Kauai Medical Clinic
🇺🇸Lihue, Hawaii, United States
Willamette Falls Hospital
🇺🇸Oregon City, Oregon, United States
Bon Secours St. Francis Health System
🇺🇸Greenville, South Carolina, United States
South Sacramento Kaiser-Permanente Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸Sacramento, California, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Kaiser Permanente Health Care - Portland
🇺🇸Portland, Oregon, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente - Deer Valley
🇺🇸Antioch, California, United States
Kaiser Permanente Medical Center - Vacaville
🇺🇸Vacaville, California, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Sherman Hospital
🇺🇸Elgin, Illinois, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Mercy Clinic Cancer and Hematology - Rolla
🇺🇸Rolla, Missouri, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Midwest Hematology Oncology Group, Incorporated
🇺🇸Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Hematology Oncology Associates, PC
🇺🇸Albuquerque, New Mexico, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Cancer Centers of the Carolinas - Greer Medical Oncology
🇺🇸Greer, South Carolina, United States
Cancer Centers of the Carolinas - Grove Commons
🇺🇸Greenville, South Carolina, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Highline Medical Center Cancer Center
🇺🇸Burien, Washington, United States
Island Hospital Cancer Care Center at Island Hospital
🇺🇸Anacortes, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mount Vernon, Washington, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Swedish Medical Center - Issaquah Campus
🇺🇸Issaquah, Washington, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Harrison Poulsbo Hematology and Onocology
🇺🇸Poulsbo, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Woolley, Washington, United States
Evergreen Hematology and Oncology, PS
🇺🇸Spokane, Washington, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
Kuakini Medical Center
🇺🇸Honolulu, Hawaii, United States
Kaiser Permanente - Moanalua Medical Center and Clinic
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States