Know Cancer

forgot password

S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer



- 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.


- 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

- 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.

Inclusion Criteria


- Patients must be women with a diagnosis of histologically confirmed, primary
invasive, hormone-sensitive (estrogen receptor-positive [ER]/progesterone receptor
[PR]-positive) adenocarcinoma of the breast (Stage I, II or III) with no evidence of
recurrent or metastatic disease (M0)

- Patients must have a mobile phone that can receive text messages and must currently
use or be willing to learn to use text messaging


- Patients must be postmenopausal, as defined by at least one of the following:

- ≥ 12 months since the last menstrual period

- Prior bilateral oophorectomy

- Previous hysterectomy with one or both ovaries left in place (or previous
hysterectomy in which documentation of bilateral oophorectomy is unavailable)
AND follicle-stimulating hormone (FSH) values consistent with the institutional
normal values for the postmenopausal state; FSH levels must be obtained within
28 days prior to registration

- Patients must be willing to provide urine specimen to test for the presence of
aromatase inhibitor within 28 days of randomization and at each 3-month clinic visit
for 3 years

- Patients must have the ability to speak and read English

- Patients must have a Zubrod performance status of 0 - 2

- No other prior malignancy (i.e., other than as noted on disease characteristics) is
allowed except for adequately treated basal cell or squamous cell skin cancer, in
situ cervical cancer, or other cancer for which the patient has been disease-free for
> 5 years

- Patients are allowed to participate in another clinical trial as long as it does not
interfere with daily intake of aromatase-inhibitor therapy


- Patients must be post adjuvant chemotherapy (if to be utilized) and primary curative
surgery and must have recovered from all side-effects of the surgery

- Trastuzumab (Herceptin) given alone after cytotoxic chemotherapy is considered
adjuvant chemotherapy; patients would be eligible upon completion of Herceptin
as long as the other eligibility criteria are met

- Patients must be currently taking an aromatase inhibitor (AI), have completed at
least one month of AI therapy, be within the first 5 years of planned AI therapy, and
have at least 3 years remaining before completion of planned AI therapy

Exclusion criteria: Insufficient evidence of post-menopausal status; metastatic or
recurent disease; currently receiving chemotherapy.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Time to first evidence of adherence failure (discontinuation)

Outcome Time Frame:

Every 3 months after randomization

Safety Issue:


Principal Investigator

Alfred I. Neugut, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2012

Completion Date:

March 2018

Related Keywords:

  • Breast Cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-positive breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
CCOP - Greenville Greenville, South Carolina  29615
LDS Hospital Salt Lake City, Utah  84143
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Winthrop University Hospital Mineola, New York  11501
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara, California  95051-5386
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Kaiser Permanente - Fremont Fremont, California  94538
Kaiser Permanente Medical Center - Hayward Hayward, California  94545
Kaiser Permanente Medical Center - Redwood City Redwood City, California  94063
Kaiser Permanente Medical Center - Richmond Richmond, California  94801
Kaiser Permanente Medical Center - Roseville Roseville, California  95661
South Sacramento Kaiser-Permanente Medical Center Sacramento, California  95823
Kaiser Permanente Medical Center - Santa Teresa San Jose, California  95119
Kaiser Foundation Hospital - San Rafael San Rafael, California  94903
Kaiser Permanente Medical Center - Santa Rosa Santa Rosa, California  95403
Kaiser Permanente Medical Center - South San Francisco South San Francisco, California  94080
Kaiser Permanente Medical Facility - Stockton Stockton, California  95210
Kaiser Permanente Medical Center - Walnut Creek Walnut Creek, California  94596
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport, Louisiana  71130-3932
Mecosta County Medical Center Big Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield, Michigan  48075
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Highland Hospital of Rochester Rochester, New York  14620
Iredell Memorial Hospital Statesville, North Carolina  28677
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Kaiser Permanente Health Care - Portland Portland, Oregon  97232
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Bon Secours St. Francis Health System Greenville, South Carolina  29601
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith, Arkansas  72903
California Cancer Center - Woodward Park Office Fresno, California  93720
Kaiser Permanente - Deer Valley Antioch, California  94531
Kaiser Permanente - Moanalua Medical Center and Clinic Honolulu, Hawaii  96819
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Grant Medical Center Cancer Care Columbus, Ohio  43215
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Cancer Centers of the Carolinas - Grove Commons Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris Road Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Sherman Hospital Elgin, Illinois  60120-2198
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Mercy General Health Partners Muskegon, Michigan  49443
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Falck Cancer Center at Arnot Ogden Medical Center Elmira, New York  14905
Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Albuquerque, New Mexico  87110
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
Highland Clinic Shreveport, Louisiana  71105
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
Waverly Hematology Oncology Cary, North Carolina  27518
Kuakini Medical Center Honolulu, Hawaii  96817
Spectrum Health Reed City Hospital Reed City, Michigan  49677
Kaiser Permanente Medical Center - Vacaville Vacaville, California  95688
Mercy Clinic Cancer and Hematology - Rolla Rolla, Missouri  65401
Swedish Medical Center - Issaquah Campus Issaquah, Washington  98029
Oncare Hawaii, Incorporated - Pali Momi Aiea, Hawaii  96701
Kaiser Permanente Fresno Medical Center Fresno, California  93720