Know Cancer

or
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


N/A
18 Years
N/A
Open (Enrolling)
Female
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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT 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:

Interventional

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:

No

Principal Investigator

Alfred I. Neugut, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000723653

NCT ID:

NCT01515800

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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
LDS HospitalSalt Lake City, Utah  84143
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Winthrop University HospitalMineola, New York  11501
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Kaiser Permanente - FremontFremont, California  94538
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Mecosta County Medical CenterBig Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Highland Hospital of RochesterRochester, New York  14620
Iredell Memorial HospitalStatesville, North Carolina  28677
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Kaiser Permanente Health Care - PortlandPortland, Oregon  97232
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, Arkansas  72903
California Cancer Center - Woodward Park OfficeFresno, California  93720
Kaiser Permanente - Deer ValleyAntioch, California  94531
Kaiser Permanente - Moanalua Medical Center and ClinicHonolulu, Hawaii  96819
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Grant Medical Center Cancer CareColumbus, Ohio  43215
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Pardee Memorial HospitalHendersonville, North Carolina  28791
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Sherman HospitalElgin, Illinois  60120-2198
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Mercy General Health PartnersMuskegon, Michigan  49443
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
Lovelace Medical Center - DowntownAlbuquerque, New Mexico  87102
Hematology Oncology Associates, PCAlbuquerque, New Mexico  87106
Falck Cancer Center at Arnot Ogden Medical CenterElmira, New York  14905
Castle Medical CenterKailua, Hawaii  96734
Kauai Medical ClinicLihue, Hawaii  96766
Presbyterian Cancer Treatment Center at Presbyterian Kaseman HospitalAlbuquerque, New Mexico  87110
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Willamette Falls HospitalOregon City, Oregon  97045
Island Hospital Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center Cancer CenterBurien, Washington  98166
Highland ClinicShreveport, Louisiana  71105
Southern Ohio Medical Center Cancer CenterPortsmouth, Ohio  45662
Waverly Hematology OncologyCary, North Carolina  27518
Kuakini Medical CenterHonolulu, Hawaii  96817
Spectrum Health Reed City HospitalReed City, Michigan  49677
Kaiser Permanente Medical Center - VacavilleVacaville, California  95688
Mercy Clinic Cancer and Hematology - RollaRolla, Missouri  65401
Swedish Medical Center - Issaquah CampusIssaquah, Washington  98029
Oncare Hawaii, Incorporated - Pali MomiAiea, Hawaii  96701
Kaiser Permanente Fresno Medical CenterFresno, California  93720