S1105: Text-Messaging Intervention to Reduce Early Discontinuation of AI Therapy in Women With Early-Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515800
• Other study ID #: CDR0000723653
• Secondary ID: S1105U10CA037429
• Status: Completed
• Phase: N/A
• First received: January 21, 2012
• Last updated: March 6, 2018
• Start date: May 2012
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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 recurrent disease; currently receiving chemotherapy.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Text message reminder
Receive text message

Locations

Country	Name	City	State
United States	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii
United States	Oncare Hawaii, Incorporated - Pali Momi	'Aiea	Hawaii
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Hematology Oncology Associates, PC	Albuquerque	New Mexico
United States	Lovelace Medical Center - Downtown	Albuquerque	New Mexico
United States	Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	American Fork Hospital	American Fork	Utah
United States	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington
United States	Alaska Regional Hospital Cancer Center	Anchorage	Alaska
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	Kaiser Permanente - Deer Valley	Antioch	California
United States	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Mecosta County Medical Center	Big Rapids	Michigan
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Highline Medical Center Cancer Center	Burien	Washington
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Waverly Hematology Oncology	Cary	North Carolina
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Clackamas Radiation Oncology Center	Clackamas	Oregon
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Sherman Hospital	Elgin	Illinois
United States	Falck Cancer Center at Arnot Ogden Medical Center	Elmira	New York
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas
United States	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Fort Smith	Arkansas
United States	Middletown Regional Hospital	Franklin	Ohio
United States	Kaiser Permanente - Fremont	Fremont	California
United States	California Cancer Center - Woodward Park Office	Fresno	California
United States	Kaiser Permanente Fresno Medical Center	Fresno	California
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Bon Secours St. Francis Health System	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Wayne Hospital	Greenville	Ohio
United States	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Kaiser Permanente Medical Center - Hayward	Hayward	California
United States	St. Peter's Hospital	Helena	Montana
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Cancer Research Center of Hawaii	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	Kuakini Medical Center	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Kuakini	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	Tripler Army Medical Center	Honolulu	Hawaii
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Swedish Medical Center - Issaquah Campus	Issaquah	Washington
United States	Foote Memorial Hospital	Jackson	Michigan
United States	Castle Medical Center	Kailua	Hawaii
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas
United States	Kauai Medical Clinic	Lihue	Hawaii
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	Logan Regional Hospital	Logan	Utah
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Winthrop University Hospital	Mineola	New York
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	Mercy General Health Partners	Muskegon	Michigan
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Providence Newberg Medical Center	Newberg	Oregon
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Kaiser Permanente Medical Center - Oakland	Oakland	California
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Willamette Falls Hospital	Oregon City	Oregon
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Kaiser Permanente Health Care - Portland	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio
United States	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Kaiser Permanente Medical Center - Redwood City	Redwood City	California
United States	Spectrum Health Reed City Hospital	Reed City	Michigan
United States	Kaiser Permanente Medical Center - Richmond	Richmond	California
United States	Reid Hospital & Health Care Services	Richmond	Indiana
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	Mercy Clinic Cancer and Hematology - Rolla	Rolla	Missouri
United States	Kaiser Permanente Medical Center - Roseville	Roseville	California
United States	Kaiser Permanente Medical Center - Sacramento	Sacramento	California
United States	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	LDS Hospital	Salt Lake City	Utah
United States	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California
United States	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California
United States	Kaiser Foundation Hospital - San Rafael	San Rafael	California
United States	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington
United States	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	Highland Clinic	Shreveport	Louisiana
United States	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California
United States	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan
United States	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Evergreen Hematology and Oncology, PS	Spokane	Washington
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	Kaiser Permanente Medical Facility - Stockton	Stockton	California
United States	Cotton-O'Neil Cancer Center	Topeka	Kansas
United States	Munson Medical Center	Traverse City	Michigan
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Kaiser Permanente Medical Center - Vacaville	Vacaville	California
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California
United States	St. John Macomb Hospital	Warren	Michigan
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina
United States	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Air Force Base	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first evidence of adherence failure (discontinuation)		Every 3 months after randomization
Secondary	Adherence effect of text message compared to usual care using the patient self-report responses to AI Usage form		Every 3 months after randomization
Secondary	Relationship between randomized arm and various participant, site and health insurance characteristics	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.	Every 3 months after randomization
Secondary	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
Secondary	Time to last evidence of adherence		Every 3 months after randomization