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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Text message reminder

About this trial

This is an interventional other trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Alaska Regional Hospital Cancer Center
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Kaiser Permanente - Deer Valley
Kaiser Permanente - Fremont
California Cancer Center - Woodward Park Office
Kaiser Permanente Fresno Medical Center
Kaiser Permanente Medical Center - Hayward
Kaiser Permanente Medical Center - Oakland
Kaiser Permanente Medical Center - Redwood City
Kaiser Permanente Medical Center - Richmond
Kaiser Permanente Medical Center - Roseville
South Sacramento Kaiser-Permanente Medical Center
Kaiser Permanente Medical Center - Sacramento
Kaiser Permanente Medical Center - San Francisco Geary Campus
Kaiser Permanente Medical Center - Santa Teresa
Kaiser Foundation Hospital - San Rafael
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Kaiser Permanente Medical Center - Santa Rosa
Kaiser Permanente Medical Center - South San Francisco
Kaiser Permanente Medical Facility - Stockton
Kaiser Permanente Medical Center - Vacaville
Kaiser Permanente Medical Center - Vallejo
Kaiser Permanente Medical Center - Walnut Creek
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Kapiolani Medical Center at Pali Momi
Oncare Hawaii, Incorporated - Pali Momi
Cancer Research Center of Hawaii
OnCare Hawaii, Incorporated - Lusitana
Queen's Cancer Institute at Queen's Medical Center
Straub Clinic and Hospital, Incorporated
OnCare Hawaii, Incorporated - Kuakini
Kuakini Medical Center
Kaiser Permanente - Moanalua Medical Center and Clinic
Kapiolani Medical Center for Women and Children
Tripler Army Medical Center
Castle Medical Center
Kauai Medical Clinic
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Decatur Memorial Hospital Cancer Care Institute
Sherman Hospital
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Good Samaritan Regional Health Center
Regional Cancer Center at Memorial Medical Center
St. Francis Hospital and Health Centers - Beech Grove Campus
Reid Hospital & Health Care Services
Genesis Regional Cancer Center at Genesis Medical Center
Cancer Center of Kansas, PA - Chanute
Cancer Center of Kansas, PA - Dodge City
Cancer Center of Kansas - Fort Scott
Cancer Center of Kansas-Independence
Cancer Center of Kansas, PA - Kingman
Lawrence Memorial Hospital
Cancer Center of Kansas, PA - Liberal
Cancer Center of Kansas, PA - Newton
Cancer Center of Kansas, PA - Parsons
Cancer Center of Kansas, PA - Pratt
Cancer Center of Kansas, PA - Salina
Cotton-O'Neil Cancer Center
Cancer Center of Kansas, PA - Wellington
Associates in Womens Health, PA - North Review
Cancer Center of Kansas, PA - Medical Arts Tower
Cancer Center of Kansas, PA - Wichita
CCOP - Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center
Cancer Center of Kansas, PA - Winfield
Highland Clinic
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Boston University Cancer Research Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
Battle Creek Health System Cancer Care Center
Mecosta County Medical Center
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Josephine Ford Cancer Center at Henry Ford Hospital
Genesys Hurley Cancer Institute
Hurley Medical Center
Butterworth Hospital at Spectrum Health
CCOP - Grand Rapids
Lacks Cancer Center at Saint Mary's Health Care
Van Elslander Cancer Center at St. John Hospital and Medical Center
Foote Memorial Hospital
Sparrow Regional Cancer Center
St. Mary Mercy Hospital
Mercy General Health Partners
St. Joseph Mercy Oakland
Mercy Regional Cancer Center at Mercy Hospital
Spectrum Health Reed City Hospital
Seton Cancer Institute at Saint Mary's - Saginaw
Providence Cancer Institute at Providence Hospital - Southfield Campus
Munson Medical Center
St. John Macomb Hospital
Saint Francis Medical Center
Mercy Clinic Cancer and Hematology - Rolla
Midwest Hematology Oncology Group, Incorporated
CCOP - St. Louis-Cape Girardeau
David C. Pratt Cancer Center at St. John's Mercy
CCOP - Cancer Research for the Ozarks
St. John's Regional Health Center
Hulston Cancer Center at Cox Medical Center South
CCOP - Montana Cancer Consortium
St. Vincent Healthcare Cancer Care Services
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
Great Falls Clinic - Main Facility
Sletten Cancer Institute at Benefis Healthcare
St. Peter's Hospital
Glacier Oncology, PLLC
Kalispell Regional Medical Center
Montana Cancer Specialists at Montana Cancer Center
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Good Samaritan Cancer Center at Good Samaritan Hospital
Lovelace Medical Center - Downtown
Hematology Oncology Associates, PC
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
University of New Mexico Cancer Center
New Mexico Cancer Care Associates
Falck Cancer Center at Arnot Ogden Medical Center
Tucker Center for Cancer Care at Orange Regional Medical Center
Winthrop University Hospital
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Highland Hospital of Rochester
James P. Wilmot Cancer Center at University of Rochester Medical Center
Waverly Hematology Oncology
Wayne Memorial Hospital, Incorporated
Pardee Memorial Hospital
Iredell Memorial Hospital
Forsyth Regional Cancer Center at Forsyth Medical Center
McDowell Cancer Center at Akron General Medical Center
Adena Regional Medical Center
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Medical Center Cancer Care
Mount Carmel Health - West Hospital
Doctors Hospital at Ohio Health
Grandview Hospital
Good Samaritan Hospital
David L. Rike Cancer Center at Miami Valley Hospital
Samaritan North Cancer Care Center
CCOP - Dayton
Grady Memorial Hospital
Blanchard Valley Medical Associates
Middletown Regional Hospital
Wayne Hospital
Charles F. Kettering Memorial Hospital
Fairfield Medical Center
Strecker Cancer Center at Marietta Memorial Hospital
Knox Community Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Southern Ohio Medical Center Cancer Center
Community Hospital of Springfield and Clark County
UVMC Cancer Care Center at Upper Valley Medical Center
Mount Carmel St. Ann's Cancer Center
United States Air Force Medical Center - Wright-Patterson
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Genesis - Good Samaritan Hospital
Clackamas Radiation Oncology Center
Providence Milwaukie Hospital
Providence Newberg Medical Center
Willamette Falls Hospital
Providence Cancer Center at Providence Portland Medical Center
CCOP - Columbia River Oncology Program
Providence St. Vincent Medical Center
Kaiser Permanente Health Care - Portland
Bon Secours St. Francis Health System
Cancer Centers of the Carolinas - Faris Road
Cancer Centers of the Carolinas - Grove Commons
CCOP - Greenville
Cancer Centers of the Carolinas - Greer Medical Oncology
Cancer Centers of the Carolinas - Seneca
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Cancer Centers of the Carolinas - Spartanburg
Brooke Army Medical Center
American Fork Hospital
Sandra L. Maxwell Cancer Center
Logan Regional Hospital
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center - East Campus
LDS Hospital
Island Hospital Cancer Care Center at Island Hospital
St. Joseph Cancer Center
Olympic Hematology and Oncology
Highline Medical Center Cancer Center
Swedish Medical Center - Issaquah Campus
Columbia Basin Hematology
Skagit Valley Hospital Cancer Care Center
Harrison Poulsbo Hematology and Onocology
Harborview Medical Center
Minor and James Medical, PLLC
Fred Hutchinson Cancer Research Center
Group Health Central Hospital
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Polyclinic First Hill
University Cancer Center at University of Washington Medical Center
North Puget Oncology at United General Hospital
Cancer Care Northwest - Spokane South
Evergreen Hematology and Oncology, PS
Southwest Washington Medical Center Cancer Center
Wenatchee Valley Medical Center
Rocky Mountain Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text message reminder

No text message reminder

Arm Description

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.

Patients receive standard follow-up care.

Outcomes

Primary Outcome Measures

Time to first evidence of adherence failure (discontinuation)

Secondary Outcome Measures

Adherence effect of text message compared to usual care using the patient self-report responses to AI Usage form

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.

Reasons for early discontinuation of AI therapy among intervention arm and control arm as assessed by quality-of-life questionnaires

Time to last evidence of adherence

Full Information

NCT ID

NCT01515800

First Posted

January 21, 2012

Last Updated

March 6, 2018

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01515800

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

724 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Text message reminder

Arm Type

Experimental

Arm Description

Arm Title

No text message reminder

Arm Type

No Intervention

Arm Description

Patients receive standard follow-up care.

Intervention Type

Behavioral

Intervention Name(s)

Text message reminder

Intervention Description

Receive text message

Primary Outcome Measure Information:

Title

Time to first evidence of adherence failure (discontinuation)

Time Frame