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S1105: Text-Messaging Interve...

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

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

724 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Text message reminder

Intervention Type BEHAVIORAL

Receive text message

No text message reminder

Patients receive standard follow-up care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text message reminder

Receive text message

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfred I. Neugut, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Herbert Irving Comprehensive Cancer Center

Locations

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Alaska Regional Hospital Cancer Center

Anchorage, Alaska, United States

Site Status

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Kaiser Permanente - Deer Valley

Antioch, California, United States

Site Status

Kaiser Permanente - Fremont

Fremont, California, United States

Site Status

California Cancer Center - Woodward Park Office

Fresno, California, United States

Site Status

Kaiser Permanente Fresno Medical Center

Fresno, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Kaiser Permanente Medical Center - Oakland

Oakland, California, United States

Site Status

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente Medical Center - Richmond

Richmond, California, United States

Site Status

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States

Site Status

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Site Status

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Site Status

Kaiser Permanente Medical Center - Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

Site Status