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ACTIVE NOT RECRUITING

NCT04379570

PHASE3

Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.

Official title: Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1167

Start Date

2021-02-15

Completion Date

2027-10-04

Last Updated

2026-10-19

Healthy Volunteers

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 HER2 Negative Breast Carcinoma Hormone Receptor Positive Breast Carcinoma Invasive Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8

Interventions

OTHER

Educational Intervention

Receive online educational information about ET medication

OTHER

Text Message-based Navigation Intervention

Receive text messages

BEHAVIORAL

Motivational Interviewing

Receive motivational interviewing counseling sessions

OTHER

Best Practice

Attend usual care clinic visits

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

• Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months (\>=548 days) prior to registration. * If a patient has undergone neo-adjuvant chemotherapy and had no residual invasive disease at the time of surgery, eligibility can be based on a clinical stage I-III prior to treatment and pathologic confirmation of receptor status from a diagnostic biopsy. * Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) or both of \> 1% * HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or non-amplified by fluorescence in situ hybridization (FISH) analysis. If HER2-neu status is unknown due to insufficient tissue for evaluation, the patient is eligible * Patients with synchronous primary tumor foci of different receptor phenotypes, whether in the same or contralateral breast, may be enrolled as long as one tumor focus meets the receptor criteria and the patient is otherwise eligible Prior Treatment: * Patients must have completed all planned cancer-directed surgery (except reconstruction surgery or oophorectomy) * Patients must have completed all other adjuvant therapy (e.g., radiation and intravenous \[IV\] or oral chemotherapy) prior to registration * Patients who will be taking a CDK4/6 inhibitor (e.g., abemaciclib, palbociclib, or ribociclib) during endocrine therapy are NOT permitted to enroll as this is considered ongoing adjuvant therapy * Patients who have previously been on ET drug outside the 6-month window for any reason, including breast cancer prevention or high-risk non-malignant lesions (e.g., atypical ductal hyperplasia \[ADH\], lobular carcinoma in situ \[LCIS\]) are ineligible • Patients must be taking a once daily endocrine therapy drug initiated within the 6 months prior to registration, OR have received a prescription for a once daily ET medication with stated intent to initiate within 6 weeks after registration. * Patients who switch ET drugs prior to enrollment remain eligible as long as the total time since initiation of the first ET drug does not exceed 6 months prior to registration * Patients who have stopped their ET drug prior to enrollment and not started another ET drug are ineligible • No history of previous cancer as follows: * Invasive or non-invasive breast cancer at any time * Non-breast cancer, within the past 5 years, excluding non-melanoma skin cancer * Patients with a history of high-risk breast lesions (e.g., atypical ductal hyperplasia - ADH, lobular carcinoma in situ - LCIS are eligible as long as they have not previously taken an endocrine therapy drug • Patients must be willing to use a smart phone for study activities * Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone * A smart phone and service can be provided to the participant at no cost for the duration of the study activities if the participant meets at least one of the following criteria: (1) does not own a smart phone or (2) has limited data, minutes or texting plan or (3) their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey app. Study provided smart phones will be provided through the Ohio State University (OSU) partnership with Verizon Wireless. * The CRP is ONLY to discuss this option with those patients who self-identify a phone-related barrier to participation, including: lack of a smart phone, insufficient phone plan (minutes/text/data), or a smart phone incompatible with the Alliance ePRO app • Patients must be willing to use the AdhereTech medication electronic pill cap for the duration of study participation * Patients must be willing to use the study-provided electronic pill cap as a medication event monitoring system each time ET drug is taken. Use of any other container (e.g., pill box, etc.) for ET drug during study period is not permitted * Age \>= 18 years * In order to complete the mandatory patient-completed measures, participants must be able to speak and read English * Co-enrollment is allowed with the permission of the Alliance Executive Officer and both studies' Study Chairs

Locations (526)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, United States

Arizona Center for Cancer Care - Osborn

Scottsdale, Arizona, United States

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Sutter Auburn Faith Hospital

Auburn, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

UCSF Cancer Center - Berkeley

Berkeley, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Enloe Medical Center

Chico, California, United States

Adventist Health Cancer Care Center Chico

Chico, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente-Ontario

Ontario, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

UCSF Cancer Center - San Mateo

San Mateo, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Saint John's Cancer Institute

Santa Monica, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Kaiser Permanente-Franklin

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Banner McKee Medical Center

Loveland, Colorado, United States

Danbury Hospital

Danbury, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Broward Health North

Deerfield Beach, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Tallahassee Memorial HealthCare

Tallahassee, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Summit Cancer Care-Memorial

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza