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

Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04379570
Enrollment
1167
Registered
2020-05-07
Start date
2021-02-15
Completion date
2027-10-04
Last updated
2026-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

Detailed description

PRIMARY OBJECTIVES: I. Compare endocrine therapy (ET) adherence at 12 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care. SECONDARY OBJECTIVES: l. Compare endocrine therapy (ET) adherence at 24 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care. OUTLINE: Patients are randomized to 1 of 4 arms. ARM I (TMR): Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months. ARM II (MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals. ARM III (TMR + MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II. ARM IV (ENHANCED USUAL CARE): Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer. After completion of study participation, patients are followed up for up to 24 months.

Interventions

OTHEREducational Intervention

Receive online educational information about ET medication

BEHAVIORALMotivational Interviewing

Receive motivational interviewing counseling sessions

OTHERBest Practice

Attend usual care clinic visits

OTHERQuestionnaire Administration

Ancillary studies

OTHERQuality-of-Life Assessment

Ancillary studies

Sponsors

Alliance for Clinical Trials in Oncology
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• 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

Design outcomes

Primary

MeasureTime frameDescription
Endocrine therapy (ET) adherence at 12 months post-randomizationAt 12 months post-randomizationET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (AdhereTech-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days.

Secondary

MeasureTime frameDescription
Endocrine therapy (ET) adherence at 24 months post-randomizationAt 24 months post-randomizationET adherence at 24 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 584 of 730 days.

Countries

United States

Contacts

STUDY_CHAIRKatherine E. Reeder-Hayes, MD

University of North Carolina, Chapel Hill

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 20, 2026