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

Official record

Identifier

NCT04379570

Recruiting locations

country

United States

Interventions studied

Educational InterventionText Message-based Navigation InterventionMotivational InterviewingBest PracticeQuestionnaire AdministrationQuality-of-Life Assessment

Lead sponsor

Alliance for Clinical Trials in Oncology

Target enrolment

1167 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

May 7, 2020

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

FEMALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

• 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

Indexed under

Breast Cancer