Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy
Purpose
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.
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Criteria
- Women with an initial pathologically confirmed diagnosis of stage I-III, hormone
receptor positive, HER2-neu negative, invasive breast cancer within 18 months prior
to enrollment
- Women who have undergone neo-adjuvant chemotherapy who have no residual
invasive disease post-surgery are eligible based on an initial pathologically
confirmed diagnosis
- Hormone receptor positive is defined as estrogen receptor (ER) and/or
progesterone receptor (PR) of > 1%
- HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or
non-amplified by fluorescence in situ hybridization (FISH) analysis
- Patients must have received cancer-directed surgery, and/or completed all other
adjuvant therapy, except reconstruction
- Patients must have initiated an endocrine therapy drug within the 6 months prior to
registration, OR have received a prescription with stated intent to initiate within
6 weeks after registration
- 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 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
- If a participant does not own a smart phone or has limited data or texting
capabilities or their smart phone cannot support the Alliance electronic
patient reported outcomes (ePRO) survey application (app), a smart phone and
service can be provided to the participant at no cost through the Ohio State
University (OSU) partnership with Verizon Wireless for the duration of the
study activities
- 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
- For OSU -provided phones, charges will be paid by the grant through the
intervention period. At the end of the 12-month intervention period, patients
will be responsible for paying monthly fees, if continued service is desired.
The physical phones will belong to the patients at the end of their study
activities
- Patients must be willing to use a Pillsy medication event monitoring system for the
duration of study participation
- In order to complete the mandatory patient-completed measures, participants must be
able to speak and read English
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Experimental 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. |
|
|
Experimental 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. |
|
|
Active Comparator 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. |
|
Recruiting Locations
Cleveland, Ohio 44109
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
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.