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| Overall Recruitment Status: Active, currently enrolling |
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| Official Title |
| Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions |
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| Region |
Sponsors |
| Colorado |
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| Acronym |
KP IRB No. |
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1860357 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
| (Adult, Older Adult) with Anatomic Stage I, II, III Breast Cancer AJCC v8
HER2 Negative Breast Carcinoma,
Hormone Receptor Positive Breast Carcinoma,
Invasive Breast Carcinoma,
Prognostic Stage I, II, III, Breast Cancer AJCC v8
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| 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. |
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| 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. |
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| Gender |
Age Limit |
| Female |
18 years & older |
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- 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
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Patients must have received cancer-directed surgery, and/or completed all other adjuvant therapy, except reconstruction
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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
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Please contact study team for additional inclusion criteria
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- Please contact study team for exclusion criteria
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Neoplasms, Glandular and Epithelial
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Neoplasms by Histologic Type
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