A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer

Study Overview
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Brief Summary
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This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.

Detailed Description
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PRIMARY OBJECTIVES: I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design. SECONDARY OBJECTIVES: I. Conduct mediator analyses of intervention efficacy.. EXPLORATORY OBJECTIVES: I. Explore whether age (=< 45 versus [vs.] > 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress. OUTLINE: PHASE I: Participants attend focus groups on adherence to hormone therapy. PHASE II: Participants are randomized to 1 of 2 groups. GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence. GROUP II: Participants receive usual care. After completion of study, participants are followed up at 3, 6, and 12 months.

Official Title
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A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors

Conditions
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Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor Positive Tumor, Progesterone Receptor Positive Tumor, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

Intervention / Treatment
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* Behavioral: Focus Group
* Other: Text Message
* Other: Best Practice
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman diagnosed with stage I-III breast cancer (BCa). Hormone receptor positive tumor. Completed local definitive treatment (i.e., surgery chemotherapy, radiation). Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen. At least 12 months of AHT recommended. Able to read and understand English. Able to provide informed consent. Have a mobile device with text (TXT) capability. Know or willing to learn how to use TXT. Exclusion Criteria: • Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 (focus groups)<br>Participants attend focus groups on adherence to hormone therapy. | Behavioral: Focus Group<br>* Participate in focus group<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Phase II Group 1 (text messages)<br>Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence. | Other: Text Message<br>* Receive text messages<br>* Other names: Text;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Phase II Group II (usual care)<br>Participants receive usual care. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjuvant hormone therapy (AHT) adherence | Assessed by wireless smart pill bottles for all participants. Daily adherence will be defined as accessing the pill bottle once per 24 hour period. Proportion adherence will be summarized by week and study arm, and presented graphically. | Up to 12 months | 
| Symptom distress | Measured by the Breast Cancer Prevention Trial Symptom Scale, which has sound psychometric properties in breast cancer (BCa) patients. There are a total of 43 items in the scale across eight domains. Each item is a five-point Likert scale, ranging from 0 (not at all) to 4 (extremely), used to rate symptoms. Items accounting for side effects specifically related to AHT (e.g., bone pain) and other general symptoms (e.g., constipation) are added. Participants are asked whether they are bothered by each symptom and whether they think it related to their AHT or not. The two resulting scales consist of the sum of the endorsed symptom total each woman does or does not attribute to AHT. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive-affective barriers for AHT adherence | Will be developed and will test the mediating effect of cognitive affective barriers on proportion of days adherent (average over 12 months) | Up to 12 months | 
| Cognitive-affective barriers for symptom distress | Will be developed and will test the mediating effect of cognitive affective barriers on the difference between baseline and 12-month symptom distress. Symptom distress is measured by the Breast Cancer Prevention Trial Symptom Scale | Up to 12 months |